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Browse Device Recalls

3,037 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,037 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 3,037 FDA device recalls.

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DateProductReasonClassFirm
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-1... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jun 2, 2022 YelloPort Elite Universal Seal. For use in laparoscopic procedures. There is the potential that YelloPort Elite Universal Seals packaging may contain small holes whi... Class II Surgical Innovations Ltd
Apr 20, 2022 The C304-HIS device features a guide wire to access the vein, a valve to redu... The firm's internal processes identified that certain lots may have an improperly sealed barrier ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 18, 2022 progenamatrix Human Keratin Matrix, sterile, Rx, with the following model num... Inner pouch seal may be inadequate resulting in lack of sterility. Class II ProgenaCare
Apr 8, 2022 XVIVO Organ Chamber REF 19020 The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ens... Class II XVIVO PERFUSION AB
Apr 8, 2022 Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU elect... Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product. Class II Radiometer Medical ApS
Apr 6, 2022 TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only, Potential breach in the sterility barrier for tray ring covers. Class II Johnson & Johnson Surgical Vision Inc
Apr 1, 2022 VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a... Products in this lot may have compromised barrier seals, introducing a risk to sterility. Class II CooperSurgical, Inc.
Mar 23, 2022 Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO... Packaging for Balloon Catheters may be damaged resulting in loss of sterility. Class II Medtronic Vascular, Inc.
Mar 23, 2022 Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV0600800... Packaging for Balloon Catheters may be damaged resulting in loss of sterility. Class II Medtronic Vascular, Inc.
Mar 8, 2022 ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support Pouch seals may be open, compromising sterility. Class II Boston Scientific Corporation
Mar 8, 2022 ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy Pouch seals may be open, compromising sterility. Class II Boston Scientific Corporation
Mar 4, 2022 Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride In... Sterility failure of the exterior of the syringe which may impact the device's ability to be laid... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 25, 2022 Lum Lam Custom Pack - Anesthesia Kit The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. Class II Stradis Medical, LLC dba Stradis Healthcare
Feb 25, 2022 Total Knee Pack - Surgical Kit The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. Class II Stradis Medical, LLC dba Stradis Healthcare
Feb 25, 2022 Anterior Hip Pack - Surgical Kit The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. Class II Stradis Medical, LLC dba Stradis Healthcare
Feb 25, 2022 Surgicare Neuro Pack - Neurological Kit The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. Class II Stradis Medical, LLC dba Stradis Healthcare
Feb 25, 2022 Coryell Memorial Hosp Total, Joint Pack - Surgical Kit The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. Class II Stradis Medical, LLC dba Stradis Healthcare
Jan 17, 2022 OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE,... The sterile pouch seal may contain channels that could affect the seal integrity and potentially ... Class II Lacrimedics Inc
Jan 17, 2022 Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE... The sterile pouch seal may contain channels that could affect the seal integrity and potentially ... Class II Lacrimedics Inc
Jan 7, 2022 NavitrackER Kit A: Knee, Model Number 20-8000-000-07, The product was released for distribution without passing sterilization results, which could pote... Class II Orthosoft, Inc. dba Zimmer CAS
Dec 22, 2021 HYDRATOME RX 44-30MM/260CM Material Number: M00583050 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 49-30-260-035 Material Number: M00573020 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 49-30-450-035 Material Number: M00573030 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material N... Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 DREAMTOME 49-20MM/450CM Material Number: M00584020 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 39-20-260-025 Material Number: M00573080 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 HYDRATOME RX 44-30MM/450CM Material Number: M00583070 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 39-30-260-025 Material Number: M00573100 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 44-20-450-035 Material Number: M00573050 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 44-30-450-035 Material Number: M00573070 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 39-30-450-025 Material Number: M00573110 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 44-30-260-035 Material Number: M00573060 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00... Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 HYDRATOME RX 49-30MM/260CM Material Number: M00583010 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Num... Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 DREAMTOME 49-30MM/260CM Material Number: M00584010 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 HYDRATOME RX 44-20MM/260CM Material Number: M00583040 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 ... Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 DREAMTOME 44-30MM/450CM Material Number: M00584070 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 49-20-260-035 Material Number: M00573000 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 DREAMTOME 49-30MM/450CM Material Number: M00584030 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 DREAMTOME 49-20MM/260CM Material Number: M00584000 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation

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.