Plainsboro, NJ, United States
Integra LifeSciences Corp. recalls
36 recalls recorded since 2018, most recently on 6 February 2025. 19 are listed as ongoing. Status and classification are as published by the FDA.
Recalls36
Ongoing (FDA)19
Terminated or completed17
Class I (FDA)3
Ongoing Class II Medical devices
- Recall started
- 6 February 2025
- Reason
- Possibility for the obturator to break (separate).
- Distribution
- US Nationwide distribution in the states of MO, FL, TX, NY, IL, OH, NJ, CA, MN, WA, TN, MD, LA, OK, SC, PA, MI, KY, NC, DC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1295-2025
- AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80
Ongoing Class II Medical devices
- Recall started
- 10 January 2025
- Reason
- Potential that the induction seal is not completely sealed to the device tube packaging.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and WY and the Virgin Islands and the country of Malaysia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1168-2025
- Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney¿ Gel with Active Leptospermum Honey is a moist dressing m
Ongoing Class II Medical devices
- Recall started
- 16 December 2024
- Reason
- Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
- Distribution
- US Nationwide distribution in the states of FL, NC, MA, MN, OH, DC, VA, CA, WI, NE, TX, NY, MI, OR, NJ, SC, AZ, UT, RI, IN, GA, CO and the countries of Canada, Australia, New Zealand, Cyprus, Sweden, Finland, Slovenia and Great Britain.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0977-2025, Z-0979-2025, Z-0978-2025
- CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
- CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
- CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Ongoing Class II Medical devices
- Recall started
- 26 September 2024
- Reason
- Out of specification endotoxin levels.
- Distribution
- China
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0262-2025
- Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Ongoing Class II Medical devices
- Recall started
- 20 September 2024
- Reason
- Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
- Distribution
- Worldwide Distribution. US Nationwide, Canada Germany United Kingdom of Great Britain and Northern Ireland (the) Malta Italy Barbados Trinidad and Tobago Australia New Zealand Netherlands (the) Belgium France Ireland Switzerland Brunei Darussalam Bahamas (the) South Africa China Ecuador Korea (th
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0244-2025, Z-0253-2025, Z-0247-2025, Z-0246-2025, Z-0243-2025, Z-0240-2025, Z-0238-2025, Z-0250-2025, Z-0248-2025, Z-0239-2025, Z-0251-2025, Z-0254-2025 and 10 more
- SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surg
- SURG STRP 1-1/2X6 Model/Catalog Number: 801454. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surger
- SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surger
- SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery
- SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during
- SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during su
- SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during su
- SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
- and 14 more product lines
Ongoing Class II Medical devices
- Recall started
- 13 September 2024
- Reason
- There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
- Distribution
- Worldwide - US Nationwide distribution in the states of MN, IL, UT, FL, NC, CA, MO, IN, MS, OH, PA, TX, HI, MA, WA, GA, AZ, VA, NY, CO, MI, OK, NV, NJ, SC, OR, VT, DC, WI, TN, WV, KS, AL, NE, MD, ID, LA, AR, KY, IA, AK, NM, ME, RI and the countries of Madagascar, Malaysia, Guam.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0054-2025
- MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535)
Ongoing Class II Medical devices
- Recall started
- 9 July 2024
- Reason
- Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in a discrepancy between the actual tip location and the visualized location displayed on the system.
- Distribution
- The devices are only sold in the US. The following states have received the product: AL, AZ CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, PA, SC, SD, TN, TX, VA, VT, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2507-2024
- TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in ENT medicine and skull base surgery
Ongoing Class II Medical devices
- Recall started
- 7 June 2024
- Reason
- Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
- Distribution
- Domestic: NY, OH, & DC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2331-2024
- AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Ongoing Class II Medical devices
- Recall started
- 29 May 2024
- Reason
- Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment
- Distribution
- Nationwide Foreign: Argentina Australia Bangladesh Bangladesh Belgium Bolivia (Plurinational State of) Brazil Canada Chile China Costa Rica Dominican Republic (the) El Salvador Hong Kong India Indonesia Japan Korea (the Republic of) Malaysia Mexico Mongolia Myanmar Nepal New Zealand Pakistan Panama
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2167-2024
- CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue Catalog Number: C2600* *Note: you may see C2600P or C2600SR
Ongoing Class II Medical devices
- Recall started
- 7 May 2024
- Reason
- Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.
- Distribution
- Worldwide - US Nationwide distribution in the state of TX and the countries of Canada, China, Croatia, Hungary, Russia, Singapore, Slovenia, South Africa, Taiwan (Province of China), Turkey
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2136-2024, Z-2138-2024, Z-2137-2024
- CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar ph
- CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and ot
- CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of s
Ongoing Class II Medical devices
- Recall started
- 17 April 2024
- Reason
- Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
- Distribution
- Worldwide distribution - US Nationwide and the countries of CA, BE, CL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1873-2024
- Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Ongoing Class II Medical devices
- Recall started
- 19 January 2024
- Reason
- A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Bahamas, Belgium, Canada, Chile, France, Germany, Greece, Ireland, Israel, Poland, Portugal, Slovenia, South Africa, Spain, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the).
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1196-2024, Z-1194-2024, Z-1198-2024, Z-1199-2024, Z-1197-2024, Z-1193-2024, Z-1200-2024, Z-1202-2024, Z-1195-2024, Z-1201-2024, Z-1203-2024
- Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.
- Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
- Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
- Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
- Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
- Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the brain.
- INS7280 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
- Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.
- and 3 more product lines
Ongoing Class II Medical devices
- Recall started
- 19 October 2023
- Reason
- Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0493-2024, Z-0491-2024, Z-0498-2024, Z-0497-2024, Z-0492-2024, Z-0495-2024, Z-0496-2024, Z-0494-2024, Z-0499-2024
- Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
- Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND
- Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04
- Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP06
- Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7270
- Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7260
- Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7250
- Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7280
- and 1 more product lines
Ongoing Class I Medical devices
- Recall started
- 5 October 2023
- Reason
- Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective action includes a design change to the extension cable to address the "out of range readings" issue.
- Distribution
- US distribution nationwide to the following states: AL AR AZ CA CO CT DC DE FL GA IA KY LA MA ME MN ND NE NH NJ NY OK PA RI TN TX UT VA WI WV OUS distribution to Australia/New Zealand, Canada, and Europe/Middle East/Africa.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0548-2024
- CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part of the same SKU.
Ongoing Class II Medical devices
- Recall started
- 11 April 2023
- Reason
- Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result in inflammation, local toxicity, systemic toxicity, sensitivity, revision surgery, procedural delay, inconvenience to user, and/or infection.
- Distribution
- PA Foreign: Australia, Belgium
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1614-2023
- Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage device. Part Number: 82-6607
Ongoing Class II Medical devices
- Recall started
- 2 December 2022
- Reason
- Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, CO, CT, FL, IN, KY, MA, MI, MO, NC, NJ, NY, OH, PA, TX, VA, WV and the countries of Chile, Australia, New Zealand, France, Romania, United Kingdom, and Ireland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0909-2023
- Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Ongoing Class I Medical devices
- Recall started
- 22 June 2022
- Reason
- Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor or extension cable failure!" The firm has found that this is caused by electrical interference from a component of the monitor's circuit board and from the environment.
- Distribution
- Worldwide Distribution: US nationwide, Australia, New Zealand, Canada, Hong Kong, Pakistan, Georgia, Saudi Arabia, Israel, South Africa, United Arab Emirates, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Latvia, Lithuania, Nethe
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1395-2022
- CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
Ongoing Class II Medical devices
- Recall started
- 28 February 2022
- Reason
- Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition.
- Distribution
- US Nationwide Distribution: AL, AZ, FL, GA, IL, MA, MD, NY, OH, OR, PA, TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0906-2022
- Integra Universal Flexible Arm part number REF 1362275
Terminated Class II Medical devices
- Recall started
- 21 January 2022
- Terminated
- 19 March 2024
- Reason
- Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur
- Distribution
- Worldwide distribution - US Nationwide and the country of Hong Kong.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0818-2022, Z-0817-2022
- Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage procedures. Part Number: 826616
- Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage procedures. Product umber: 826614
Terminated Class II Medical devices
- Recall started
- 1 June 2021
- Terminated
- 27 January 2023
- Reason
- Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier
- Distribution
- US Nationwide Distribution - Foreign Distribution: Hong Kong
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2224-2021
- CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037
Terminated Class II Medical devices
- Recall started
- 17 March 2021
- Terminated
- 2 December 2021
- Reason
- Incorrect labeling, Catheter did not have the required holes and markings
- Distribution
- CA CO FL KY MD NC NC NY NY TX WI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1354-2021
- CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus. Catalog Number: NS5524
Terminated Class II Medical devices
- Recall started
- 14 December 2020
- Terminated
- 19 July 2021
- Reason
- Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0724-2021, Z-0725-2021
- Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting cerebrospinal fluid (CSF) Part Number: 82307
- Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. Part Number: 823087
Terminated Class II Medical devices
- Recall started
- 11 November 2020
- Terminated
- 17 June 2021
- Reason
- Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, China, HONG KONG, HK, India, Shri Lanka, Mexico, Philippines, Trinidad.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0548-2021
- Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000
Terminated Class II Medical devices
- Recall started
- 4 August 2020
- Terminated
- 12 August 2021
- Reason
- lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of MN, TX, CA, UT, WV, FL, IN, GA, AZ, and the countries of Latin America ( CR, MX, TT, EC, PA ), Canada, Europe (FR, AT, BE, ES).
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2954-2020, Z-2953-2020, Z-2955-2020
- Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals an
- 13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. T
- Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hos
Terminated Class III Medical devices
- Recall started
- 7 February 2020
- Terminated
- 10 June 2020
- Reason
- Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, IN, LA, MI, MN, MO, NC, NM, NY, PA, SC, and TX and countries of Italy, France, Germany, and Finland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1470-2020
- NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the
Terminated Class II Medical devices
- Recall started
- 21 October 2019
- Terminated
- 7 May 2020
- Reason
- The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
- Distribution
- US: AL AR AZ CA CO CT FL GA IA ID IL IN KS KY LA MA MD MI MN MO MS NC NE NJ NY OH OK OR PA SC TN UT VA WA WI WV International: SG MX CA JP AU CO TH HK
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0637-2020, Z-0616-2020, Z-0640-2020, Z-0644-2020, Z-0629-2020, Z-0614-2020, Z-0641-2020, Z-0613-2020, Z-0634-2020, Z-0652-2020, Z-0615-2020, Z-0631-2020 and 30 more
- C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- and 34 more product lines
Ongoing Class II Medical devices
- Recall started
- 12 September 2019
- Reason
- There is a potential for a progressive decline in observed ICP readings of the monitor during use.
- Distribution
- The products were distributed to the following US states: CA, CO, CT, FL, IN, NY, OK, PA, TX, WI, and WV. The products were distributed to the following foreign countries: Australia, Belgium.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0124-2020
- Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems.
Terminated Class II Medical devices
- Recall started
- 7 August 2019
- Terminated
- 24 June 2020
- Reason
- A small crack at the box lock corner may after multiple cleaning and sterilization cycles produce an increased risk of corrosion, weakening the instrument and resulting in premature need for replacement and/or breakage of the instrument
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2435-2019
- Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332
Terminated Class II Medical devices
- Recall started
- 19 July 2019
- Terminated
- 22 May 2020
- Reason
- Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected
- Distribution
- KY,NJ, RI, TX, WA Foreign: BE
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2206-2019
- Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial / plastic surgery procedur
Terminated Class I Medical devices
- Recall started
- 8 April 2019
- Terminated
- 27 January 2021
- Reason
- The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.
- Distribution
- Worldwide Distribution - US Nationwide International distribution to Argentina, American Samoa, Australia, Canada, and Guam.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1311-2019, Z-1312-2019, Z-1310-2019
- MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage: The MoniTorr ICP External CSF Drainage and Monitoring Systems provide a simple to use, closed system for the drainage of cerebr
- LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS9020SP1 INS-9020SP1 LIMITORR VOLUME EVD 20ML LimiTorr INS9030 INS-9030 LIMITORR VOLUME LIMITING EVD 30 ML LimiTorr INS9030SP1 INS-9030SP1 LIMITO
- MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniTorr 10102 10-102 CSF Drainage System w/Patient Line One Way Valve w MoniTorr 10110 10-110 CSF Drainage System used with Pole Mount System Mon
Terminated Class II Medical devices
- Recall started
- 8 March 2019
- Terminated
- 15 May 2020
- Reason
- The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- Distribution
- Distributors in AL, CA, CT, FL, GA, HI, IA, ID, KS, KY, MD, MI, MO, MT, NC, NE, NJ, NM, NY, OH, OK,PA, TX, VA, WA, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1167-2019, Z-1154-2019, Z-1173-2019, Z-1157-2019, Z-1172-2019, Z-1152-2019, Z-1174-2019, Z-1160-2019, Z-1155-2019, Z-1162-2019, Z-1170-2019, Z-1171-2019 and 14 more
- Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T
- Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Left, Part No. LJU210T
- Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T
- Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left, Part No. LJU213T
- Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T
- Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, Part No. LJU202T
- Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T
- Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T
- and 18 more product lines
Terminated Class II Medical devices
- Recall started
- 29 June 2018
- Terminated
- 26 February 2020
- Reason
- There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
- Distribution
- Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV; and to countries of:: Australia, Canada, China, Dominican Re
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2595-2018, Z-2592-2018, Z-2594-2018, Z-2593-2018
- MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid sup
- MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support betwe
- MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid
- MAYFIELD Infinity XR2 Base Unit-Extended, Part Number A2079E The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid sup
Terminated Class II Medical devices
- Recall started
- 6 March 2018
- Terminated
- 30 July 2018
- Reason
- Incorrect gel part number listed in a master manufacturing record
- Distribution
- US state of RI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1630-2018
- Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lacerations and mino
Terminated Class II Medical devices
- Recall started
- 20 December 2017
- Terminated
- 24 February 2020
- Reason
- Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral stem trial whiling preparing the humeral canal and/or trialing. All cases resulted in a delay in surgery, with a variance of medical intervention required.
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1463-2018
- The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product Description TRL092002506 Humeral Stem Trial, 6mm TRL092002507 Humeral Stem Trial,
Terminated Class II Medical devices
- Recall started
- 26 September 2017
- Terminated
- 14 August 2018
- Reason
- A faulty footswitch may result in unintended ultrasonic fragmentation activation. There are two scenarios when the failure mode may occur: 1) Ultrasonic fragmentation may be inadvertently activated at start-up or at the initial use once the footswitch is connected to the console and after the user primes the system, performs a handpiece test, and enters the Main Screen. 2) Ultrasonic fragmentation may remain activated during surgical use once the foot pedal is disengaged slowly.
- Distribution
- Worldwide Distribution - US Nationwide in 33 states: AL, AR, CA, CO, CT, FL, GA, IA, ID, IL, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NM, NY, OH, OK, OR, PA, TN, TX, VA, WA, WI in the countries of Greece, South Africa, France, Germany, Italy, United Kingdom, Sweden, Netherlands, and Dominican
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0694-2018
- Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 Product Usage: The footswitch is a component of the CUSA Clarity Ultrasonic Surgical Aspirator System, which is indicate
Terminated Class II Medical devices
- Recall started
- 18 August 2017
- Terminated
- 19 July 2018
- Reason
- A quarantined lot of the devices was released for sale. Devices from this lot may experience increased exothermic reaction causing higher levels of heat output which exceed the product specifications.
- Distribution
- US nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1487-2018
- TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
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.