Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

78 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 78 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 78 FDA device recalls.

Clear
DateProductReasonClassFirm
Apr 24, 2020 AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Ele... Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes t... Class II Angiodynamics, Inc.
Nov 19, 2019 MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - Product Usage: pre... May result in readings outside of the expected accuracy range. Class II Angiodynamics, Inc.
Nov 19, 2019 MICRO-PSD Electron, Catalog Number: PSD-EE5N - Product Usage: pre-calibrated ... May result in readings outside of the expected accuracy range. Class II Angiodynamics, Inc.
Nov 19, 2019 MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD s... May result in readings outside of the expected accuracy range. Class II Angiodynamics, Inc.
Nov 19, 2019 OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Us... May result in readings outside of the expected accuracy range. Class II Angiodynamics, Inc.
Nov 19, 2019 OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Numbe... May result in readings outside of the expected accuracy range. Class II Angiodynamics, Inc.
Jun 27, 2019 AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .01... The affected product is properly labelled with an expiration date of March 31, 2022; but the RFID... Class II Angiodynamics, Inc.
Sep 22, 2017 Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 c... Product was placed into distribution prior to completion of all required post sterilization relea... Class II Angiodynamics, Inc.
Jun 5, 2017 Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN)... The firm is recalling product that has the potential to not function during use. The product af... Class II Angiodynamics, Inc.
Jun 5, 2017 Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H78... The firm is recalling product that has the potential to not function during use. The product af... Class II Angiodynamics, Inc.
Jun 5, 2017 Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601-US, Model # (UPN) ... The firm is recalling product that has the potential to not function during use. The product af... Class II Angiodynamics, Inc.
Jun 5, 2017 Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (U... The firm is recalling product that has the potential to not function during use. The product af... Class II Angiodynamics, Inc.
Jun 5, 2017 Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (... The firm is recalling product that has the potential to not function during use. The product af... Class II Angiodynamics, Inc.
Jun 5, 2017 Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US, Model ... The firm is recalling product that has the potential to not function during use. The product af... Class II Angiodynamics, Inc.
Sep 28, 2016 ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catal... Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... Class III Angiodynamics, Inc.
Sep 28, 2016 ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F ... Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... Class III Angiodynamics, Inc.
Sep 28, 2016 ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F ... Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... Class III Angiodynamics, Inc.
Sep 28, 2016 ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F ... Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... Class II Angiodynamics, Inc.
Sep 28, 2016 ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F ... Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... Class III Angiodynamics, Inc.
Sep 28, 2016 ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F ... Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... Class III Angiodynamics, Inc.
Sep 28, 2016 ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F ... Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... Class III Angiodynamics, Inc.
Sep 7, 2016 Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the f... The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Aug 6, 2014 Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Patter... AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to ... Class II Angiodynamics, Inc.
Aug 6, 2014 Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Patter... AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to ... Class II Angiodynamics, Inc.
Aug 6, 2014 Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Patter... AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to ... Class II Angiodynamics, Inc.
Apr 30, 2013 AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following ... AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kit... Class II Angiodynamics, Inc.
Apr 30, 2013 AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioD... AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kit... Class II Angiodynamics, Inc.
Jun 15, 2012 AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size:... AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter ... Class II Angiodynamics Worldwide Headquarters

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.