Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

3,133 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,133 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 3,133 FDA device recalls.

Clear
DateProductReasonClassFirm
Mar 1, 2024 Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for an... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Mar 1, 2024 Dilator - Intended to be used for dilating puncture sites or catheter tracts ... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Mar 1, 2024 Peel-Away Introducer - Intended for the percutaneous introduction of balloon,... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Feb 21, 2024 SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pa... Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be br... Class II Alcon Research, LLC
Feb 6, 2024 NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM Potential packaging breaches of inner blister and outer sterile blister. Class II Howmedica Osteonics Corp.
Feb 6, 2024 NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM Potential packaging breaches of inner blister and outer sterile blister. Class II Howmedica Osteonics Corp.
Feb 6, 2024 X3 TRIATHLON CS INSERT NO 6 11 MM Potential packaging breaches of inner blister and outer sterile blister. Class II Howmedica Osteonics Corp.
Feb 6, 2024 X3 TRIATHLON CS INSERT NO 7 9 MM Potential packaging breaches of inner blister and outer sterile blister. Class II Howmedica Osteonics Corp.
Feb 6, 2024 NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM Potential packaging breaches of inner blister and outer sterile blister. Class II Howmedica Osteonics Corp.
Feb 6, 2024 X3 TRIATHLON CS INSERT NO 3 10 MM Potential packaging breaches of inner blister and outer sterile blister. Class II Howmedica Osteonics Corp.
Feb 6, 2024 X3 TRIATHLON CS INSERT NO 6 10 MM Potential packaging breaches of inner blister and outer sterile blister. Class II Howmedica Osteonics Corp.
Feb 6, 2024 NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM Potential packaging breaches of inner blister and outer sterile blister. Class II Howmedica Osteonics Corp.
Jan 22, 2024 LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- In... Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it shoul... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
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.
Jan 9, 2024 DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic pr... The sterile blister packaging may be damaged, and sterility may be compromised. Class II Aesculap Inc
Jan 9, 2024 DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparo... The sterile blister packaging may be damaged, and sterility may be compromised. Class II Aesculap Inc
Jan 9, 2024 DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparos... The sterile blister packaging may be damaged, and sterility may be compromised. Class II Aesculap Inc
Jan 9, 2024 DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparos... The sterile blister packaging may be damaged, and sterility may be compromised. Class II Aesculap Inc
Jan 9, 2024 DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic pr... The sterile blister packaging may be damaged, and sterility may be compromised. Class II Aesculap Inc
Jan 4, 2024 Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testin... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 22, 2023 Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO Sterility assurance for saline included in surgical kits cannot be guaranteed. Class I Windstone Medical Packaging, Inc.
Dec 22, 2023 Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO Sterility assurance for saline included in surgical kits cannot be guaranteed. Class I Windstone Medical Packaging, Inc.
Dec 22, 2023 Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO Sterility assurance for saline included in surgical kits cannot be guaranteed. Class I Windstone Medical Packaging, Inc.
Dec 22, 2023 Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO Sterility assurance for saline included in surgical kits cannot be guaranteed. Class I Windstone Medical Packaging, Inc.
Dec 11, 2023 Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, pre... Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have... Class II Globus Medical, Inc.
Dec 11, 2023 Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, prep... Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have... Class II Globus Medical, Inc.
Dec 11, 2023 Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, a... Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have... Class II Globus Medical, Inc.
Dec 11, 2023 Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilat... The expiration date is missing from the primary (inner) packaging. The secondary (outer) box labe... Class II Olympus Corporation of the Americas
Nov 20, 2023 Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-... Seal defects could compromise the ability of the product packaging to maintain sterility. Class II Medtronic Inc.
Nov 16, 2023 AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -int... Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentia... Class II Covidien LP
Nov 10, 2023 DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 L... Due to incorrect product/device within packaging. Class II Encore Medical, LP
Nov 2, 2023 Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01 One product complaint was received reporting that there was an incorrect adapter in the packaging... Class II Biomet, Inc.
Nov 2, 2023 Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02 One product complaint was received reporting that there was an incorrect adapter in the packaging... Class II Biomet, Inc.
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.

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.