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Browse Device Recalls

249 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 249 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 249 FDA device recalls.

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DateProductReasonClassFirm
Sep 20, 2024 SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and ... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 13, 2024 MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/A... There is a potential for pinholes in the applicator pouch film which creates a sterility concern. Class II Integra LifeSciences Corp.
Jul 9, 2024 TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV ... Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when u... Class II Integra LifeSciences Corp.
Jun 7, 2024 AURORA Surgiscope System. Sterile, single use device that contains a Sheath, ... Potential sheath damage that could lead to tissue damage and/or track hemorrhage. Class II Integra LifeSciences Corp.
May 29, 2024 CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical proce... Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of t... Class II Integra LifeSciences Corp.
May 7, 2024 CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to... Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may... Class II Integra LifeSciences Corp.
May 7, 2024 CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for ga... Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may... Class II Integra LifeSciences Corp.
May 7, 2024 CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the vent... Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal tha... Class II Integra LifeSciences Corp.
Apr 17, 2024 Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used duri... Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may com... Class II Integra LifeSciences Corp.
Jan 19, 2024 Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachno... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit ... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 INS7280 / Integra¿ Cranial Access Kit. For access to the subarachnoid space o... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access t... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid ... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Oct 19, 2023 Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoi... Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou... Class II Integra LifeSciences Corp.
Oct 19, 2023 Integra¿ Cranial Access Kit-For access to the subarachnoid space or the later... Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou... Class II Integra LifeSciences Corp.
Oct 19, 2023 Integra Cranial Access Kit- For access to the subarachnoid space or the later... Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou... Class II Integra LifeSciences Corp.
Oct 19, 2023 Integra Cranial Access Kit-For access to the subarachnoid space or the latera... Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou... Class II Integra LifeSciences Corp.
Oct 19, 2023 Integra Cranial Access Kit -For access to the subarachnoid space or the later... Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without... Class II Integra LifeSciences Corp.
Oct 19, 2023 Integra¿ Cranial Access Kit-For access to the subarachnoid space or the later... Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou... Class II Integra LifeSciences Corp.
Oct 19, 2023 Integra Cranial Access Kit-For access to the subarachnoid space or the latera... Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou... Class II Integra LifeSciences Corp.
Oct 19, 2023 Integra Cranial access kit (without Prep solutions) Bit and Guard-For access ... Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without... Class II Integra LifeSciences Corp.
Oct 19, 2023 Integra Cranial Access Kit - For access to the subarachnoid space or the late... Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou... Class II Integra LifeSciences Corp.
Oct 5, 2023 CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with... Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to incl... Class I Integra LifeSciences Corp.
Apr 11, 2023 Codman Cranial Hand Drill- Indicated when a craniotomy is required for placem... Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Dril... Class II Integra LifeSciences Corp.
Dec 2, 2022 Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6... Integra LifeSciences identified that one lot was released with out-of-specification endotoxin res... Class II Integra LifeSciences Corp.
Jun 22, 2022 CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure mon... Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) ... Class I Integra LifeSciences Corp.
Feb 28, 2022 Integra Universal Flexible Arm part number REF 1362275 Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at ... Class II Integra LifeSciences Corp.
Jan 21, 2022 Codman Cranial Access Kits- indicated when a craniotomy is required for place... Incorrect extended expiration dates identified on the outer box label only, if product is used pa... Class II Integra LifeSciences Corp.
Jan 21, 2022 Codman Cranial Access Kits- indicated when a craniotomy is required for place... Incorrect extended expiration dates identified on the outer box label only, if product is used pa... Class II Integra LifeSciences Corp.
Jun 1, 2021 CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hem... Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's... Class II Integra LifeSciences Corp.
Mar 17, 2021 CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Cathe... Incorrect labeling, Catheter did not have the required holes and markings Class II Integra LifeSciences Corp.
Dec 14, 2020 Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use... Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled ... Class II Integra LifeSciences Corp.
Dec 14, 2020 Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: u... Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled ... Class II Integra LifeSciences Corp.
Nov 11, 2020 Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for... Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A20... Class II Integra LifeSciences Corp.
Aug 4, 2020 Integra Padgett Electric Dermatome Set - Product Usage: are intended for use ... lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts... Class II Integra LifeSciences Corp.
Aug 4, 2020 13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 a... lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts... Class II Integra LifeSciences Corp.
Aug 4, 2020 Integra Padgett Dermatome Set - Product Usage: are intended for use in the cu... lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts... Class II Integra LifeSciences Corp.
Feb 7, 2020 NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product U... Nonconforming product which was dispositioned for rejection was mistakenly released for commercia... Class III Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.