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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

2,447 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,447 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 2,447 FDA device recalls.

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DateProductReasonClassFirm
Apr 1, 2019 Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Nu... Pin hole package failures compromising sterility of product Class II Dornier Medtech America, Inc.
Mar 30, 2019 Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only,... Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is in... Class II Thoratec Corp.
Mar 30, 2019 Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 1055... Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is in... Class II Thoratec Corp.
Mar 28, 2019 Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, ... Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of ballo... Class I Edwards Lifesciences, LLC
Mar 28, 2019 Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx... Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of ballo... Class I Edwards Lifesciences, LLC
Mar 12, 2019 PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intende... VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales ... Class II Ethicon, Inc.
Mar 1, 2019 Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an opti... Small black plastic particle was observed in the left ventricle during implant procedure. Class II Thoratec Corp.
Feb 22, 2019 Paltop 1.25 Hex Drivers, Long Part Number: 60-70101 Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving... Class II Keystone Dental Inc
Feb 22, 2019 Paltop 1.25 Hex Drivers, Short Part Number: 60-70102 Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving... Class II Keystone Dental Inc
Feb 22, 2019 Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgi... Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving... Class II Keystone Dental Inc
Feb 22, 2019 Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical an... Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving... Class II Keystone Dental Inc
Feb 21, 2019 icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Ad... There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... Class I ICU Medical, Inc.
Feb 21, 2019 icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). ... There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... Class I ICU Medical, Inc.
Feb 21, 2019 icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Gradu... There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... Class I ICU Medical, Inc.
Feb 21, 2019 icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV admin... There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... Class I ICU Medical, Inc.
Feb 21, 2019 icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV admini... There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... Class I ICU Medical, Inc.
Feb 21, 2019 SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administr... There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... Class I ICU Medical, Inc.
Feb 21, 2019 icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) ... There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... Class I ICU Medical, Inc.
Feb 18, 2019 LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCUL... Certain product code/lot number combinations may experience introducer sheath compatibility issu... Class II Bard Peripheral Vascular Inc
Jan 22, 2019 COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002 There is a potential for patients undergoing ablation to experience an elevated risk for TE; duri... Class II AtriCure, Inc.
Jan 22, 2019 COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001 There is a potential for patients undergoing ablation to experience an elevated risk for TE; duri... Class II AtriCure, Inc.
Jan 22, 2019 COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S There is a potential for patients undergoing ablation to experience an elevated risk for TE; duri... Class II AtriCure, Inc.
Jan 22, 2019 COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI There is a potential for patients undergoing ablation to experience an elevated risk for TE; duri... Class II AtriCure, Inc.
Jan 14, 2019 TRINIAS for diagnostic imaging and interventional procedures in cardiac angio... Two issues: Event 1: Normal operation of the device is to power up the device in the morning, ... Class II Shimadzu Medical Systems Usa Com
Jan 14, 2019 Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices ar... Devices may generate excessive heat during use. Class II Arthrex, Inc.
Jan 9, 2019 Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usag... An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. Class II ConvaTec, Inc
Jan 3, 2019 icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed Sy... There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate Class I ICU Medical, Inc.
Dec 28, 2018 16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Produc... The firm had a report of doctors being unable to pull the obstetric forceps apart. Class II Fetzer Medical GmbH & Co. KG
Dec 28, 2018 12002 / Boss Instruments Ltd. Wrigley Obstetric Forceps, 11" (28cm), Item No.... The firm had a report of doctors being unable to pull the obstetric forceps apart. Class II Fetzer Medical GmbH & Co. KG
Dec 28, 2018 16600 / Fetzer Surgical Luikart Simpson OB Forceps14" (35.5cm), Item No./Prod... The firm had a report of doctors being unable to pull the obstetric forceps apart. Class II Fetzer Medical GmbH & Co. KG
Dec 28, 2018 12002 / Boss Instruments Simpson OB Forceps, short model, 13" (33cm), Item No... The firm had a report of doctors being unable to pull the obstetric forceps apart. Class II Fetzer Medical GmbH & Co. KG
Dec 19, 2018 ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800 Inability or difficulty in unbuckling/releasing the proning arm buckle might delay patient access... Class II Arjohuntleigh Magog
Dec 19, 2018 Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, ... There is a potential for difficulty in sliding down the retention mechanism on the sets manufactu... Class II Cook Inc.
Dec 19, 2018 Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, ... There is a potential for difficulty in sliding down the retention mechanism on the sets manufactu... Class II Cook Inc.
Dec 7, 2018 LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (... The reaming guide and the guide rod can't be screwed into the intended depth. The reason for this... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Dec 6, 2018 VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE)... VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may ex... Class II Carl Zeiss Meditec, Inc.
Nov 27, 2018 ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp... Reports of pressure tubing separation between the sampling port and the high pressure tubing on c... Class II ICU Medical, Inc.
Nov 27, 2018 ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp... Reports of pressure tubing separation between the sampling port and the high pressure tubing on c... Class II ICU Medical, Inc.
Nov 27, 2018 ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp... Reports of pressure tubing separation between the sampling port and the high pressure tubing on c... Class II ICU Medical, Inc.
Nov 20, 2018 Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product... One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking... Class II Zimmer Biomet, Inc.
Nov 20, 2018 Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Produ... One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking... Class II Zimmer Biomet, Inc.
Nov 19, 2018 Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600... HVAD Battery Charger units manufactured with wrong inductors. Class II Heartware, Inc.
Nov 8, 2018 SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 I... There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow... Class II ICU Medical Inc
Nov 1, 2018 The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardiov... Experienced accelerated battery depletion and a shortened replacement interval due to latent inte... Class II Boston Scientific Corporation
Oct 31, 2018 Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product C... This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dua... Class II COVIDIEN LLC
Oct 31, 2018 Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.0... Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller ... Class II Zimmer GmbH
Oct 15, 2018 Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, ... There is a potential for the male connectors on external cables to become damaged. This could inc... Class II Jarvik Heart Inc
Oct 10, 2018 Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage:... Automated external defibrillators may not fully meet IPx5 water ingress specification. The device... Class II Philips Electronics North America Corp.
Oct 5, 2018 Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 u... Potential for leakage due to defect in the thermoset check valve component. Class II ICU Medical, Inc.
Oct 5, 2018 Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per... Potential for leakage due to defect in the thermoset check valve component. Class II ICU Medical, 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.