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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
May 4, 2018 remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH ... Product may fail performance testing for S aureus ATCC 43300. Class II Thermo Fisher
May 2, 2018 NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Pa... The bottles are mislabeled with an incorrect part number. Class II Fresenius Medical Care Renal Therapies Group, LLC
May 1, 2018 Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental im... The implants are mislabeled. Class II Keystone Dental Inc
Apr 25, 2018 Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 Usage: Exacta-Mix 2400... Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The i... Class II Baxter Healthcare Corporation
Apr 25, 2018 Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Ex... Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The i... Class II Baxter Healthcare Corporation
Apr 25, 2018 Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product... Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The i... Class II Baxter Healthcare Corporation
Apr 25, 2018 Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Pro... It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier ... Class II ConvaTec, Inc
Apr 25, 2018 Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exa... Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The i... Class II Baxter Healthcare Corporation
Apr 23, 2018 DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4... Non-sterile product was packaged inside a case that was labeled as sterile. Class II DeRoyal Industries Inc
Apr 20, 2018 LINX Reflux Management System, Implant Clasp, 13-17 Bead, 1.5T, Product Code ... Possible out of specification condition which may allow a bead component to separate from an adja... Class II Torax Medical, Inc.
Apr 20, 2018 LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code ... Possible out of specification condition which may allow a bead component to separate from an adja... Class II Torax Medical, Inc.
Apr 20, 2018 Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris P... Complaints where users were unable to prime the administration set. Class II CareFusion 303, Inc.
Apr 20, 2018 LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code... Possible out of specification condition which may allow a bead component to separate from an adja... Class II Torax Medical, Inc.
Apr 20, 2018 LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code ... Possible out of specification condition which may allow a bead component to separate from an adja... Class II Torax Medical, Inc.
Apr 20, 2018 LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code ... Possible out of specification condition which may allow a bead component to separate from an adja... Class II Torax Medical, Inc.
Apr 16, 2018 Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: P... Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm b... Class II Cook Inc.
Apr 16, 2018 AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 ... Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using compone... Class II Spinal Elements
Apr 13, 2018 Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model ... The products are labeled with an incorrect product number. Class II Coltene Whaledent Inc
Apr 13, 2018 Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Ca... Devices inappropriately displayed a low battery indicator determined to be due to memory corruption. Class II St Jude Medical, Cardiac Rhythm Management Divi...
Apr 9, 2018 smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 7... A single lot of GENESIS II FEMORAL FIVE DEGREE VALGUS BUSHING due to a laser mark labeling error.... Class II Smith & Nephew, Inc.
Apr 9, 2018 VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux S... Invalid calibration with low calibrator S1 while using the product. Class II BioMerieux SA
Apr 6, 2018 Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Pa... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part N... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbe... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Num... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number)... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on labe... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Pa... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Non-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on ... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part N... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Pa... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbe... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 EasyTouch (ET) Insulin Syringe 29G 0.5ml ¿" (Item 829555) Product Usage: ... The retail shelf cartons may be labeled with an incorrect lot number. Class II MHC Medical Products LLC
Apr 6, 2018 EasyTouch (ET) Insulin Syringe 29G 1ml ¿" (Item 829155) Product Usage: IN... The retail shelf cartons may be labeled with an incorrect lot number. Class II MHC Medical Products LLC
Apr 6, 2018 T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number)... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Le... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx On... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Par... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number)... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx ... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 4, 2018 Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage:... Tip of the curing light was too hot causing a heat sensation in the patients. Class II Handpiece Headquarters
Apr 2, 2018 Bivona¿ Tracheostomy Tube Tracheostomy Tubes Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as s... Class II Smiths Medical ASD Inc.
Mar 23, 2018 The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to ... A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... Class II BioMerieux SA
Mar 23, 2018 Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Num... Medtronic has become aware that certain lots of the VCLAS 3MM, 10MM, and 15MM laser diffusing fib... Class II Medtronic Navigation, Inc.
Mar 21, 2018 Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Pro... Medline notified BMD that the Aplicare Povidone Iodine (PVP-I) Prep Pads were not meeting the iod... Class II Bard Medical Division
Mar 20, 2018 BD Vacutainer¿ Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿... Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. Class II Becton Dickinson & Company
Mar 20, 2018 BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ ... Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. Class II Becton Dickinson & Company

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.