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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
Dec 16, 2016 Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellc... Labeling error: The label indicates the product is latex free, but the headband component include... Class II Covidien LLC
Dec 16, 2016 Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrai... labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the ... Class II Zimmer Biomet, Inc.
Dec 13, 2016 Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer p... One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The ... Class II Boston Scientific Corporation
Dec 9, 2016 Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Steri... The label of the CADD Blue-Striped Administrative Set is missing the expiration date, which is co... Class II Smiths Medical ASD Inc.
Dec 7, 2016 DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Or... CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED. Class II Cardiovascular Systems Inc
Dec 6, 2016 Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Ste... Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mis... Class II Zimmer Biomet, Inc.
Dec 5, 2016 EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-... Unique Device Identifier (UDI) is missing from outer kit box label. Class III PerkinElmer Health Sciences, Inc.
Nov 30, 2016 Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only. The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the... Class III Ecolab Inc
Nov 28, 2016 GoDirect Screw-Retaining Top Part Numbers: 4500-61 Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDi... Class II Implant Direct Sybron Manufacturing, LLC
Nov 23, 2016 i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmac... The firm has initiated a product correction due to a bag carousel motor error causing misalignmen... Class II HEALTH ROBOTICS S.R.L.
Nov 22, 2016 Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine l... Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the... Class II Reckitt Benckiser LLC
Nov 22, 2016 RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 ... Labeling Inconsistency: The products have been labeled with the incorrect expiration date which ... Class II Teleflex Medical
Nov 22, 2016 Zeus-P Lumbar Interbody Device Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluat... Class II Amendia, Inc
Nov 18, 2016 OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical... Labeled as a 48mm Cortical Screw but measuring at 50mm Class III OrthoPediatrics Corp
Nov 17, 2016 UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT ... There was a labeling error with product, UltraSeal XT Plus Clear Refill, Part Number (PN) 565, Lo... Class II Ultradent Products, Inc.
Nov 15, 2016 BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only... Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated th... Class II Robert Busse & Co. Inc. d.b.a. Busse Hospital D...
Nov 15, 2016 ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, St... The vial cap was mislabeled with the incorrect part number of 855708 but the product description ... Class II Implant Direct Sybron Manufacturing, LLC
Nov 15, 2016 SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Onl... Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated th... Class II Robert Busse & Co. Inc. d.b.a. Busse Hospital D...
Nov 15, 2016 CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE,... Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated th... Class II Robert Busse & Co. Inc. d.b.a. Busse Hospital D...
Nov 15, 2016 Empowr Knee System Product Usage: Non-porous proximal tibial baseplate im... A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, ma... Class II Encore Medical, Lp
Nov 7, 2016 Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte,... Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies ... Class II Exactech, Inc.
Nov 7, 2016 Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6 Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies ... Class II Exactech, Inc.
Nov 7, 2016 AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +... Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies ... Class II Exactech, Inc.
Nov 7, 2016 BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use ... BD is conducting a voluntary product recall of the BD Spinal Anesthesia Tray, Cat (Ref) 405671, l... Class II Becton Dickinson & Company
Nov 3, 2016 VOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M... Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Univ... Class II Voco GmbH
Nov 3, 2016 Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347. Terumo BCT announces a voluntary field action for the Harvest : Adiprep Adipose Transfer System b... Class II Terumo BCT, Inc.
Nov 1, 2016 Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm ... Class II Synthes (USA) Products LLC
Oct 31, 2016 Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2... Owens & Minor is the initial importer and private label distributor of Medi Choice Arm Slings (Pr... Class II Owens & Minor Distribution, Inc.
Oct 31, 2016 HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotl... HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the requir... Class III Smiths Medical ASD, Inc.
Oct 26, 2016 Atrium Medical 24 Fr Trocar catheter, Sterile Model Number: 8424 Intende... Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) tha... Class II Atrium Medical Corporation
Oct 26, 2016 Atrium Medical 12 Fr Trocar catheter, Sterile Model Number: 8412 Intended... Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) tha... Class II Atrium Medical Corporation
Oct 26, 2016 Atrium Medical 28 Fr Trocar catheter, Sterile Model Number: 8428 Inten... Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) tha... Class II Atrium Medical Corporation
Oct 26, 2016 Atrium Medical 10 Fr Trocar catheter, Sterile Model Number: 8410 Intended... Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) tha... Class II Atrium Medical Corporation
Oct 26, 2016 Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended... Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) tha... Class II Atrium Medical Corporation
Oct 26, 2016 Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intende... Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) tha... Class II Atrium Medical Corporation
Oct 26, 2016 Atrium Medical 32 Fr Trocar catheter, Sterile Model Number: 8432 Intend... Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) tha... Class II Atrium Medical Corporation
Oct 26, 2016 Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facil... Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) tha... Class II Atrium Medical Corporation
Oct 25, 2016 ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non... DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due... Class II Depuy Orthopaedics Inc.
Oct 25, 2016 NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reo... Smiths Medical became aware that that one (1) NORMOFLO¿ H-1100 Irrigation Fluid Warmers was incor... Class II Smiths Medical ASD, Inc.
Oct 21, 2016 is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for t... Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. Class III Euro Diagnostica AB
Oct 21, 2016 is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assa... Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. Class III Euro Diagnostica AB
Oct 21, 2016 is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for t... Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. Class III Euro Diagnostica AB
Oct 21, 2016 is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for t... Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. Class III Euro Diagnostica AB
Oct 20, 2016 Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a... A product issues happens for RF projection images. If user measures on RF image, .cal (Calibratio... Class II Merge Healthcare, Inc.
Oct 18, 2016 ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Ca... Mislabeled: incorrect serial number on the F4 A/P cut guide iJig. Class II ConforMIS, Inc.
Oct 18, 2016 Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed ... Labeling inconsistency - units labeled with a 7mm tube may contain a size 6.5mm tube, and units l... Class II Teleflex Medical
Oct 13, 2016 Bard Inlay Optima¿ Multi-Length Ureteral Stent Coated Double Pigtail Ureteral... Labeling: Statement was added to the Warnings/Precautions section requesting end users to conside... Class II C.R. Bard, Inc.
Oct 13, 2016 Ingenuity CT Computed Tomography X-ray system, Model 728326 The product label does not include the correct current rating. Class III Philips Medical Systems (Cleveland) Inc
Oct 13, 2016 Ingenuity Core 128 Computed Tomography X-ray system, Model 728323 The product label does not include the correct current rating. Class III Philips Medical Systems (Cleveland) Inc
Oct 13, 2016 Bard Fluoro-4 Silicone Ureteral Stent, Bard¿ Fluoro-4", Silicone Ureteral Coi... Labeling: Statement was added to the Warnings/Precautions section requesting end users to conside... Class II C.R. Bard, 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.