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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

3,282 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,282 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 3,282 FDA device recalls.

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DateProductReasonClassFirm
Jul 31, 2013 "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors ... The Edwards Lifesciences FloTrac Sensor is being recalled due to a manufacturing non-conformance ... Class II Edwards Lifesciences, LLC
Jul 30, 2013 Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fi... Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect label... Class II Synthes USA HQ, Inc.
Jul 30, 2013 Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment... The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole... Class II Synthes USA HQ, Inc.
Jul 30, 2013 Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject P... Complaints were received of inconsistencies in the expiration dates shown on the packaging of the... Class II Synthes USA HQ, Inc.
Jul 25, 2013 STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization Sys... The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (... Class II Advanced Sterilization Products
Jul 24, 2013 GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, St... On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated... Class II Gyrus Medical, Inc
Jul 24, 2013 3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System ... OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #913... Class II OrthoPediatrics Corp
Jul 19, 2013 C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tiss... Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner pac... Class II Atrium Medical Corporation
Jul 19, 2013 C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficienc... Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner pac... Class II Atrium Medical Corporation
Jul 19, 2013 C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue... Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner pac... Class II Atrium Medical Corporation
Jul 19, 2013 C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue de... Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner pac... Class II Atrium Medical Corporation
Jul 16, 2013 Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Ste... Zimmer recently conducted a review of historic packaging validations completed. Based on this re... Class II Zimmer, Inc.
Jul 8, 2013 Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis. the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil ... Class II Baxter Healthcare Corp.
Jun 25, 2013 ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage:... ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occu... Class III Convatec Inc.
Jun 25, 2013 ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage f... ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occu... Class III Convatec Inc.
Jun 24, 2013 SC2316, Distal Femoral Augment with Screw Total knee replacement due to os... The firm became aware of an incident relating to a breach of sterility in the sterility barrier p... Class II Stelkast Co
Jun 19, 2013 VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 m... Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... Class II Zimmer, Inc.
Jun 19, 2013 VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and shor... Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... Class II Zimmer, Inc.
Jun 19, 2013 Free Lock Femoral Hip Fixation System Compression Tube/Plate, different lengt... Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... Class II Zimmer, Inc.
Jun 19, 2013 Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths... Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... Class II Zimmer, Inc.
Jun 19, 2013 VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and shor... Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... Class II Zimmer, Inc.
Jun 4, 2013 Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disp... Utah Medical Products, Inc. is recalling certain Deltran Disposable Pressure Transducer Kits due ... Class II Utah Medical Products, Inc
Jun 3, 2013 Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert O... Alere initiated this recall of certain lots of the Oral Fluid Drug Screen Device because the spon... Class II Alere San Diego, Inc.
May 31, 2013 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUS... Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the... Class II Karl Storz Endoscopy America Inc
May 23, 2013 Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, ... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; si... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO; singl... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular Sterile, EO; sing... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; singl... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO;... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; ... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; sin... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O; single ... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, E... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO; single... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single u... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; si... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single us... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; singl... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single us... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 15, 2013 Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Conta... A firm's internal investigation led to the discovery of pinholes in the packaging of the products... Class II Baxter Healthcare Corp.
May 15, 2013 Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Prod... A firm's internal investigation led to the discovery of pinholes in the packaging of the products... Class II Baxter Healthcare Corp.
May 15, 2013 Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Contai... A firm's internal investigation led to the discovery of pinholes in the packaging of the products... Class II Baxter Healthcare Corp.
May 8, 2013 DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 ... LifeLiner Stick and Cut Resistant Gloves are being recalled because cases and individual glove pa... Class III DePuy Orthopaedics, Inc.
Apr 30, 2013 FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray. American Optisurgical, Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator, in re... Class II American Optisurgical Inc
Apr 12, 2013 Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Colopla... Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorre... Class II Coloplast Manufacturing US, LLC
Apr 12, 2013 BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptiv... In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiologic... Class II Becton Dickinson & Co.
Apr 12, 2013 BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive di... In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiologic... Class II Becton Dickinson & Co.
Apr 8, 2013 Endopath Electrosurgery Probe Plus II, twelve (12) different devices, includi... The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in th... Class II Ethicon Endo-Surgery Inc
Mar 28, 2013 Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile uri... Sterile packaging may be compromised. Class II Teleflex Medical

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.