Minneapolis, MN, United States

Smiths Medical ASD Inc. recalls

73 recalls recorded since 2018, most recently on 10 April 2025. 33 are listed as ongoing. Status and classification are as published by the FDA.

Recalls73

Ongoing (FDA)33

Terminated or completed40

Class I (FDA)21

Ongoing Class I Medical devices

Recall started: 10 April 2025
Reason: Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Distribution: Worldwide - US nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1667-2025, Z-1668-2025

CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEM
CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-2120-0100-95 21-2120-0102-02 21-21

Ongoing Class I Medical devices

Recall started: 10 April 2025
Reason: There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Distribution: Worldwide - US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1682-2025, Z-1681-2025

CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-01; 2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD
CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA, Model Number: 21

Ongoing Class I Medical devices

Recall started: 10 April 2025
Reason: Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Distribution: Worldwide - US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-1662-2025

CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope: PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3,

Ongoing Class II Medical devices

Recall started: 14 February 2025
Reason: Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.
Distribution: US Nationwide distribution. International distribution pending.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1404-2025, Z-1405-2025

CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214

Ongoing Class I Medical devices

Recall started: 13 February 2025
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Distribution: Worldwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1286-2025, Z-1287-2025, Z-1285-2025, Z-1284-2025, Z-1282-2025, Z-1278-2025, Z-1277-2025, Z-1288-2025, Z-1279-2025, Z-1283-2025, Z-1281-2025, Z-1280-2025

smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24
and 4 more product lines

Ongoing Class I Medical devices

Recall started: 13 February 2025
Reason: Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.
Distribution: Worldwide - US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-1289-2025

Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100

Ongoing Class II Medical devices

Recall started: 28 October 2024
Reason: Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
Distribution: Worldwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0528-2025, Z-0529-2025, Z-0527-2025

smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

Ongoing Class II Medical devices

Recall started: 24 September 2024
Reason: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
Distribution: Worldwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0187-2025, Z-0205-2025, Z-0193-2025, Z-0202-2025, Z-0185-2025, Z-0194-2025, Z-0200-2025, Z-0199-2025, Z-0189-2025, Z-0204-2025, Z-0201-2025, Z-0195-2025 and 12 more

medex Arterial Kit 1/EA, Product Code REF MX7827
smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714
medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242
medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT
medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547
medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545
and 16 more product lines

Ongoing Class II Medical devices

Recall started: 18 July 2024
Reason: Uncertainty in the seal integrity of the sterile packaging.
Distribution: Worldwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0146-2025, Z-0143-2025, Z-0145-2025, Z-0147-2025, Z-0144-2025

smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060JP; c) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070;
smiths medical portex, Y' PIECE 15MM, REF 100/276/000
smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; b) REF 100/255/150JP; c) REF 100/255/150 JS

Ongoing Class I Medical devices

Recall started: 16 July 2024
Reason: Damage to the battery pack may have caused a short to a capacitor within the battery pack. While the battery encasement is designed to be flame retardant, a short to the capacitor could lead to melting of the battery pack case. If this issue occurs, the battery pack charging circuit may become inoperable.
Distribution: Worldwide Distribution
Initiated: Voluntary: Firm initiated
Recall number: Z-0222-2025

CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Systems: 21-2101-0100-50, 21-2101-0200-02, 21-2101-0200-03, 21-2101-0200-0

Ongoing Class II Medical devices

Recall started: 26 June 2024
Reason: Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Distribution: Worldwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0015-2025, Z-0018-2025, Z-0010-2025, Z-0017-2025, Z-0012-2025, Z-0011-2025, Z-0013-2025, Z-0014-2025, Z-0016-2025

CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24
CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24
and 1 more product lines

Ongoing Class II Medical devices

Recall started: 26 June 2024
Reason: The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or one or more of the AC mains prongs may separate from the input plug.
Distribution: Worldwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-0466-2025

smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps

Ongoing Class I Medical devices

Recall started: 7 June 2024
Reason: There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a manufacturing defect.
Distribution: Worldwide
Initiated: Voluntary: Firm initiated
Recall numbers: Z-3086-2024, Z-3088-2024, Z-3087-2024

smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/060CZ; 2) BLUSELECT 7.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/070CZ; 3) BLU
smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows: 1) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUsele
smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows: 1) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect trach tu

Ongoing Class I Medical devices

Recall started: 31 May 2024
Reason: There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.
Distribution: Worldwide
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2974-2024, Z-2973-2024

Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
Pneupac paraPAC plus 300 ventilator kit, REF P300NXX

Ongoing Class I Medical devices

Recall started: 31 May 2024
Reason: Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function.
Distribution: Worldwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-3090-2024, Z-3091-2024

paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

Ongoing Class I Medical devices

Recall started: 29 May 2024
Reason: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
Distribution: Worldwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2599-2024, Z-2614-2024, Z-2600-2024, Z-2602-2024, Z-2592-2024, Z-2598-2024, Z-2612-2024, Z-2601-2024, Z-2591-2024, Z-2608-2024, Z-2606-2024, Z-2615-2024 and 16 more

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , P
a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH NEONATE STRAIGHT NECKSTRAP, Product Code/List Number/Item Code 60PFSS25
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/It
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Product Code/List
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Prod
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FL
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE
and 20 more product lines

Ongoing Class I Medical devices

Recall started: 27 February 2024
Reason: The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.
Distribution: Worldwide
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2421-2024, Z-2419-2024, Z-2420-2024

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraopera
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative s
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subara

Ongoing Class I Medical devices

Recall started: 7 February 2024
Reason: When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This non-cycling and continuous positive gas flow when in the cycling mode, is a malfunction, not allowing the ventilator to properly function as designed.
Distribution: Worldwide distribution: US (nationwide) and OUS countries of: Algeria, Armenia, Australia, Austria, Bangladesh, Bahrain, Bolivia, Plurinational state of, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Cyprus, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Hong Kong, Iceland, Ind
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1274-2024, Z-1275-2024

smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

Ongoing Class I Medical devices

Recall started: 19 December 2023
Reason: Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion Restarted with Incorrect Parameters, 3. Screen Lock, 4. Interruption of Bolus or Loading Dose Delivery, 5. Pump Displays Incorrect Bolus/Loading Dose, 6. Loading/Bolus Dose Below the Minimum Recommended Rate, 7. Motor Rate Error, 8. Incorrect Recall Last Settings, 9. Corrupt Configuration, 10. Auto Lock, 11. Toolbox Configuration Loading Dose Time Values. Smiths Medical corrected all issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent Medfusion software (v6.0.0) installed on your pumps.
Distribution: worldwide
Initiated: Voluntary: Firm initiated
Recall number: Z-0863-2024

smiths medical Medfusion Model 3500 Syringe pump

Ongoing Class II Medical devices

Recall started: 19 December 2023
Reason: Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
Distribution: Worldwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1541-2024, Z-1543-2024, Z-1540-2024, Z-1542-2024

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00,
Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k
Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E

Ongoing Class I Medical devices

Recall started: 19 December 2023
Reason: Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. Delivery During Motor Not Running High Priority Alarm (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 2. Re-administered Loading Dose (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 3. Incorrect Critical Data Failure Alarm, 4. Interruption of Bolus or Loading Dose Delivery (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 5. Incorrect Total Bolus/Loading Dose Displayed (v1.1.0, v1.1.1, v1.1.2), 6. Volume Limit Before Bolus/Loading Dose Complete (v1.1.2), 7. Drug Library Lower Limit Displayed Incorrectly (v1.6.0, v1.6.1), 8. Depleted Battery Alarm (All versions previous to v1.6.5), 9. Loss of Wireless Connectivity (v1.5.0, v1.5.1, v1.6.0, v1.6.1, v1.6.4), 10. PharmGuard Server Password (v2.3, v2.4, v2.5). Smiths Medical corrected all issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent Medfusion software installed on your pumps.
Distribution: US nationwide, Canada, Great Britain, Bermuda, Australia, Germany, Singapore, Saudi Arabia, Lebanon, and Malaysia
Initiated: Voluntary: Firm initiated
Recall number: Z-0864-2024

smiths medical Medfusion Model 4000 syringe pump

Ongoing Class II Medical devices

Recall started: 10 November 2023
Reason: There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, UAE.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0747-2024, Z-0746-2024, Z-0740-2024, Z-0743-2024, Z-0744-2024, Z-0741-2024, Z-0739-2024, Z-0745-2024, Z-0742-2024

48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP
HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP
6IN PRESSURE TUBING, List Number MX20617
Medex LOGICAL CATH LAB KIT, List Number M20754
20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR
and 1 more product lines

Ongoing Class II Medical devices

Recall started: 6 September 2023
Reason: The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the packaging of Pro-Vent Arterial Blood Sampling (ABG) Kits. Specifically, this issue affected a total of 31,900 kits under the FGSKU# 4599P-1 and Lot# 4331283. Tubes without caps have the potential to generate delayed or erroneous test results and/or exposure to infectious blood.
Distribution: US
Initiated: Voluntary: Firm initiated
Recall number: Z-0141-2024

Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1

Ongoing Class II Medical devices

Recall started: 22 August 2023
Reason: The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).
Distribution: Distribution was made to AZ, CA, FL, HI, IL, IN, MA, MN, MO, MS, NC, NJ, OH, PA, SC, TX, VA, and WA. There was no government/military distribution. Foreign distribution was made to Canada.
Initiated: Voluntary: Firm initiated
Recall number: Z-0205-2024

Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.

Ongoing Class II Medical devices

Recall started: 16 August 2023
Reason: A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0076-2024, Z-0078-2024, Z-0079-2024, Z-0077-2024, Z-0081-2024, Z-0080-2024

Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 0600-249; software versions: v3, v4, v5, and v6
Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0101-249, g) 0105-51, h) 0105-78, i) 0105-249, j) 0106-00, k) 0106-01, l) 0106-231, m)
Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6
Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pump
Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump

Ongoing Class II Medical devices

Recall started: 18 July 2023
Reason: Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-2466-2023

PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter

Ongoing Class II Medical devices

Recall started: 5 April 2023
Reason: DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, New Zealand, and Hong Kong.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1580-2023, Z-1582-2023, Z-1581-2023

DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits
DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Port for use with breathing circuits
DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elbow for use with breathing circuits

Ongoing Class I Medical devices

Recall started: 9 December 2022
Reason: There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
Distribution: Worldwide Distribution: US (nationwide) and OUS countries of: CH, CA, ES, FR, AT, BE, IT, DK, NO, EE, DE, NL, AU, GB, SE, PL, SA, IN, IL, PT, CZ, IE, NZ, LU, SI, ZA, BM, SG, MQ, CL, LB, MY, HU, JP, TW, and CN
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0963-2023, Z-0962-2023, Z-0966-2023, Z-0965-2023, Z-0964-2023

CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7323-24, 7) REF 21-7324-24, 8) REF 21-7333-24, 9) REF 21-7336-24, 10
CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24, 6) REF 21-7310-24, 7) REF 21-7322-24, 8) REF 21-7323-24, 9) REF 21-7324-24,
CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f) REF 21-7609-24JP, g) REF 21-7624-24JP, h) REF 21-7649-24JP Computerized
CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP, e) REF 21-7309-24JP. Computerized Ambulatory Delivery Device

Ongoing Class II Medical devices

Recall started: 10 October 2022
Reason: Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation
Distribution: US distribution to states of: Indiana, Texas and Virginia
Initiated: Voluntary: Firm initiated
Recall number: Z-0272-2023

Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requi

Ongoing Class I Medical devices

Recall started: 18 April 2022
Reason: Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) - Infusion Continues after System Failure, 5. Clearing of Program Volume Delivered (PVD), 6. False Alarm for Rate Below Recommended Minimum for Syringe Size, 7. Incorrect Bolus or Loading Dose Time Display, 8. Domain Name Server (DNS) Port 1001
Distribution: Worldwide distribution. US nationwide including US Virgin Islands, Countries of: AE, AL, AT, AU, BE, BM, BN, BS, CA, CH, CL, CY, CZ, DE, DK, DO, ES, FI, FR, GB, HK, HU, ID, IE, IL, IN, IR, IT, KR, KW, LB, LK, MU, MX, MY, NL, NZ, OM, PA, PH, PK, PL, PT, QA, SA, SE, SG, TR, TT, VI, and VN.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1272-2022, Z-1271-2022

Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-414, 3500-415, 3500-500, 3500BC, 3500E, 3500G, 3500SD, 3500SD-500, 3500V
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4

Terminated Class II Medical devices

Recall started: 9 August 2021
Terminated: 13 October 2023
Reason: Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, IL, KY, MA, MN, MO, NE, NJ, NY, OH, PA, SD, TN, TX, VA, WA and Hawaii. The countries of Bermuda, Canada, Germany, Denmark, Great Britain and Italy.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0177-2022, Z-0178-2022

Bivona Aire-Cuf Endotracheal Tube
Bivona Uncuffed Wire Endotracheal Tubes,

Ongoing Class I Medical devices

Recall started: 6 August 2021
Reason: There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.
Distribution: US Nationwide Distribution and PR OUS distribution in - Austria, Australia, Belgium, Switzerland, Canada, Germany, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Hungary, Ireland, Italy, Kuwait, Luxembourg, Netherlands, New Zealand, Panama, Poland, Portugal, Sweden, Turkey, Venezuela,
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2377-2021, Z-2376-2021

NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129

Terminated Class II Medical devices

Recall started: 4 August 2021
Terminated: 11 March 2025
Reason: The incorrect device is contained in the package.
Distribution: International distribution was made to the countries of Canada, Japan, Indonesia, and Spain.
Initiated: Voluntary: Firm initiated
Recall number: Z-2401-2021

smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.

Terminated Class III Medical devices

Recall started: 15 July 2021
Terminated: 11 August 2023
Reason: Two devices were labeled with the same serial number
Distribution: UK
Initiated: Voluntary: Firm initiated
Recall number: Z-0163-2022

Pneupac paraPac plus 300 ventilator kit, REF P300NGB

Terminated Class I Medical devices

Recall started: 17 May 2021
Terminated: 11 October 2023
Reason: Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings on the syringe barrel were skewed approximately 20 degrees upward.
Distribution: Worldwide distribution - US Nationwide and the countries of UK, Spain.
Initiated: Voluntary: Firm initiated
Recall number: Z-1798-2021

JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G X 1/2" (0.33mm x 13mm), REF 4429-1

Terminated Class II Medical devices

Recall started: 14 May 2021
Terminated: 9 June 2023
Reason: One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit.
Distribution: US Nationwide distribution in the states of PA, MI, MD, FL.
Initiated: Voluntary: Firm initiated
Recall number: Z-1993-2021

PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel

Terminated Class II Medical devices

Recall started: 31 March 2021
Terminated: 20 March 2023
Reason: Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
Distribution: Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1480-2021, Z-1472-2021, Z-1477-2021, Z-1470-2021, Z-1473-2021, Z-1476-2021, Z-1474-2021, Z-1481-2021, Z-1479-2021, Z-1478-2021, Z-1475-2021, Z-1471-2021

Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressure Transducer.
Left Heart Kit, Model Number M20268. for blood pressure monitoring.
Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number MX1431MRL c. 700 PSI STPCK W/ ROTATOR, Model Number MX4331R. Stopcocks
LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling.
LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.
Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1233MR c. 550 2 GANG MANIFOLD ROTATOR, OPEN HANDLE, Model Numb
Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid flow.
Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.
and 4 more product lines

Terminated Class II Medical devices

Recall started: 31 March 2021
Terminated: 31 January 2023
Reason: The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.
Distribution: Worldwide distribution - US Nationwide distribution in the states of PA and MN. The countries of Columbia, Germany, Greece, Hong Kong, Qatar, Thailand, and United Arab Emirates.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1516-2021, Z-1515-2021

ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters and with mechanically ventilated patients.
Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within the bronchial tree.

Terminated Class II Medical devices

Recall started: 18 January 2021
Terminated: 20 December 2022
Reason: Smiths Medical became aware that three lot numbers of a specific model of Bivona¿ Cuffless FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) may have been incorrectly packaged with a straight neck flange instead of a V-neck flange. As a result, there is potential for patient injury if an incorrect device or accessory is selected for use. This use could lead to an internal injury resulting from excessive device contact with tissue, or an external patient injury due to external portions of the device pressing into or rubbing against tissue.
Distribution: US Nationwide distribution including in the states of AL, AZ, CA, CT, FL, GA, IA, IL, KS, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TX, UT, VA, and WA.
Initiated: Voluntary: Firm initiated
Recall number: Z-1145-2021

Tube Tracheostomy and Tube Cuff, Bivona¿ Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) V Neck Flange 4.5mm - Product Usage: intended to provide direct airway

Terminated Class II Medical devices

Recall started: 21 December 2020
Terminated: 11 July 2024
Reason: Shipping box may contain wrong model.
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, MD, ME, MI, MO, MS, NC, NE, NJ, OH, OR, PA, SC, TN, TX, UT, VA, WV and the countries of Austria, Canada, Chile, Czech Republic, France, Germany, Italy, Thailand.
Initiated: Voluntary: Firm initiated
Recall number: Z-0874-2021

Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory Pressure (PEP) Therapy for patients who have Cystic Fibrosis, COPD, asthma, and lung diseases with se

Terminated Class II Medical devices

Recall started: 15 December 2020
Terminated: 20 December 2022
Reason: A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.
Distribution: US nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-0726-2021

PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45

Terminated Class II Medical devices

Recall started: 8 December 2020
Terminated: 4 August 2023
Reason: The labeling was missing information on sterilization and prohibition of reuse.
Distribution: Canada. Belgium, Great Britain, Ireland, Czech Republic, Spain, France, Switzerland, Israel, Germany, Sweden, Italy, New Zealand, Australia, South Africa, Netherlands, Slovenia, United Arab Emirates
Initiated: Voluntary: Firm initiated
Recall number: Z-0152-2022

smiths medical portex Loss of Resistance Device, REF 100/398/000

Terminated Class II Medical devices

Recall started: 28 August 2020
Terminated: 13 May 2021
Reason: Label has the incorrect size for the tracheotomy tube.
Distribution: US Distribution to state of: CT
Initiated: Voluntary: Firm initiated
Recall number: Z-2946-2020

Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use.

Terminated Class II Medical devices

Recall started: 14 July 2020
Terminated: 4 August 2023
Reason: Product may have been manufactured with an air filter assembled in an incorrect orientation.
Distribution: Canada
Initiated: Voluntary: Firm initiated
Recall number: Z-0148-2022

CADD Administration Sets, Model #21-7346-24

Ongoing Class I Medical devices

Recall started: 26 June 2020
Reason: Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
Distribution: Worldwide distribution - United Arab Emirates, United States, Afghanistan, Albania, Australia, Belgium, Bermuda, Canada, China, Germany, Denmark, Great Britain, Hong Kong, Indonesia, Ireland, India, Korea, Kuwait, Lebanon, Mexico, Malaysia, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, S
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2734-2020, Z-2735-2020

Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.

Terminated Class II Medical devices

Recall started: 11 June 2020
Terminated: 25 January 2021
Reason: Smiths Medical became aware that one (1) lot of PORT-A-CATH¿ II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter instead of a 6Fr catheter.
Distribution: Domestic Distribution: AR, CT, MS,TN,TX
Initiated: Voluntary: Firm initiated
Recall number: Z-2499-2020

PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.

Terminated Class II Medical devices

Recall started: 26 May 2020
Terminated: 5 May 2021
Reason: One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.
Distribution: U.S: NE, TN, TX, and MS. Worldwide: France, Sweden, United Arab Emirates, UK, Netherlands, Czechia, Australia and Denmark.
Initiated: Voluntary: Firm initiated
Recall number: Z-2485-2020

Pediatric Adjustable Flange Tracheostomy Tube Cuffless

Terminated Class I Medical devices

Recall started: 24 March 2020
Terminated: 22 December 2023
Reason: Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. If an AILD does not sufficiently discern fluid from air in line, an air in line event may not be recognized by the pump and may not alarm to notify the clinician.
Distribution: Distribution to European countries: BE, BH, CH, DE, DK, ES, FI, FR, GB, IT, HL, NO, PT, SE
Initiated: Voluntary: Firm initiated
Recall number: Z-0107-2022

CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-

Terminated Class II Medical devices

Recall started: 10 March 2020
Terminated: 22 September 2023
Reason: Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Distribution: Austria, France, Germany, Great Britain, and Saudi Arabia
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0101-2022, Z-0099-2022, Z-0102-2022, Z-0096-2022, Z-0092-2022, Z-0103-2022, Z-0094-2022, Z-0095-2022, Z-0098-2022, Z-0097-2022, Z-0100-2022, Z-0093-2022

smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092
smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090
smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093
smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082
medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094
smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076
smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081
and 4 more product lines

Terminated Class II Medical devices

Recall started: 28 February 2020
Terminated: 1 September 2021
Reason: Cases of Portex¿ Lumbar Puncture Tray Child, SKU #4826PL-20 had been mislabeled with invalid information. The product was correct, but the inner trays were labeled as 4824PL-20 instead of 4826PL-20.
Distribution: US Nationwide distribution in the states of MA, MD, MO and IN.
Initiated: Voluntary: Firm initiated
Recall number: Z-1820-2020

Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product Usage: Portex lumbar puncture trays provide all the materials necessary to measure cerebrospinal fluid pressure and/or collect cerebrospinal flu

Terminated Class II Medical devices

Recall started: 7 January 2020
Terminated: 14 December 2020
Reason: Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.
Distribution: USA: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI,MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA. Int'l: CA, DE, AU.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1716-2020, Z-1715-2020

Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes

Terminated Class I Medical devices

Recall started: 28 October 2019
Terminated: 6 June 2024
Reason: There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm functionality, and interruption of therapy.
Distribution: CO, MD, NY
Initiated: Voluntary: Firm initiated
Recall number: Z-0610-2020

Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

Terminated Class II Medical devices

Recall started: 8 July 2019
Terminated: 23 August 2020
Reason: Potential for certain GRIPPER Needles to contain an occluded or blocked needle.
Distribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR. International distribution
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0189-2020, Z-0190-2020

GRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL, GRIPPER, 22G X 1.25" (32MM), 12/BX; 3. NDL, GRIPPER, 20G X 1.25" (32MM), 12/
GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 2. TRAY, PAC, VEN LP, TI, PU, 1.9MM, UL

Terminated Class II Medical devices

Recall started: 11 February 2019
Terminated: 2 November 2020
Reason: Packaged with an incorrect size inner cannula.
Distribution: Worldwide Distribution - US Nationwide AL, CA, CT, FL, IL, KY, MA, MD, NC, NJ, OH, OR, PA, RI, SC, TN, UT, and VA. Canada, UK and Ireland
Initiated: Voluntary: Firm initiated
Recall number: Z-1732-2019

Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra¿ Tracheostomy Tubes are indicated for airway maintenanc

Terminated Class II Medical devices

Recall started: 11 February 2019
Terminated: 23 June 2020
Reason: Incorrect needle length and gage.
Distribution: US Nationwide Distribution - AZ, CA, FL, GA, IL, IN, MA, MN, MO, MS, NJ, NY, PA, RI, SC, TN, TX, VA, and WA.
Initiated: Voluntary: Firm initiated
Recall number: Z-1733-2019

Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device intended for injection or aspiration of fluids using a Luer lock or Luer sl

Terminated Class II Medical devices

Recall started: 26 November 2018
Terminated: 13 May 2021
Reason: Certain lots of the Model 306701 ProtectIV¿ Plus Safety IV Catheter may exhibit damage on the safety mechanism guard.
Distribution: United States - AK, AZ, FL, GA, IL, IN, KS, LA, MD, MN, MS, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA. One foeign consignee in Costa Rica
Initiated: Voluntary: Firm initiated
Recall number: Z-0352-2020

ProtectIV¿ Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton.

Terminated Class II Medical devices

Recall started: 19 November 2018
Terminated: 5 June 2020
Reason: Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that may result in a leak. Model Number - Lot Number MX4301L - 3538569 MX4331L - 3562377 & 3546826 MX4331R - 3546924
Distribution: The potentially affected products were shipped to customers in the US, Canada, and Mexico.
Initiated: Voluntary: Firm initiated
Recall number: Z-0512-2019

Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.

Terminated Class II Medical devices

Recall started: 15 October 2018
Terminated: 11 October 2022
Reason: Customers who utilize PharmGuard¿ Server Software (PGS) with Medfusion¿ 4000 pumps manufactured prior to November 10, 2017, may experience wireless network connectivity issues on certain pumps due to a potential Radio Module issue on some Medfusion¿ 4000 pumps.
Distribution: Worldwide distribution - Nationwide in the states of AL, AR, AZ, CA, CN, CO, CT, DC, FL, GA, ID, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV and country of Canada.
Initiated: Voluntary: Firm initiated
Recall number: Z-2554-2019

Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1,

Terminated Class II Medical devices

Recall started: 22 August 2018
Terminated: 11 February 2021
Reason: Several lots of Jelco¿ ViaValve" safety intravenous (I.V.) catheters exhibited a V shaped puncture at the base of the catheter near the hub due to an adjustment that was made in the manufacturing process.
Distribution: Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, and New Zealand.
Initiated: Voluntary: Firm initiated
Recall number: Z-1218-2019

Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The Jelco(R) ViaValve(TM) safety I.V. catheter is a sterile, non pyrogenic, single use, radiopaque intravascular

Terminated Class III Medical devices

Recall started: 13 July 2018
Terminated: 19 October 2018
Reason: The product was mislabeled with the incorrect label.
Distribution: US Nationwide Distribution in the states of CT, MA, MI, NC, NJ, NY, RI, TX, UT, and WA.
Initiated: Voluntary: Firm initiated
Recall number: Z-3196-2018

Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.

Terminated Class III Medical devices

Recall started: 6 July 2018
Terminated: 30 April 2019
Reason: "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
Distribution: Worldwide Distribution - US Nationwide in the states of AR, CA, GA, IN, LA, OK, MA, MI, NC, NJ, NV, SC, TX, VA, and WV. There was government distribution and no military distribution. Foreign distribution was made to Poland and Russia.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0073-2019, Z-0071-2019, Z-0075-2019, Z-0072-2019, Z-0074-2019

smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. Product Usage: For the administration of
smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
smiths medical portex First Breath Nasal Oxygen Cannula, REF 001292, with Gas Monitoring Line, 305 cm (10ft.) & Male Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. Product Usage: For the administration of

Terminated Class II Medical devices

Recall started: 22 June 2018
Terminated: 5 October 2020
Reason: The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 36-month expiration dating.
Distribution: Distribution was nationwide, including Puerto Rico. There was also military/government distribution. Foreign distribution was made to Canada, United Arab Emirates, Bahamas, Costa Rica, Latvia, and Saudi Arabia.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0842-2019, Z-0843-2019

Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, models 4589P-1, 4591EG-1, 4591P-1, 4599P-1, 4611LH, 4611P-1, 4620EG-1, 4
Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-1, 4039-1, 4039EG-1, 4044EG-1, 4044P-1, 4057NP-1, 4067NP-1, 4077EG-1, 4077NP-1, 408

Terminated Class II Medical devices

Recall started: 10 May 2018
Terminated: 15 September 2023
Reason: Product has a lack of sterility assurance
Distribution: International Distribution to countries of: Armenia, Austria, Germany, Great Britain, Hungary, Italy, New Zealand, Poland, Slovenia, Spain, Sweden, and Switzerland.
Initiated: Voluntary: Firm initiated
Recall number: Z-0155-2022

medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE g. 089-101E h. 888-101NE i. 081-102GEE j. 888-101BE k. 888-101GE l. 888

Terminated Class II Medical devices

Recall started: 13 April 2018
Terminated: 30 January 2023
Reason: Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or the pump, misidentifying the size of a loaded syringe.
Distribution: US distribution to AL, AZ, CA, DC, FL, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, WA. International distribution to Canada and Lebanon.
Initiated: Voluntary: Firm initiated
Recall number: Z-2662-2018

Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism

Terminated Class II Medical devices

Recall started: 2 April 2018
Terminated: 14 November 2018
Reason: Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
Distribution: Domestic distribution to CA, FL, GA, ID, NJ, NM, OH, VA. International distribution to France.
Initiated: Voluntary: Firm initiated
Recall number: Z-2114-2018

Bivona¿ Tracheostomy Tube Tracheostomy Tubes

Terminated Class II Medical devices

Recall started: 4 December 2017
Terminated: 12 June 2020
Reason: Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kits may incorrectly contain a 6Fr or 6.5Fr size introducer instead of the correct 8.5Fr size introducer. The Power PORT A CATH II kit may also contain the incorrect locking collars in addition to the incorrect sized introducer.
Distribution: Worldwide Distribution. US nationwide including Puerto Rico, Austria, Bahamas, Belgium, Dominican Republic, Netherlands, Spain, and Turks and Caicos.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1073-2018, Z-1074-2018

PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA); c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO (1/EA)
Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/E

Terminated Class II Medical devices

Recall started: 29 November 2017
Terminated: 11 July 2018
Reason: Some printing modes on the devices may not function properly (tabular data printing, real-time continuous printouts, and automatic interrupt print feature).
Distribution: Worldwide Distribution - US Nationwide in the states of CO and MT. Foreign distribution was to Armenia.
Initiated: Voluntary: Firm initiated
Recall number: Z-2379-2018

BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the reorder numbers have to do with certain functions being installed or not installed.)

Terminated Class II Medical devices

Recall started: 22 November 2017
Terminated: 25 September 2020
Reason: Certain CADD Legacy 1, Ambulatory Infusion Pumps, may contain non-matching serial numbers. The label attached to the back of the pump may list a serial number that does not match the correct serial number programmed into the software of the pump.
Distribution: US, Australia
Initiated: Voluntary: Firm initiated
Recall number: Z-0307-2018

CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY

Terminated Class II Medical devices

Recall started: 13 November 2017
Terminated: 16 September 2025
Reason: Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. The inability of a pump to recognize a syringe (i.e. the size of the syringe is unknown to the pump) results in an inability to complete pump programming. Misidentification of a syringe is where the pump misinterprets the syringe size.
Distribution: Worldwide distribution- US nationwide Distribution and to the countries of : Australia, Barbados, Canada, Hong Kong, Indonesia, Jamaica, New Zealand, Philippines, Saudi Arabia, Singapore, South Africa, Trinidad and Tobago, United Arab Emirates, and United Kingdom.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1136-2018, Z-1135-2018, Z-1134-2018

Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood product
Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood product
Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood product

Terminated Class II Medical devices

Recall started: 24 August 2017
Terminated: 1 May 2020
Reason: In certain cases, the lock and key supplied with Graseby 3300 pumps and accessories does not match the standard Graseby 3300 key.
Distribution: Worldwide Distribution to the countries of : Australia, Canada, Germany, France, Great Britain, Hong Kong, and Ireland
Initiated: Voluntary: Firm initiated
Recall number: Z-0497-2018

Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion

Terminated Class II Medical devices

Recall started: 22 August 2017
Terminated: 14 April 2025
Reason: Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate the "Invalid Syringe Size" alarm.
Distribution: Worldwide Distribution: US (Nationwide) and countries of: Canada, Great Britain, Panama, Germany, India, Philippines, and Oman.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0313-2018, Z-0314-2018

Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring pr
Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring

Terminated Class II Medical devices

Recall started: 15 July 2016
Terminated: 24 April 2020
Reason: Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.
Distribution: International Distribution to:Germany
Initiated: Voluntary: Firm initiated
Recall number: Z-0577-2018

Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.

Ongoing Class II Medical devices

Recall started: 3 December 2015
Reason: There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period. These alarms occur at start up when the pump goes through the self-test. This recall occurred in 2015.
Distribution: Distribution US nationwide, including PR, VI, GU, and MP. There was government/military/foreign distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-0653-2022

Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main board part numbers G

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.