Browse Device Recalls

638 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 638 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 638 FDA device recalls.

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DateProductReasonClassFirm
Feb 20, 2024 Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilit... Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Int... Class II Boston Scientific Corporation
Feb 20, 2024 EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutri... Inability to advance the guidewire through the feeding tube during placement due to blocked lumen... Class II Boston Scientific Corporation
Feb 20, 2024 EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nut... Inability to advance the guidewire through the feeding tube during placement due to blocked lumen... Class II Boston Scientific Corporation
Feb 20, 2024 Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0... An investigation determined that delivery of the Obsidio embolic using the aliquot technique for ... Class I Boston Scientific Corporation
Feb 20, 2024 EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutr... Inability to advance the guidewire through the feeding tube during placement due to blocked lumen... Class II Boston Scientific Corporation
Feb 12, 2024 Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050 Boston Scientific has identified a tooling error in manufacturing which may have caused delaminat... Class I Boston Scientific Corporation
Dec 19, 2023 EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 ... Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replac... Class II Boston Scientific Corporation
Nov 30, 2023 Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) ... The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generator... Class II Boston Scientific Corporation
Sep 27, 2023 EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inne... Poor image quality due to fluid ingress in the lens. Class II Boston Scientific Corporation
Sep 27, 2023 EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box U... Poor image quality due to fluid ingress in the lens. Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M00310142... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M00310143... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M00310146... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M00310162... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M00310144... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M00310148... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M00310147... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M00310163... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 11, 2023 EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardiov... There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, w... Class II Boston Scientific Corporation
Jul 11, 2023 EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverte... There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, w... Class II Boston Scientific Corporation
May 25, 2023 Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device... Manufactured with the incorrect component may result in lower power output and degradation or dim... Class II Boston Scientific Corporation
May 25, 2023 Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device th... Manufactured with the incorrect component may result in lower power output and degradation or dim... Class II Boston Scientific Corporation
May 25, 2023 Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser ... Manufactured with the incorrect component may result in lower power output and degradation or dim... Class II Boston Scientific Corporation
May 25, 2023 Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device tha... Manufactured with the incorrect component may result in lower power output and degradation or dim... Class II Boston Scientific Corporation
May 25, 2023 Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser ... Manufactured with the incorrect component may result in lower power output and degradation or dim... Class II Boston Scientific Corporation
May 25, 2023 Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a ... Manufactured with the incorrect component may result in lower power output and degradation or dim... Class II Boston Scientific Corporation
May 25, 2023 Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a d... Manufactured with the incorrect component may result in lower power output and degradation or dim... Class II Boston Scientific Corporation
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

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.