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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

3,164 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,164 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 3,164 FDA device recalls.

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DateProductReasonClassFirm
May 7, 2020 Stryker End Cap T2 Humerus ¿6mm, 15mm height Catalog Number: 18300015S - P... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker 1 End Cap T2 Humerus ¿6mm, 5mm height Catalog Number: 18300005S - ... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker Locking Screw, Partially Threaded T2 Tibia ¿5x55 mm Catalog Number: ... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 1896... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: ... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage:... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Catalog Number: 18... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Pr... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max ... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Quick... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max B... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quic... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3F... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Quick... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Exte... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quic... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Sit... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pedia... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max B... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Mar 27, 2020 Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Ju... A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration... Class II Stryker Sustainability Solutions
Mar 17, 2020 Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 A... Sterility compromised due to packaging pouches that may not be sealed properly Class II Bard Peripheral Vascular Inc
Mar 13, 2020 Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model ... There were unknown bioburden levels prior to sterilization, which may affect sterility of the pro... Class II Biomet, Inc.
Mar 9, 2020 Custom convenience kits containing Medline brand Sterile Pre-Saturated Povido... Medline identified that there may be a potential for voids in the packaging seal and loss of ster... Class II Medline Industries Inc
Feb 10, 2020 Medline Winged Sponges Presaturated W/PVP REF DYND70289 DYND70289H Expiration... Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ... Class II Medline Industries Inc
Feb 10, 2020 Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G... Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ... Class II Medline Industries Inc
Feb 10, 2020 Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expirat... Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ... Class II Medline Industries Inc
Jan 21, 2020 Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 e... The sterile pack inside the Complete Delivery System (CDS) did not go through a complete steriliz... Class II Medline Industries Inc
Jan 21, 2020 Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTI... The sterile pack inside the Complete Delivery System (CDS) did not go through a complete steriliz... Class II Medline Industries Inc
Jan 13, 2020 Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm,... There is a potential for the device packaging to become compromised; thus, the sterility of the d... Class II TELEFLEX MEDICAL INC
Jan 13, 2020 Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440 There is a potential for the device packaging to become compromised; thus, the sterility of the d... Class II TELEFLEX MEDICAL INC
Dec 30, 2019 TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intende... Due to a potential for sterile barrier breach. A complaint was received that indicated the protec... Class II Smith & Nephew, Inc.
Dec 19, 2019 STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-... Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope steriliz... Class II Intuitive Surgical, Inc.
Dec 19, 2019 STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02... Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope steriliz... Class II Intuitive Surgical, Inc.
Dec 18, 2019 Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Produ... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Produ... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Produ... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Pr... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Pr... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Pro... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL22... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - P... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Pro... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture 0 30" VIOLET GU-46, Item Code UL877 - Prod... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - Produ... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL4... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Pro... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC

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.