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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 21, 2016 | GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033... | The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils. | Class II | Stryker Neurovascular |
| Oct 22, 2014 | Target 360 Standard 12mm x 30cm; Target Detachable Coils are intended to e... | Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers... | Class II | Stryker Neurovascular |
| Oct 22, 2014 | GDC-18 360 20mm x 33cm ; GDC 360¿ Detachable Coils are intended for emboli... | Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers... | Class II | Stryker Neurovascular |
| Oct 22, 2014 | GDC-10 360 10mm x 30cm SR ; GDC 360¿ Detachable Coils are intended for emb... | Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers... | Class II | Stryker Neurovascular |
| Oct 22, 2014 | GDC-10 360 SOFT 3mm x 6cm SR ; GDC 360¿ Detachable Coils are intended for ... | Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers... | Class II | Stryker Neurovascular |
| Oct 22, 2014 | Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated fo... | Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand EXCELSIOR SL-10 PRE-SHAPED C 15OCM; Catalog Number: M0031441940... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand EXCELSIOR 1018 PRE-SHAPED 45 150CM, Catalog Number: M0031441900... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand COMPLIANT 4MM X 15MM, Catalog Number: M003SRC04150; Product is... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand EXCELSIOR SL-10 PRE-SHAPED 90 150CM, Catalog Number: M003168191... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand SUPER COMPLIANT 4MM X 7MM, Catalog Number: M003SSC04070; Prod... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand EXCELSIOR SL-10 PRE-SHAPED S 15OCM; Catalog Number: M0031441920... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand GDC VORTX 2MM X 3MM, Catalog Number: M00335302340; Product is ... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand COMPLIANT 5MM X 15MM, Catalog Number: M003SRC05150; Product i... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand EXCELSIOR SL-10 PRE-SHAPED 45 150CM, Catalog Number: M003168190... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM; Catalog Number: M0031441930... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM, Catalog Number: M0031681920... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand GDC-10 ULTRA SOFT 2MM X 3CM, Catalog Number: M0033432030; Pro... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand COMPLIANT 4MM X 10MM, Catalog Number: M003SRC04100; Product is... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand COMPLIANT 5MM X 30MM, Catalog Number: M003SRC05300; Product i... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand COMPLIANT 4MM X 20MM, Catalog Number: M003SRC04200; Product is... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand GDC-18 360 18MM X 30CM, Catalog Number: M00334818300; Product... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand EXCELSIOR SL-10 150CM 2 TIP, Catalog Number: M0031681890, Produ... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand SUPER COMPLIANT 7MM X 15MM, Catalog Number: M003SSC07150; Pro... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand COMPLIANT 4MM X 30MM, Catalog Number: M003SRC04300; Product is... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Jun 24, 2013 | Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Cat... | The device is labeled incorrectly, in that, the device Model Number on the outer carton and inner... | 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.