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Vehicle Safety

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

2,260 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,260 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 2,260 FDA device recalls in 2021.

Clear
DateProductReasonClassFirm
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM I... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3... Excess nylon flash on the clip. Class II Medtronic Neuromodulation
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Ite... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM I... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
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.
Jun 1, 2021 Medtronic Reveal LINQ LNQ11 / PA96000 Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 1, 2021 OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross imm... Due to insufficient column strength of the racks for all load conditions, racks associated with h... Class II Ossur Americas
May 28, 2021 Affinity Four Birthing Bed-used as a birthing bed for women of child bearing ... Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it cou... Class II Hill-Rom, Inc.
May 28, 2021 Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128 This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Stimulen Collagen Moisturizing Lotion, ST9555B Dose audit failure after sterilization process Class II Southwest Technologies Inc
May 28, 2021 Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119 This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123 This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133 This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144 This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray compone... Two lots have been swapped thus have the incorrect product in the package. The component may be o... Class II Tornier, Inc
May 28, 2021 Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated fo... The pump has an impeller with a shroud height that did not meet the lower control limit. Class II Heartware, Inc.
May 28, 2021 Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155 This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 27, 2021 Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), C... The devices have a different inner diameter than the diameter specified on the outer box label. Class II Stryker GmbH
May 27, 2021 Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, R... Product distributed for use as an In-vitro Diagnostics without FDA clearance Class II Cell Marque Corporation
May 27, 2021 Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless stee... Tip of the screwdriver does not have the correct configuration / profile therefore the screwdrive... Class II Straumann USA LLC
May 27, 2021 Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte sp... May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe fai... Class II Cytocell Ltd.
May 27, 2021 Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), C... The devices have a different inner diameter than the diameter specified on the outer box label. Class II Stryker GmbH
May 27, 2021 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Tele... Telepack may not power on when using the 3AA battery cradle. Class III Mindray DS USA, Inc. dba Mindray North America
May 27, 2021 ARTIS pheno- angiography systems developed for single and biplane diagnostic ... Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a ... Class II Siemens Medical Solutions USA, Inc
May 27, 2021 Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, I... Product distributed for use as an In-vitro Diagnostics without FDA clearance Class II Cell Marque Corporation

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.