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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

806 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 806 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 806 FDA device recalls.

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DateProductReasonClassFirm
Mar 15, 2018 URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type... Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling o... Class II Biocare Medical, LLC
Mar 12, 2018 Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TM... This device was mislabeled and is not the correct component for this patient. Class II TMJ Solutions Inc
Mar 12, 2018 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 c... Products have been packaged with the wrong Trocar length type. Class II CooperSurgical, Inc.
Jan 2, 2018 Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas... The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/... Class II Roche Diagnostics Corporation
Dec 20, 2017 ACE Trochanteric Nail System TROCH NAIL ST 11X180 125DG STRL TROCH NAIL ST ... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System ATN AR SCREW 60MM STERILE ATN AR SCREW 65MM ST... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System STER TROC NAIL 125 DEG X 9MM STER TROC NAIL 13... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System STER TROC END CAP STER TROC END CAP 5MM STER ... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM ... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System TROCH NAIL ST 13X180 125DG STRL TROCH NAIL ST ... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System STER TROC NAIL 180X13X140 STER TROC NAIL 125 D... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL ... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System STER TROC LAG SCR 70 MM The Trochanteric Nai... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System STER TROC NAIL 180X11X140 STER TROC NAIL 125 D... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 15, 2017 Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01... Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the pr... Class II DePuy Spine, Inc.
Oct 16, 2017 The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for re... Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial... Class II Stryker Instruments Div. of Stryker Corporation
Sep 27, 2017 Reservoir Bag for WalkMed Infusion Pump Part Number 204820 Catalog Number IPR... There have been reported incidents of fluid leaks at the luer connection. Leaks have been confirm... Class II WalkMed, LLC
Aug 1, 2017 Presource(R) Kits (custom surgical/procedural kits): The standard and custom... The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1¿ i... Class II Cardinal Health 200, LLC
Jul 27, 2017 Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are in... A leak may allow for microbial contamination of the sterile fluid path. Class II Baxter Healthcare Corporation
Jul 27, 2017 iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-... FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). Class II Optovue, Inc.
Jun 19, 2017 STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets ... Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates. Class II ConMed Corporation
Jun 19, 2017 STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administr... Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates. Class II ConMed Corporation
Jun 15, 2017 Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES... The firm manufactured and distributed custom surgical kits which contained BD SafetyGlide" 22GA 1... Class II Custom Assemblies Inc
Jun 6, 2017 Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respirat... Real-time shelf life testing failed at 24 months Class II Microbiologics Inc
Apr 17, 2017 AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is ... nail not properly engaging with the targeting jig due to certain undersized specification Class II Zimmer Biomet, Inc.
Apr 6, 2017 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack... Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were ... Class II Amendia, Inc
Mar 31, 2017 Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM There is a risk that the pinion gear in the device could fail under extreme use cases. Class II Ethicon Endo-Surgery Inc
Mar 20, 2017 Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The A... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 7, 2017 AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Mi... Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sh... Class II Aesculap Implant Systems LLC
Feb 23, 2017 Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems i... Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with... Class II Philips Medical Systems (Cleveland) Inc
Feb 23, 2017 Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems in... When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary ga... Class II Philips Medical Systems (Cleveland) Inc
Jan 20, 2017 Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 2002... The firm information that the product was reporting false positive results Class II Gibson Laboratories LLC
Dec 16, 2016 IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spec... Multiple issues have caused the device to result in CT rescans or incorrect scan location or misr... Class II Philips Medical Systems (Cleveland) Inc
Dec 15, 2016 Boston Scientific Imager II Angiographic Catheter, a pathway for delivering c... A field report indicated some units within this lot were missing the bottom pouch seal. The comp... Class II Boston Scientific Corporation
Nov 29, 2016 symmetry surgical ULTRA(R) Sterrad container, REF numbers: C131310-SP, C1313... Sealant on the base trim of sterilizer container may be deteriorated or absent which could provid... Class II Symmetry Surgical, Inc.
Nov 29, 2016 symmetry surgical ULTRA(R) Gravity container, REF numbers: C131310-G, C13134... Sealant on the base trim of sterilizer container may be deteriorated or absent which could provid... Class II Symmetry Surgical, Inc.
Nov 29, 2016 symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C1... Sealant on the base trim of sterilizer container may be deteriorated or absent which could provid... Class II Symmetry Surgical, Inc.
Oct 26, 2016 3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Univer... 3M is recalling Universal Electrosurgical Pads because a report of an unintended material (proces... Class II 3M Company - Health Care Business
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCR... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW ... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCRE... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SC... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCRE... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING ... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCR... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 6, 2016 The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, infla... AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device ... Class II AccessClosure, Inc., A Cardinal Health Company
Sep 29, 2016 Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 1... The insert and case label description of the device incorrectly reads Counter Incrementing Actuat... Class II Thayer Medical Corporation
Sep 13, 2016 ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US,... Customers complained of low/empty reagent vials. Class II TEM Systems Inc
Aug 16, 2016 Pathfast D-Dimer, Reference number: PF1051-KUS Two complaints were received about decrease in sensitivity (control value and/or calibration valu... Class II Lsi Medience Corporation
Aug 12, 2016 Medtronic, Evera Implantable Cardioverter Defibrillators: Product Mo... 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit component... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure

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.