Browse Device Recalls
22 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 22 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 22 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 4, 2025 | Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm ... | product mix-up; Vascular stent labeled as one size but contains a different size. | Class II | Cordis US Corp |
| Mar 4, 2025 | Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm ... | product mix-up; Vascular stent labeled as one size but contains a different size. | Class II | Cordis US Corp |
| Feb 7, 2025 | Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. G... | Catheter manufactured at the incorrect length. | Class II | Cordis US Corp |
| Nov 28, 2023 | MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femor... | Cordis became aware that the label for the carton box containing 10 units is incorrect for some b... | Class II | Cordis US Corp |
| Nov 28, 2023 | MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral ... | Cordis became aware that the label for the carton box containing 10 units is incorrect for some b... | Class II | Cordis US Corp |
| Sep 26, 2023 | Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208,... | Non-sterile product labeled as sterile was distributed. | Class I | Cordis US Corp |
| Mar 24, 2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... | Class I | Cordis US Corp |
| Mar 24, 2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... | Class I | Cordis US Corp |
| Mar 24, 2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... | Class I | Cordis US Corp |
| Mar 24, 2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... | Class I | Cordis US Corp |
| Mar 24, 2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... | Class I | Cordis US Corp |
| Mar 24, 2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... | Class I | Cordis US Corp |
| Mar 24, 2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... | Class I | Cordis US Corp |
| Mar 24, 2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... | Class I | Cordis US Corp |
| Mar 24, 2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... | Class I | Cordis US Corp |
| Mar 24, 2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... | Class I | Cordis US Corp |
| Mar 24, 2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... | Class I | Cordis US Corp |
| Mar 24, 2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... | Class I | Cordis US Corp |
| Mar 24, 2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... | Class I | Cordis US Corp |
| Mar 24, 2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... | Class I | Cordis US Corp |
| Nov 7, 2022 | Cordis Angiographic Catheter Extensions. Used to transport fluid from th... | There is a potential for separation at the male connector. | Class II | Cordis US Corp |
| May 20, 2022 | PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, ... | Potential for stent dislodgement and associated failures related to two specific sizes of the dev... | Class II | Cordis US Corp |
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.