Morrisville, NC, United States
Teleflex Medical recalls
26 recalls recorded since 2018, most recently on 11 April 2022. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls26
Ongoing (FDA)4
Terminated or completed22
Class I (FDA)5
Ongoing Class II Medical devices
- Recall started
- 11 April 2022
- Reason
- Reports received of torn corrugated breathing tubes.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The countries of Austria, Australia, Belgium, Canada, Chile, Czech Republic, Finland, F
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1126-2022, Z-1127-2022
- (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-sterile; (3) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19061, sterile; (4) Gib
- (1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, sterile; (3) Teleflex Smooth-Flo Flex with Double Swivel, Product #22512, non-sterile; (4) Teleflex Smo
Terminated Class I Medical devices
- Recall started
- 11 January 2022
- Terminated
- 11 September 2024
- Reason
- The firm received reports indicating PTD tip separation during use.
- Distribution
- Worldwide distribution: US Nationwide and the countries of AU, BE, CA, CL, CZ, DE, ES, FR, GB, IL, IT, KR, KW, NL, PA, PH, PT, SA, TR.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0625-2022, Z-0626-2022, Z-0628-2022, Z-0629-2022, Z-0627-2022, Z-0624-2022, Z-0623-2022
- Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arr
- Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65709-HS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter,
- 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative) The Arrow-Trerotol
- Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, perm
- Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow R
- Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter
- Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conju
Terminated Class II Medical devices
- Recall started
- 18 February 2021
- Terminated
- 31 August 2026
- Reason
- Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the hinge.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI. The country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1294-2021
- RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Terminated Class II Medical devices
- Recall started
- 12 February 2021
- Terminated
- 10 July 2026
- Reason
- Teleflex is recalling this product due to a lack of assurance of sterility.
- Distribution
- US Nationwide distribution in the states of IL, PA, FL, NJ, CT, NY, TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1298-2021
- PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from the mediastinum and/or the pleural space. The thoracic catheter is comp
Terminated Class II Medical devices
- Recall started
- 7 August 2020
- Terminated
- 14 January 2023
- Reason
- Potential sterility issue
- Distribution
- US Distribution of states to: AR AZ CA CO FL GA IA IL IN LA MI MN MS NC NH NV NY OH OK OR PA SD TN TX VA WA WI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2922-2020
- Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any surgical procedure requiring attachment to a Chest Drainage device. The thoracic catheter is indicated for use l
Terminated Class II Medical devices
- Recall started
- 6 July 2020
- Terminated
- 31 August 2023
- Reason
- Breaking at the point of a welded joint
- Distribution
- US Nationwide distribution including in the states of FL, KY, CA, ND, UT, MA, MD, AZ, MS, TX, MI, WV, AL, MO, SC, VA, AR, PA, OK, NV, NM, NE, IN, IA, NY, GA, NJ, MN, IL, NC, NH, TN, ID, CO, HI, MT, OR, ME, CT, LA, OH, RI, SD, WA, DC, KS, AK.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2726-2020, Z-2731-2020, Z-2727-2020, Z-2732-2020, Z-2730-2020, Z-2729-2020, Z-2728-2020
- Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubatio
- Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubatio
- Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubati
- Rusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
- Rusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubatio
- Rusch Greenlite Product Code: 004551002 GTIN: 14026704663115 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubatio
- Rusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubatio
Terminated Class II Medical devices
- Recall started
- 30 June 2020
- Terminated
- 2 July 2026
- Reason
- Potential for sterile packaging to be compromised¿
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of FL, PR and the countries of AL, BR, CR, EC, ES, GB, GR, HK, HN, ID, IT, MX, PA, PE, PH, PK, PR, SG, SV, VE.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2749-2020, Z-2748-2020
- Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid from re-accumulating
- Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid from re-accumulating in th
Terminated Class II Medical devices
- Recall started
- 29 May 2020
- Terminated
- 17 June 2025
- Reason
- Teleflex is initiating a voluntary recall for the above-mentioned products due to reports indicating that the laser guard foil partially separated and/or slightly detached at the edges in the presence of moisture.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2533-2020
- RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code 102004-000050 c) I.D. mm 6,0, Product Code 102004-000060 d) I.D. mm 7,0, Product Code 102004-000070
Terminated Class II Medical devices
- Recall started
- 13 January 2020
- Terminated
- 24 November 2021
- Reason
- There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1269-2020, Z-1270-2020
- Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
- Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm, REF DP-28K b) 3.6 mm, REF DP-36K c) 4.0 mm, REF DP-40K d) 4.4 mm, REF DP-44K e) 4.8 mm, REF DP-48K f) 5.2 mm, REF DP-52K g) 5.6 mm, REF
Terminated Class II Medical devices
- Recall started
- 9 January 2020
- Terminated
- 11 September 2023
- Reason
- The products are being recalled due to reports of breakage broke at the point of a welded joint either prior to use during setup or during use inside the patient's mouth.
- Distribution
- Distributed nationwide in the US and to Puerto Rico; OUS to more than 20 countries; To the following government VA medical Centers: VAMC - KANSAS CITY MO 4801 E Linwood Blvd Kansas City MO 64128-2218
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1117-2020, Z-1116-2020
- Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
- Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
Terminated Class I Medical devices
- Recall started
- 13 December 2019
- Terminated
- 30 April 2024
- Reason
- There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.
- Distribution
- nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1114-2020, Z-1112-2020, Z-1115-2020, Z-1113-2020
- HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit
- HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit
- HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414, humidifier nebulizer kit
- HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port, REF 2416, humidifier nebulizer kit
Terminated Class II Medical devices
- Recall started
- 30 October 2019
- Terminated
- 30 September 2021
- Reason
- The tracheal and brochial swivel connectors are incorrectly labeled.
- Distribution
- US Nationwide distribution in the states of CT, OK, LA, IL, GA, NY, CA, MT, MI, MA, FL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0703-2020
- HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are intended for use in Thoracic surgery, brochospirometry, adminitration of endobronchial anesthesia and
Ongoing Class II Medical devices
- Recall started
- 11 October 2019
- Reason
- Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging problem that may affect certain batches of the SPROTTE lumbar puncture cannulas with introducer. Due to this problem Pajunk cannot guarantee the sterility of the affected batches.
- Distribution
- Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2129-2020, Z-2130-2020
- Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including ane
- Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including ane
Ongoing Class II Medical devices
- Recall started
- 8 October 2019
- Reason
- The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not detected, the immediate risk of exposure to the affected devices is needle stick injury to the clinician or health care professional. In addition, a puncture of the packaging may compromise the sterility of the needle.
- Distribution
- US nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0689-2020, Z-0690-2020, Z-0688-2020
- Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code 9001P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal hume
- Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, Product Code 9079P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal hume
- Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, Product Code 9018P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal hume
Ongoing Class II Medical devices
- Recall started
- 4 October 2019
- Reason
- Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, or the jaws becoming locked in a partially closed position (jammed).
- Distribution
- Worldwide distribution, including US nationwide (including Puerto Rico).
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0497-2020, Z-0496-2020
- WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips
- WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips
Terminated Class I Medical devices
- Recall started
- 30 July 2019
- Terminated
- 15 February 2022
- Reason
- Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2313-2019, Z-2316-2019, Z-2312-2019, Z-2314-2019, Z-2315-2019, Z-2311-2019, Z-2318-2019, Z-2317-2019
- Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm, REF 5-22514 d) 7.5 mm, REF 5-22515 e) 8.0 mm, REF 5-22516 f) 8.5 mm, REF 5-22517 g) 9.0 mm, REF 5-22518 h) 6.0 mm, REF 5-22512
- Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10312 d) 6.5 mm, REF 5-10313 e) 7.0 mm, REF 5-10314 f) 7.5 mm, REF 5-10315 g) 8.0 mm, REF 5-10316 h) 8.5 mm, REF 5-10317 i)
- Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, REF 5-10109 e) 5.0 mm, REF 5-10110, REF 5-10210 f) 5.5 mm, REF 5-10111 g) 6.0 mm,
- Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, REF 5-22107 c) 4.0 mm, REF 5-22008, REF 5-22108, REF 5-22208 d) 4.5 mm, REF 5-22009, REF 5-22109, REF 5-22209 e) 5.0 mm, REF
- Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm, REF 5-10406 d) 3.5 mm, REF 5-10407 e) 4.0 mm, REF 5-10408 f) 4.5 mm, REF 5-10409 g) 5.0 mm, REF 5-10410 h) 5.5 mm, REF 5-10
- Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tube/airway management
- Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF V5-10316 d) 8.5 mm, REF V5-10317 Product Usage: Tracheal tube/airway management
- Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management
Terminated Class II Medical devices
- Recall started
- 1 July 2019
- Terminated
- 4 November 2021
- Reason
- Potential for product not to be sterile.
- Distribution
- Nationwide distribution to CA, FL, IL, NC, NJ, OH, OK, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2086-2019
Terminated Class I Medical devices
- Recall started
- 24 May 2019
- Terminated
- 15 February 2022
- Reason
- This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.
- Distribution
- Worldwide - US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1761-2019, Z-1760-2019, Z-1764-2019, Z-1765-2019, Z-1759-2019, Z-1766-2019, Z-1762-2019, Z-1763-2019
- Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product Code 5-22513 3) EZ-ENDO 7.0 mm, Product Code 5-22514 4) EZ-ENDO 7.5 mm, Product Code 5-22515 5) EZ-ENDO 8.0 mm, Product Code 5-
- Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Product Codes: 5-10114, 5-10214 4) CF 7.5 mm, Product Codes: V5-10115, 5-10115, 5-102
- Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code 5-10313 3) HVT 7.0 mm, Product Code 5-10314 4) HVT 7.5 mm, Product Code 5-10315 5) HVT 8.0 mm, Product Code 5-10316 6) HVT 8.5 mm
- Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway management
- Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management
- Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code V5-10315 3) Novaplus 8.0 mm, Product Code V5-10316 4) Novaplus 8.5 mm, Product Code V5-10317 Product Usage: Tracheal tube/a
- Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c) 5-22112, d) 5-22012, 2) Preformed 6.5 mm, Product Codes: a) 5-22313, b) 5-22213, c) 5-22013, d) 5-22113, 3) Pr
- Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm, Product Code 5-10413 3) Uncuffed 7.0 mm, Product Code 5-10414 Product Usage: Tracheal tube/airway management
Terminated Class I Medical devices
- Recall started
- 10 May 2019
- Terminated
- 22 April 2024
- Reason
- Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.
- Distribution
- US Nationwide Distribution in the states of AL, TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1912-2019
- Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column: a) REF 870-07KIT b) REF 870-09KIT Product Usage: The Neonatal ConchaSmart breathing circuits are intended t
Terminated Class II Medical devices
- Recall started
- 1 April 2019
- Terminated
- 3 June 2025
- Reason
- The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1683-2019, Z-1682-2019, Z-1684-2019, Z-1686-2019, Z-1685-2019
- RUSCH LASERTUBE (Rubber), Order No. : 102004-000050, REF 102004, SIZE I.D. mm 5,0
- RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0
- RUSCH LASERTUBE (Rubber), Order No. : 102004-000060, REF 102004, SIZE I.D. mm 6,0
- RUSCH LASERTUBE (Rubber), Order No. : 102004-000080, REF 102004, SIZE I.D. mm 8,0
- RUSCH LASERTUBE (Rubber), Order No. : 102004-000070, REF 102004, SIZE I.D. mm 7,0
Terminated Class III Medical devices
- Recall started
- 27 February 2019
- Terminated
- 6 September 2023
- Reason
- The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an alternative to incontinence pads. In normal use, the device is neither expected nor required to be sterile.
- Distribution
- ME,NC, WA, MO, NJ, FL, CAL, TX, OH, IL, MA, GA, FL, GA, Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0796-2020, Z-0797-2020
- Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500
- Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M
Terminated Class III Medical devices
- Recall started
- 14 January 2019
- Terminated
- 13 December 2022
- Reason
- The device labels are not UDI compliant. The missing UDI compliance information on the labelling would not affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1975-2019, Z-1974-2019
- RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
- RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
Terminated Class II Medical devices
- Recall started
- 7 January 2019
- Terminated
- 4 November 2021
- Reason
- The internal tip is missing from the device, causing the device to not function as intended.
- Distribution
- TX, NY, DC and Philippines
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0846-2019
- Pilling COOLEY SUMP-SUCTION TUBE, REF 351547
Terminated Class II Medical devices
- Recall started
- 15 February 2018
- Terminated
- 31 October 2018
- Reason
- Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. The 6 individually packaged units within the boxes are correctly labeled.
- Distribution
- KS
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1193-2018
- Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.
Terminated Class II Medical devices
- Recall started
- 3 January 2018
- Terminated
- 30 October 2020
- Reason
- There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and security of the tool tip. Should this occur during use, surgical intervention may be required.
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, China, Czech Republic, France, Germany, Great Britain, Iran, Ireland, Italy, Japan, Lebanon, Netherlands, Qatar, Romania, Saudi Arabia, Singapore, Spain, Taiwan, Turkey, and the United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0754-2019, Z-0753-2019
- Percuvance(R) Percutaneous Shaft 36cm, PCVSHL3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended Use: soft tissue to access certain areas of the abdomen. The system
- Percuvance(R) Percutaneous Shaft 29cm, PCVSH3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended Use: soft tissue to access certain areas of the abdomen. The system
Terminated Class II Medical devices
- Recall started
- 10 January 2017
- Terminated
- 13 April 2021
- Reason
- The pouch may contain the incorrect Rusch Green Lite product size. Pouches that are labeled as containing RUSCH GREEN LITE MAC 1 may instead contain RUSCH GREEN LITE MAC 2.
- Distribution
- US only
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0705-2018
- Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation.
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.