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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

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

Clear
DateProductReasonClassFirm
May 10, 2018 5F DL BIOFLO PICC, Catalog Number 60M180592 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 microTargeting" Drive System, Product Number 66-ZD-MD The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage... Hyalomatrix products are susceptible to degradation as a result of the decomposition of PVC in th... Class II Anika Therapeutics, Inc.
May 10, 2018 RS TANDEM 5F DL XPP, Catalog Number 60M019881 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 microTargeting" Drive System, Product Number MT-DS The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Nu... A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 RS 5F DL BIOFLO PASV, Catalog Number 60M132324 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 5F DL BIOFLO PASV, Catalog Number 60M141006 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 CAN 5F SINGLE XCELA PICC, Catalog Number 60M701531 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 9, 2018 VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diag... There is a potential for imprecise results when using the slides. Increase in imprecision when u... Class II Ortho-Clinical Diagnostics
May 9, 2018 ImagePilot, Model No. D9MA Panasonic has issued a Mandatory Product Safety Notice, indicating a possibility of battery ignit... Class II Konica Minolta Medical Imaging USA, Inc.
May 9, 2018 Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Produ... There is a potential for a different set to be mixed within the lot, where the incorrect set does... Class II B. Braun Medical, Inc.
May 9, 2018 OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.... Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specificall... Class II Johnson & Johnson Surgical Vision Inc
May 9, 2018 CS-7, Model No. A4C1 Panasonic has issued a Mandatory Product Safety Notice, indicating a possibility of battery ignit... Class II Konica Minolta Medical Imaging USA, Inc.
May 8, 2018 Reprocessed HARMONIC Ace¿ +7, 5mm Diameter Shears with Advanced Hemostasis (H... Stryker Sustainability Solutions has received an increase in reports indicating that the affected... Class II Stryker Sustainability Solutions
May 8, 2018 MX-10 surveillance laser system Product Usage: The expected usage of the ... Product has a nominal ocular hazard distance (NOHD) that is longer than specified and persons cou... Class II Wescam Inc
May 8, 2018 Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: ... Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool. Class III Human Design Medical Llc
May 8, 2018 ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Dev... Replacement of units lacking an updated device approval. Class II MEDTECH SAS
May 8, 2018 Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightS... In certain eyepiece configurations the laser shutter may not close completely, permitting reflect... Class II Zeiss, Carl Inc
May 8, 2018 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), inf... The firm will be updating the Instructions for Use for the product. Current IFUs instruct users t... Class II Baxter Healthcare Corporation
May 8, 2018 Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identific... Elevated false positive results Yersinia enterocolitica (Yersinia) from customers using the EP Nu... Class II Luminex Corporation
May 8, 2018 AirLife Resuscitation Device, Pediatric labeled as the following: a. Ped... An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct... Class I Vyaire Medical
May 8, 2018 AirLife Resuscitation Device, Adult labeled as the following: a. Adult, ... An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct... Class I Vyaire Medical
May 8, 2018 Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DI... The device is equipped with a dial that has an inaccurate flow rate indicator. Class II Dynarex Corporation
May 8, 2018 Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total... Potentially have non-conforming internal threads. Class II Exactech, Inc.
May 8, 2018 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), inf... The firm will be updating the Instructions for Use for the product. Current IFUs instruct users t... Class II Baxter Healthcare Corporation
May 7, 2018 PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6... Some left-handed gloves contain powder. Powdered surgical gloves are a banned medical device in t... Class II WRP Asia Pacific Sdn Bhd
May 7, 2018 PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PRONOVA SUTURE BLUE 122CM M1.5, D10189 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 cobas m 511 integrated hematology analyzer, Model Number 07261691190 Produ... Discrepant results have been reported in patients with severe microcytic anemia (e.g.iron deficie... Class II Roche Diagnostics Hematology
May 7, 2018 PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. ... The recalling firm has identified two lots of test strips that are out of specification. Affected... Class II Roche Diabetes Care, Inc.
May 7, 2018 PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos... The recalling firm identified four US lots of test strips out of specification. Affected strips s... Class II Roche Diabetes Care, Inc.
May 7, 2018 PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 0... The recalling firm has identified two lots of test strips that are out of specification. Affected... Class II Roche Diabetes Care, Inc.
May 7, 2018 PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, 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.