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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

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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

3,164 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,164 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 3,164 FDA device recalls.

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DateProductReasonClassFirm
Nov 8, 2016 OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnCon... Sterility: Due to a potential incomplete seal on the outer sterile package. Class II Teleflex Medical
Nov 8, 2016 INBONE STEM, TIBIAL, TOP, Part Number 200011901 The firm discovered a lack of adequate documentation confirming sterility on certain products. Class II Wright Medical Technology, Inc.
Nov 8, 2016 SWANSON FINGER JOINT #1, Part Number 4700001 The firm discovered a lack of adequate documentation confirming sterility on certain products. Class II Wright Medical Technology, Inc.
Nov 8, 2016 Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514 The firm discovered a lack of adequate documentation confirming sterility on certain products. Class II Wright Medical Technology, Inc.
Nov 8, 2016 ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow ... Sterility: Due to a potential incomplete seal on the outer sterile package. Class II Teleflex Medical
Nov 8, 2016 PRO-STIM 10cc INJECTABLE, Part Number 86SR0410 The firm discovered a lack of adequate documentation confirming sterility on certain products. Class II Wright Medical Technology, Inc.
Nov 8, 2016 ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufacture... Sterility: Due to a potential incomplete seal on the outer sterile package. Class II Teleflex Medical
Oct 28, 2016 SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. ... Breach in sterile barrier compromising product sterility Class II Hologic, Inc
Oct 28, 2016 Metzenbaum Scissors 7, Curved, Sterile The Metzenbaum Scissors 7, Curved... The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate c... Class II Integra York PA, Inc
Oct 28, 2016 Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pea... The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate c... Class II Integra York PA, Inc
Oct 20, 2016 Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number S... The sterile packaging may contain small channels in the seal of the pouch, If the channels are p... Class II Micromedics, Inc.
Oct 14, 2016 Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, ... Sterility of the outer surface of the container compromised due to packaging defect. Class II Covidien LLC
Oct 4, 2016 Covidien Clearify Visualization System Item Code: 21-345 Intended to be us... Product sterility is compromised due to breach of the sterile barrier Class II Medtronic
Oct 4, 2016 Best Practices kits containing certain production lots of Clearify Visualizat... Product sterility is compromised due to breach of the sterile barrier Class II Medtronic
Sep 20, 2016 CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syring... Sterility of syringe product could not be assured. Class II Custom Medical Specialties, Inc.
Sep 16, 2016 BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G x 1 (0.6mm x ... BD identified that several lots did not receive the specified dose of irradiation necessary to me... Class II Becton Dickinson & Company
Sep 16, 2016 BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle i... BD identified that several lots did not receive the specified dose of irradiation necessary to me... Class II Becton Dickinson & Company
Sep 16, 2016 BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic ... BD identified that several lots did not receive the specified dose of irradiation necessary to me... Class II Becton Dickinson & Company
Sep 16, 2016 BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2m... BD identified that several lots did not receive the specified dose of irradiation necessary to me... Class II Becton Dickinson & Company
Sep 16, 2016 BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic S... BD identified that several lots did not receive the specified dose of irradiation necessary to me... Class II Becton Dickinson & Company
Sep 16, 2016 BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm... BD identified that several lots did not receive the specified dose of irradiation necessary to me... Class II Becton Dickinson & Company
Sep 16, 2016 BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypode... BD identified that several lots did not receive the specified dose of irradiation necessary to me... Class II Becton Dickinson & Company
Sep 7, 2016 Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula. For Laprosc... Potential lack of assurance of sterility Class II Banyan Medical, LLC
Sep 7, 2016 Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Lapr... Potential lack of assurance of sterility Class II Banyan Medical, LLC
Aug 11, 2016 DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surg... The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe ... Class II DeRoyal Industries Inc
Aug 11, 2016 Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom s... The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe ... Class II DeRoyal Industries Inc
Aug 3, 2016 BARDIA¿ 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD¿ Syringe i... Package Defect: Products may be at risk for having a slit defect on the package and that may affe... Class II C.R. Bard, Inc.
Aug 3, 2016 BARD¿ Piston Syringe, 60cc, Rx Only, Sterile, The BARD¿ Syringe is available ... Package Defect: Products may be at risk for having a slit defect on the package and that may affe... Class II C.R. Bard, Inc.
Aug 3, 2016 BARD¿ Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adap... Package Defect: Products may be at risk for having a slit defect on the package and that may affe... Class II C.R. Bard, Inc.
Aug 3, 2016 BARD¿ 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, Rx Only, T... Package Defect: Products may be at risk for having a slit defect on the package and that may affe... Class II C.R. Bard, Inc.
Aug 2, 2016 Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: T... On December 17, 2015, Greatbatch discovered that the Standard Offset Cup Impactor with a POM-C ha... Class I Greatbatch Medical
Jul 29, 2016 Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start... Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) ... Class II B. Braun Medical, Inc.
Jul 21, 2016 RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that conta... Sterility seal integrity failures on the Renasys Sterile Transparent Film Class II Smith & Nephew, Inc.
Jul 19, 2016 Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used ... Sterility compromised due to breach in sterile packaging Class II Smith & Nephew, Inc.
Jun 27, 2016 CORE¿ Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 ... The packaging seal may contain a crease. The crease may result in an open channel. These channel... Class II ConMed Corporation
Jun 27, 2016 CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe... The packaging seal may contain a crease. The crease may result in an open channel. These channel... Class II ConMed Corporation
Jun 27, 2016 CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual ... The packaging seal may contain a crease. The crease may result in an open channel. These channel... Class II ConMed Corporation
Jun 27, 2016 CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX... The packaging seal may contain a crease. The crease may result in an open channel. These channel... Class II ConMed Corporation
Jun 27, 2016 CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single So... The packaging seal may contain a crease. The crease may result in an open channel. These channel... Class II ConMed Corporation
Jun 27, 2016 CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags, Ca... The packaging seal may contain a crease. The crease may result in an open channel. These channel... Class II ConMed Corporation
Jun 27, 2016 CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single So... The packaging seal may contain a crease. The crease may result in an open channel. These channel... Class II ConMed Corporation
Jun 17, 2016 Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The... Data from internal studies suggests there may be a potential that the secondary package seal inte... Class II Integra LifeSciences Corp.
Jun 13, 2016 Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure o... Potential sterility deficiency. Class II Biomet Microfixation, LLC
Jun 3, 2016 Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, ... Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recomme... Class II Stryker Howmedica Osteonics Corp.
May 10, 2016 Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for... Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal ... Class II CarboFix Orthopedics, Ltd.
May 10, 2016 Double Pump RF Patient Cassette; Product Number: 72204055. Intended to pro... Sterility of device may be compromised due to sterile package breakage. Class II Medical Vision Ab
Apr 26, 2016 Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distribute... Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch i... Class II Greatbatch Medical
Apr 26, 2016 Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: ... Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch i... Class II Greatbatch Medical
Apr 26, 2016 Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, N... Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch i... Class II Greatbatch Medical
Mar 31, 2016 Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical 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.