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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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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
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
Apr 4, 2017 "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitatio... Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Pro... Class II Helena Laboratories, Inc.
Mar 30, 2017 RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, STERILE R... The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM, REF 71369420, STERILE R... The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1) The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, STERILE R, QT... The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, STERILE R, QT... The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369410, STERILE R, QT... The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, STERILE R, QT... The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, STERILE R, QTY... The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1) The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1) The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY... The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1) The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 24, 2017 WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, ... Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visi... Class II Teleflex Medical
Mar 15, 2017 Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hemat... Avid Medical Inc has received a complaint was received from an end-user indicating the vacutainer... Class II Avid Medical, Inc.
Mar 10, 2017 Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a ... Product shipped proximate to or past the expiration date listed on the product label. Class II Stryker Instruments Div. of Stryker Corporation
Mar 9, 2017 SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, ... Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural ru... Class II C.R. Bard, Inc.
Mar 9, 2017 D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Ort... The expiration dates on the labeling are incorrect, the actual expiration dates are before the da... Class II Smith & Nephew, Inc.
Mar 9, 2017 D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic The expiration dates on the labeling are incorrect, the actual expiration dates are before the da... Class II Smith & Nephew, Inc.
Mar 9, 2017 Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R,... The expiration dates on the labeling are incorrect, the actual expiration dates are before the da... Class II Smith & Nephew, Inc.
Mar 9, 2017 D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: ... The expiration dates on the labeling are incorrect, the actual expiration dates are before the da... Class II Smith & Nephew, Inc.
Mar 8, 2017 BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within ... A single lot of product that potentially has a single part within the lot that does not match the... Class II Biomet 3i, LLC
Mar 3, 2017 It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg).... Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect s... Class II Verathon Inc
Mar 3, 2017 The CG+ Arrow PIC Catheters permit venous access to the central circulation t... Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithro... Class II Arrow International Inc
Mar 3, 2017 ImplantDirect, Dental implants intended for use in partially and fully edentu... The main vial label lists the incorrect part number, but the cap label is correct. Class II Implant Direct Sybron Manufacturing, LLC
Mar 2, 2017 KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK... Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. Class III Microbiologics Inc
Mar 2, 2017 LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO... Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. Class III Microbiologics Inc
Feb 28, 2017 Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages c... For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error... Class II ConMed Corporation
Feb 28, 2017 Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to s... The device did not have Revolve Stereo Probe labeling, no product code indicating the size and le... Class II Devicor Medical Products Inc
Feb 28, 2017 Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages c... For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error... Class II ConMed Corporation
Feb 28, 2017 Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages c... For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error... Class II ConMed 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.