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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF ... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H749... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H749... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H749... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), RE... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H7490... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H749... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H749... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H749... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 21, 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), ... | An increase in complaints related to an inability to advance the guidewire through the lumen of t... | Class I | Boston Scientific Corporation |
| Mar 5, 2024 | OptiCross Coronary Imaging Catheter, REF H749518080120 | Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect vo... | Class II | Boston Scientific Corporation |
| Feb 20, 2024 | EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition dir... | 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 (Box 2)-Indicated for enteral nutrition d... | Inability to advance the guidewire through the feeding tube during placement due to blocked lumen... | Class II | Boston Scientific Corporation |
| 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 |
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.