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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

5,424 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,424 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 5,424 FDA device recalls.

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DateProductReasonClassFirm
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.
Apr 27, 2017 AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. PEG kits have the potential for one of the following defects: missing components, duplicate compo... Class II AbbVie Inc.
Apr 27, 2017 AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. PEG kits have the potential for one of the following defects: missing components, duplicate compo... Class II AbbVie Inc.
Apr 27, 2017 Liquid Urine Control Level 3 For Professional Use in the quality control m... According to Randox Laboratories an investigation indicates a labelling error for 2 of the test m... Class III Randox Laboratories
Apr 26, 2017 Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The ... Zimmer Biomet is conducting a voluntary recall for a single lot of the Modular Hybrid Glenoid Bas... Class II Zimmer Biomet, Inc.
Apr 24, 2017 Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reage... Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of ... Class II Beckman Coulter Inc.
Apr 21, 2017 PE CONNECTOR 5 IN 1 20/BX, Sterile, Single use, Product Usage: Catheter C... Labeling: The expiration date is not stated on the labeling, there is a potential for expired pro... Class II Teleflex Medical
Apr 21, 2017 PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Cat... Labeling: The expiration date is not stated on the labeling, there is a potential for expired pro... Class II Teleflex Medical
Apr 21, 2017 PE CONNECTOR 3/8 Y 20/BX, Sterile, Single use, Product Usage: Catheter C... Labeling: The expiration date is not stated on the labeling, there is a potential for expired pro... Class II Teleflex Medical
Apr 20, 2017 Microfil Composite Instruments are packaged in an unsealed plastic sleeve, wh... Microfil Composite Instruments were distributed with a sterile symbol on their packaging label in... Class II Almore International Inc
Apr 19, 2017 Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps ar... There is a material mislabeling of the AFN End Cap. Class II Ortho Solutions Inc
Apr 12, 2017 LASER CDS Multiple surgical packs were assembled with a non-sterile CHG applicators labeled as "ChloraPrep"... Class II Medline Industries, Inc.
Apr 12, 2017 Laparoscopy CDS One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled st... Class II Medline Industries, Inc.
Apr 12, 2017 Bone Dowell Harvest Tubes mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously subst... Class II Zimmer Biomet, Inc.
Apr 12, 2017 5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The produc... The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cob... Class II XTANT MEDICAL INC
Apr 12, 2017 PICC Tray, STERILE, 12 packs each per case. Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit com... Class II Medline Industries, Inc.
Apr 12, 2017 Art-Line Surgery Pack-LF, STERILE, 40 packs each per case. Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit com... Class II Medline Industries, Inc.
Apr 10, 2017 CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit an... The current secondary packaging, a box, incorrectly states that the product is latex free. The pr... Class II CooperSurgical, 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
Apr 5, 2017 The JETSTREAM is a rotational atherectomy catheter system designed for use in... Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lo... Class II Boston Scientific 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.