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Browse Device Recalls

235 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 235 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 235 FDA device recalls.

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DateProductReasonClassFirm
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL3.5, 110CM, 070", REF SA6JL35A. fo... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F 3DRIGHT SH .070", REF SA63DRIGHTSH. f... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5, .070", REF SA6EBU35. for card... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC4.0 SH, .070", REF SA6MAC40SH. for... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F MP2, .070", REF SA6MP2. for cardiovas... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, LCB SH, 90CM, 070", REF SA6LCBSHD. f... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR3.5 SH, .070", REF SA6ECR35SH. for... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F JR6.0 SH, .070", REF SA6JR60SH. for c... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F SL3.0, .070", REF SA6SL30. for cardio... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0 SH, .070", REF SA6JL40SH. for c... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F SR3.5, .070" REF SA6SR35. for cardiov... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC 3.5, .070", REF SA6MAC35. for car... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F JR6.0, .070", REF SA6JR60. for cardio... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL3.0 110CM.070", REF SA6AL30A. for ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA SH, 100CM, 070", REF SA6IMASH. f... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.5 SH, .070", REF SA6AL15SH. for c... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 90CM.070", REF SA6EBU35D. fo... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 30o, .070", REF SA6MAC3030. fo... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F HSIII SH, .070", REF SA6HSIIISH. for ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F MP1, .070", REF SA6MP1. for cardiovas... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.5 SH, .070", REF SA6EBU45SH. for... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT, LONG TIP, .070", REF SA6ERAD... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP3.0, .070", REF SA6CHAMP30. for ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP2.0, .070", REF SA6CHAMP20. for ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, MB1, 90CM, 070", REF SA6MB1D. for ca... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR4.0 SH, .070", REF SA6ECR40SH. for... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F RCB, .070", REF SA6RCB. for cardiovas... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP0.5, 100CM.070", REF SA6CHAMP05. ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.5 SH, .070", REF SA6JL45SH. for c... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC4.0, .070", REF SA6MAC40. for card... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, PK1, 47CM, 070", REF SA6PK1W. for ca... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F M RADIAL, .070", REF SA6MRADIAL. for ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F EL GAMAL SH, .070", REF SA6ELGAMALSH. ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.5, .070", REF SA6SAL15. for card... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F ALR1-2 SH, .070", REF SA6ALR12SH. for... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT, .070", REF SA6ERADL. for c... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.5, .070", REF SA6EBU45. for card... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP3.5, .070", REF SA6CHAMP35. for ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC5.0, .070", REF SA6MAC50. for card... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR3.5 SH, .070", REF SA6SCR35SH. for... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.5, .070", REF SA6RBU45. for card... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F SR3.5 SH, .070" REF SA6SR35SH. for ca... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F AL3.0, .070", REF SA6AL30. for cardio... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP2.0, 55CM.070", REF SA6CHAMP20K. ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5 SH, .070", REF SA6EBU35SH. for... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75, .070", REF SA6SAL75. for card... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.0 SH, .070", REF SA6CHAMP10SH. ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, RDND1 55CM .070", REF SA6RDND1K. for... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.0, .070", REF SA6SL40. for cardio... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F LARA, .070", REF SA6LARA. for cardiov... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular

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.