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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

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

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DateProductReasonClassFirm
Jan 24, 2014 Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packa... The product may contain high levels of microbial contamination Class II Remel Inc
Jan 24, 2014 NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packa... Mislabeled product. Class II NxStage Medical, Inc.
Jan 24, 2014 Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart... HeartStart XL+ battery charge time to 100% capacity at 35¿C (95¿F) is slightly longer than the sp... Class II Philips Medical Systems, Inc.
Jan 21, 2014 Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 2000091... Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed. Class II Dako North America Inc.
Jan 16, 2014 LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System... Zest Anchors, LLC is voluntarily recalling specific lots of LOCATOR¿ Implant Attachment Systems b... Class II Zest Anchors LLC
Jan 10, 2014 Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture s... Product does not function as intended up to the expiry date on the product labeling. There is a ... Class II Leica Microsystems, Inc.
Jan 9, 2014 Restoris Multicompartmental Knee (MCK) System is an implant system designed t... The product may be mislabeled and could result in the incorrect implant being used. Class II Mako Surgical Corporation
Jan 8, 2014 ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with L... Anspach product code L-3SD contained product code S-3SD which is shorter in length than the label... Class II The Anspach Effort, Inc.
Jan 6, 2014 Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A,... Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2... Class II Medtronic Sofamor Danek USA Inc
Jan 6, 2014 Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Numb... Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant,... Class II Zimmer Dental Inc
Jan 6, 2014 cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cob... Numerous complaints have been filed that leaking cobas ¿ PCR media 4.3 mL IVD have been received ... Class II Roche Molecular Systems, Inc.
Jan 3, 2014 Composix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P ... Product labeling does not match product configuration. Class II Davol, Inc., Subs. C. R. Bard, Inc.
Jan 3, 2014 Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Me... Product labeling does not match product configuration. Class II Davol, Inc., Subs. C. R. Bard, Inc.
Dec 19, 2013 Locking Cortical Screw 3.5mmX38mm REF 8161-35-038 3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified ... Class II Biomet, Inc.
Dec 18, 2013 Radial Assist RAD BOARD, used to support the weight of a patient's arm and s... Merit Medical Systems, Inc. is voluntarily recalling one lot (B507171) of RAD BOARD RB 100 device... Class II Merit Medical Systems, Inc.
Dec 18, 2013 ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-le... HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers running the Creatinine ass... Class III Horiba Instruments, Inc dba Horiba Medical
Dec 13, 2013 SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10... Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark.... Class II Highland Metals, Inc.
Dec 13, 2013 SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10... Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark.... Class II Highland Metals, Inc.
Dec 12, 2013 Panda iRes¿ Infant Warmers, part number M1112198 and Panda Freestanding Warme... Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mix... Class II GE Healthcare
Dec 12, 2013 Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139... Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mix... Class II GE Healthcare
Dec 12, 2013 King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is inten... On December 13, 2012, King Systems initiated a voluntary recall of one (1) case(s) (5) individual... Class II King Systems Corp.
Dec 12, 2013 Giraffe¿ Infant Warmers, part number M1118179, labeled in part *** GE Healthc... Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mix... Class II GE Healthcare
Dec 12, 2013 Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled i... Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mix... Class II GE Healthcare
Dec 12, 2013 Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 20... Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mix... Class II GE Healthcare
Dec 12, 2013 Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M122... Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mix... Class II GE Healthcare
Dec 11, 2013 Latex Dental Dams labeled as Non-Latex Dental Dams Colt¿ne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. Dur... Class II Coltene Whaledent Inc
Dec 10, 2013 External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx... The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fac... Class II BioHorizons Implant Systems Inc
Dec 10, 2013 Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The r... Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabec... Class II Zimmer, Inc.
Dec 10, 2013 CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/poly... Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabec... Class II Zimmer, Inc.
Dec 10, 2013 Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip... Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabec... Class II Zimmer, Inc.
Dec 6, 2013 MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Pr... Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Cathet... Class II Bard Access Systems
Dec 6, 2013 Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone... Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Cathet... Class II Bard Access Systems
Dec 6, 2013 Catheter, Continuous Flush The Merit Microcatheter is intended for general i... Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a gr... Class II Merit Medical Systems, Inc.
Dec 4, 2013 Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brillianc... Machine Name in TumorLOC Basic Mode is obscured. When TumorLOC is in Basic Mode and Set Vertical ... Class II Philips Medical Systems (Cleveland) Inc
Dec 3, 2013 ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Editio... Baxter Healthcare Corporation is issuing a voluntary correction for ABACUS Total parenteral Nutri... Class II Baxter Corporation Englewood
Nov 26, 2013 outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Sin... Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906... Class II Biomet, Inc.
Nov 26, 2013 G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000 Investigation identified that the outer label, inner label, and patient label all have the incorr... Class II Biomet, Inc.
Nov 26, 2013 Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial... Integra LifeSciences is voluntarily recalling any unexpired lots of HITHSP10 Cranial Access Kits... Class II Integra LifeSciences Corp. d.b.a. Integra Pain ...
Nov 25, 2013 Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plasti... Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of ste... Class II Navilyst Medical, Inc.
Nov 21, 2013 Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg ... Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in sma... Class II Remel Inc
Nov 20, 2013 ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses ... Lots were labeled with incorrect expiration dates on secondary package (carton). The primary pac... Class II CooperVision Inc.
Nov 20, 2013 Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses,... Lots were labeled with incorrect expiration dates on secondary package (carton). The primary pac... Class II CooperVision Inc.
Nov 20, 2013 Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straig... Edwards Lifesciences is recalling one lot of Ergonic instrument due to mislabeling. Ergonic scis... Class III Edwards Lifesciences, LLC
Nov 18, 2013 CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-... Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the St... Class II Medtronic Neurosurgery
Nov 18, 2013 Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata ... Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the St... Class II Medtronic Neurosurgery
Nov 18, 2013 Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0... Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the St... Class II Medtronic Neurosurgery
Nov 14, 2013 Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Th... Modification of the bacterial overflow guard (filter) and related changes to product labeling. Class II Smith & Nephew Inc.
Nov 14, 2013 Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wou... Modification of the bacterial overflow guard (filter) and related changes to product labeling. Class II Smith & Nephew Inc.
Nov 6, 2013 IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 ... potential for an accelerated decline in counts per second (CPS) for three IMMULITE/IMMULITE 1000... Class II Siemens Healthcare Diagnostics
Nov 6, 2013 Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeo... KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper w... Class II Karl Storz Endoscopy America Inc

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.