Browse Device Recalls

126 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 126 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 126 FDA device recalls.

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DateProductReasonClassFirm
Aug 30, 2024 The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable st... Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instruct... Class II Stryker Neurovascular
Apr 23, 2024 Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Cata... Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... Class II Stryker Neurovascular
Apr 23, 2024 FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495 Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... Class II Stryker Neurovascular
Apr 23, 2024 Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3... Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... Class II Stryker Neurovascular
Apr 23, 2024 Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2... Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... Class II Stryker Neurovascular
Apr 23, 2024 DAC 044 115cm, Catalog: 90760 Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... Class II Stryker Neurovascular
Apr 23, 2024 Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wi... Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... Class II Stryker Neurovascular
Apr 23, 2024 Trevo Trak 21 Microcatheter, Catalog: 90338 Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... Class II Stryker Neurovascular
Apr 23, 2024 Trevo ProVue, Catalog: 90184 Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... Class II Stryker Neurovascular
Apr 18, 2024 The Synchro Neuro Guidewires are a steerable guidewire family with a shapeabl... Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the... Class II Stryker Neurovascular
Apr 18, 2024 The Synchro SELECT Guidewires are a steerable guidewire family with a shapeab... Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the... Class II Stryker Neurovascular
Apr 18, 2024 The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip... Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the... Class II Stryker Neurovascular
Apr 3, 2024 The Distal Access Catheter is a single-lumen, braided shaft, variable stiffne... Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access... Class II Stryker Neurovascular
Dec 6, 2023 Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm The microcatheter IFU contains an intended use that has not been evaluated by the FDA. Class II Stryker, Inc.
Dec 6, 2023 Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm The microcatheter IFU contains an intended use that has not been evaluated by the FDA. Class II Stryker, Inc.
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
Jun 3, 2022 Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE... Microcatheter product label on the carton is missing the microcatheter product drawing/illustration. Class II Stryker Neurovascular
Sep 21, 2020 Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM... Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever ... Class I Stryker Neurovascular
Apr 18, 2019 Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO,... A design related issue can contribute to the device exhibiting brittle behavior. This behavior ma... Class II Stryker Neurovascular
Apr 10, 2019 Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC... The firm has become aware of a potential problem that their Catheters may break/fracture and/or k... Class II Stryker Neurovascular
Apr 10, 2019 Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC... The firm has become aware of a potential problem that their Catheters may break/fracture and/or k... Class II Stryker Neurovascular
Nov 13, 2018 Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE ... Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter pa... Class II Stryker Neurovascular
Jun 8, 2018 Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coatin... The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... Class II Stryker Neurovascular
Jun 8, 2018 Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Produ... Class II Stryker Neurovascular
Jun 8, 2018 Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coa... The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... Class II Stryker Neurovascular
Jun 8, 2018 Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Pro... The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... Class II Stryker Neurovascular
Jun 8, 2018 Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coat... The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... Class II Stryker Neurovascular
Jun 8, 2018 Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Pr... The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... Class II Stryker Neurovascular
Jun 8, 2018 Synchro2, 0.014in. x 300cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coatin... The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... Class II Stryker Neurovascular
Jun 8, 2018 Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Prod... The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... Class II Stryker Neurovascular
Jun 5, 2018 Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0... Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported Class II Stryker Neurovascular
May 2, 2018 AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x... The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded. Class II Stryker Neurovascular
Apr 11, 2018 FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm... There may be product manufactured with the outer diameter of the balloon catheter exceeding the d... Class II Stryker Neurovascular
Nov 28, 2017 Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm an... Stryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue System was manufactu... Class II Stryker Neurovascular
Nov 3, 2017 Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 m... Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Pac... Class II Stryker Neurovascular

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.