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Browse Device Recalls

603 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 603 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 603 FDA device recalls.

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DateProductReasonClassFirm
Apr 5, 2023 WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H749... The firm received complaints of the Insertion Tool component being occluded, resulting in the ina... Class II Boston Scientific Corporation
Apr 5, 2023 WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H749393... The firm received complaints of the Insertion Tool component being occluded, resulting in the ina... Class II Boston Scientific Corporation
Feb 2, 2023 LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Sof... Under specific circumstances, the U.S. product registration system did not send up enablement req... Class II Boston Scientific Corporation
Feb 2, 2023 Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequen... Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due t... Class II Boston Scientific Corporation
Oct 13, 2022 EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, wh... Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU. Class II Boston Scientific Corporation
Oct 10, 2022 ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscop... ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body re... Class II Boston Scientific Corporation
Oct 10, 2022 ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastroi... ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body re... Class II Boston Scientific Corporation
Oct 10, 2022 ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal end... ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body re... Class II Boston Scientific Corporation
Sep 30, 2022 EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile. There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate... Class II Boston Scientific Corporation
Sep 30, 2022 EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile. There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate... Class II Boston Scientific Corporation
Aug 9, 2022 Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440 The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve... Class II Boston Scientific Corporation
Jul 7, 2022 The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the Z... There is potential for unanticipated software anomalies to occur when using the Model 2868 Applic... Class II Boston Scientific Corporation
Jul 7, 2022 The PRM is intended to be used as part of the ZOOM LATITUDE Programming Syste... There is potential for unanticipated software anomalies to occur when using the Model 2868 Applic... Class II Boston Scientific Corporation
Jul 7, 2022 The PRM is intended to be used as part of the ZOOM LATITUDE Programming Syste... There is potential for unanticipated software anomalies to occur when using the Model 2868 Applic... Class II Boston Scientific Corporation
May 31, 2022 GreenLight HPSEA Laser Fibers, UPN 0010-2092 Several complaints were received for the affected lot; users received a "Fiber type does not matc... Class III Boston Scientific Corporation
May 25, 2022 EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged a... Product may be mislabeled. Class II Boston Scientific Corporation
May 25, 2022 EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged a... Product may be mislabeled. Class II Boston Scientific Corporation
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 3, 2022 EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended U... Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known... Class II Boston Scientific Corporation
Mar 3, 2022 EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Us... Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known... Class II Boston Scientific Corporation
Mar 3, 2022 EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended ... Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known... Class II Boston Scientific Corporation
Mar 3, 2022 EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended ... Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known... Class II Boston Scientific Corporation
Feb 24, 2022 SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position t... Users need to be aware that embolism is a possible adverse event associated with hydrogel misplac... Class II Boston Scientific Corporation
Feb 24, 2022 SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to tempora... Users need to be aware that embolism is a possible adverse event associated with hydrogel misplac... Class II Boston Scientific Corporation
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.