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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
Jun 15, 2017 Vis-U-All High Temp 10"x15" Heat Seal Pouch 100 pouches per box; 5 boxes per ... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per ca... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 6, 2017 Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchang... Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite At... Class II Spectranetics Corporation
Jun 5, 2017 ECHO POR FMRL NC 9X125, model # 192009 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 Lateral Troch Plate Full Crimp - 254mm, model # 350837 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 CER BIOLOXD OPTION HD 32MM, model # 650-1056 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 COMP PRIMARY STEM 8MM MINI, model # 113628 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 OSS CEMENTED IM STEM 12X150, model # 150366 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 COMP 12MM HUM FRAC STEM MACRO, model # 11-113562 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 Lateral Troch Plate Full Crimp - 254mm, model # 350838 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 2, 2017 Arctic Sun ArcticGel Pads - Medium, Product Code 317-07 Label on product box contains the incorrect reference #317-09 while the shelf box label with barc... Class III C.R. Bard, Inc.
Jun 1, 2017 Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above... Label on the affected devices incorrectly identifies the injection location as "above" the ball... Class II Boston Scientific Corporation
Jun 1, 2017 Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below... Label on the affected devices incorrectly identifies the injection location as "above" the ball... Class II Boston Scientific Corporation
May 31, 2017 PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collec... PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pac... Class III PerkinElmer Health Sciences, Inc.
May 25, 2017 Logic Fit Tibial Tamp Head The firm determined that the labeling (surgical technique) should be updated to clarify the prope... Class II Exactech, Inc.
May 25, 2017 BD Insulin Syringes with the BD Ultra-Fine(TM) needle ¿ mL 12.7mm 30G, Catalo... Product mislabel. Lot 6291768 of the BD Insulin Syringes with the BD Ultra-Fine needle ¿mL 12.7m... Class II Becton Dickinson & Company
May 25, 2017 6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyuretha... The kit was packaged with the incorrect introducer needle size. The label indicates the kit cont... Class II Medical Components, Inc dba MedComp
May 24, 2017 Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used wi... The inner and outer labels on the product contain incorrect reference number of 9-202-3751DS. Acc... Class II Northgate Technologies, Inc.
May 24, 2017 Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Ha... Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol t... Class II Merge Healthcare, Inc.
May 23, 2017 ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGT... The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm Class II Onkos Surgical, Inc.
May 23, 2017 ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGT... The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm Class II Onkos Surgical, Inc.
May 23, 2017 ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGT... The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm Class II Onkos Surgical, Inc.
May 22, 2017 Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in th... The firm determined that the labeling (surgical technique) should be updated to clarify the prope... Class II Exactech, Inc.
May 22, 2017 PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Nu... Flowonix Medical received a report of a patient implanted with the Prometra II Programmable Pump ... Class II Flowonix Medical, Inc.
May 22, 2017 DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-... FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit b... Class III Euro Diagnostica AB
May 19, 2017 BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot... Class II CryoLife, Inc.
May 16, 2017 Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactec... Possible inner labeling and packaged device not matching the outer label on the box. Class II Exactech, Inc.
May 16, 2017 Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exacte... Possible inner labeling and packaged device not matching the outer label on the box. Class II Exactech, Inc.
May 12, 2017 Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended f... Kit was labeled with the incorrect Expiration Date of April 30, 2019. Class II Terumo Cardiovascular Systems Corp
May 11, 2017 Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system co... Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent... Class II GE Medical Systems, LLC
May 11, 2017 Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets m... Product size listed on the labeling is incorrect. Class II Teleflex Medical
May 9, 2017 Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only, Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult ... Class II Teleflex Medical
May 8, 2017 Merge PACS software. The firm name on the label is Merge Healthcare, Hartlan... Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk... Class II Merge Healthcare, Inc.
May 8, 2017 Beekley Medical 0-SPOT Mammography Skin Markers REF 652 Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels Class III Beekley Corporation
May 5, 2017 Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagn... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 Estrogen Receptor (EP1) 7.0 mL Catalog number 249R-28; 1.0 mL Catalog num... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 SV40 (MRQ-4) 0.5 ml catalog number 351 M-15. Microbiology - Analyte Spec... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 Estrogen Receptor (SP1) 7.0 mL Catalog number 249R-18; Hematology - Anal... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 CD117, c-kit (YR145) 1.0 ml catalog number 117R-16 7.0 ml catalog number-18... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 Adenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog nu... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 Herpes Simplex Virus II 0.5 ml catalog number 362A-15 7.0 mL Catalog number... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-2... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Ana... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 Varicella Zoster Virus 7.0 ml catalog number 364M-18 Microbiology - Analy... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyt... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 HHV-8 (13810); 1.0 ml catalog number 265M-16; 7.0 ml catalog number-265M-18... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
Apr 28, 2017 NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthr... Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen... Class II Zimmer Biomet, 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.