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Browse Device Recalls

3,461 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,461 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 3,461 FDA device recalls — Class I.

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DateProductReasonClassFirm
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F HSII, .070", REF SA6HSII. 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 EBU3.75 SH, .070", REF SA6EBU375SH. 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 CHAMP1.0, .070", REF SA6CHAMP10. 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, JR4.0, 55CM, 070", REF SA6JR40K. 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 SH, .070", REF SA6RCBSH. 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 SL3.5, .070", REF SA6SL35. 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 JR3.5, .070", REF SA6JR35. 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 MP1 SH, .070", REF SA6MP1SH. 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 M RESS, .070", REF SA6MRESS. 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, AL.75 110CM.070", REF SA6AL75A. 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 AL2.5, .070:, REF SA6AL25. 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 ALR1-2, .070", REF SA6ALR12. 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 JL4.0, .070", REF SA6JL40. 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, AR2.0 SH, 100CM.070", REF SA6AR20SH. ... 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 SAL3.0, .070", REF SA6SAL30. 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, HSI, 100CM, 070", REF SA6HSI. 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 ERAD LEFT SH, .070", REF SA6ERADLSH. ... 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, RBU3.5, 100CM, 070", REF SA6RBU35. 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 RBU4.0 SH, .070", REF SA6RBU40SH. 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, NOTO, 100CM, 070", REF SA6NOTO. 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, AL1.0 110CM .070", REF SA6AL10A. 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, AR1.0 100CM.070", REF SA6AR10. 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 JL4.5, .070", REF SA6JL45. 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, AR1.0SH 100CM.070", REF SA6AR10SH. 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 MP ST, .070", REF SA6MPST. 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 LCB SH, .070", REF SA6LCBSH. 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, RCB SH, 90CM, 070", REF SA6RCBSHD. 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, AR2.0, 100CM.070", REF SA6AR20. for ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 13, 2019 enFlow Disposable Cartridge, used for intravenous warming therapy with fluid ... Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming. Class I Vyaire Medical
Mar 13, 2019 enFlow Disposable Cartridge with IV Extension Set, used for intravenous warmi... Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warm... Class I Vyaire Medical
Feb 28, 2019 SmartSite Syringe Administration Set-Product Package Size 50, Catalog Numbe... Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infu... Class I Becton Dickinson & Company
Feb 27, 2019 Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software ... In certain occurrences, the affected navigation software application might unexpectedly display a... Class I Brainlab AG
Feb 21, 2019 icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) ... There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... Class I ICU Medical, Inc.
Feb 21, 2019 SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administr... There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... Class I ICU Medical, Inc.
Feb 21, 2019 icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV admini... There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... Class I ICU Medical, Inc.
Feb 21, 2019 icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV admin... There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... Class I ICU Medical, Inc.
Feb 21, 2019 icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Gradu... There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... Class I ICU Medical, Inc.
Feb 21, 2019 icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). ... There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... Class I ICU Medical, Inc.
Feb 21, 2019 icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Ad... There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... Class I ICU Medical, Inc.
Feb 12, 2019 e700 Automatic Transport Ventilator, Model Number 01EVE700 There is a potential for the unit to catch fire due to one of the screen retaining screws being i... Class I O-Two Medical Technologies, Inc.
Feb 12, 2019 e600 Automatic Transport Ventilator, Model Number 01EVE600 There is a potential for the unit to catch fire due to one of the screen retaining screws being i... Class I O-Two Medical Technologies, Inc.
Feb 12, 2019 e500 Automatic Transport Ventilator, Model Number 01EVE500 There is a potential for the unit to catch fire due to one of the screen retaining screws being i... Class I O-Two Medical Technologies, Inc.
Feb 8, 2019 Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardio... Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled inc... Class I Maquet Cardiovascular Us Sales, Llc
Feb 1, 2019 LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(... Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after ... Class I Physio-Control Inc
Feb 1, 2019 Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. ... The products were manufactured without a back bevel on the needle tip. This could cause damage to... Class I Cook Inc.
Feb 1, 2019 LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor... Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after ... Class I Physio-Control Inc
Jan 17, 2019 Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): ... A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamb... A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1... A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD):... A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...

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.