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Browse Device Recalls

3,454 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,454 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 3,454 FDA device recalls — Class I.

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DateProductReasonClassFirm
May 14, 2019 IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.... Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during c... Class I Edwards Lifesciences, LLC
May 10, 2019 Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets. BD code ... This recall is a sub recall to BD s recent Class I recall for the Alaris Pump Infusion Set due to... Class I Medline Industries Inc
May 10, 2019 Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated L... Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonata... Class I Teleflex Medical
May 6, 2019 Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294,... An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment... Class I Becton Dickinson & Company
May 3, 2019 Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warm... The Vyaire enFlow disposable cartridge was recalled due to the potential for unsafe aluminum leve... Class I Medline Industries Inc
May 1, 2019 B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog ... Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint ... Class I B. Braun Medical, Inc.
Apr 26, 2019 SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, S... There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting ... Class I Terumo Medical Corporation
Apr 26, 2019 Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSO... There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting ... Class I Terumo Medical Corporation
Apr 26, 2019 SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR... There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting ... Class I Terumo Medical Corporation
Apr 11, 2019 Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon E... The staplers may have an insufficient firing stroke to break the washer and completely form staples. Class I Ethicon Endo-Surgery Inc
Apr 11, 2019 Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon E... The staplers may have an insufficient firing stroke to break the washer and completely form staples. Class I Ethicon Endo-Surgery Inc
Apr 11, 2019 Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The E... The staplers may have an insufficient firing stroke to break the washer and completely form staples. Class I Ethicon Endo-Surgery Inc
Apr 11, 2019 Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The E... The staplers may have an insufficient firing stroke to break the washer and completely form staples. Class I Ethicon Endo-Surgery Inc
Apr 11, 2019 Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon E... The staplers may have an insufficient firing stroke to break the washer and completely form staples. Class I Ethicon Endo-Surgery Inc
Apr 11, 2019 Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon End... The staplers may have an insufficient firing stroke to break the washer and completely form staples. Class I Ethicon Endo-Surgery Inc
Apr 11, 2019 Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The E... The staplers may have an insufficient firing stroke to break the washer and completely form staples. Class I Ethicon Endo-Surgery Inc
Apr 11, 2019 Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon E... The staplers may have an insufficient firing stroke to break the washer and completely form staples. Class I Ethicon Endo-Surgery Inc
Apr 11, 2019 Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A The Ethicon End... The staplers may have an insufficient firing stroke to break the washer and completely form staples. Class I Ethicon Endo-Surgery Inc
Apr 11, 2019 Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon End... The staplers may have an insufficient firing stroke to break the washer and completely form staples. Class I Ethicon Endo-Surgery Inc
Apr 11, 2019 Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The E... The staplers may have an insufficient firing stroke to break the washer and completely form staples. Class I Ethicon Endo-Surgery Inc
Apr 11, 2019 Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon End... The staplers may have an insufficient firing stroke to break the washer and completely form staples. Class I Ethicon Endo-Surgery Inc
Apr 8, 2019 MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System ... The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount sto... Class I Integra LifeSciences Corp.
Apr 8, 2019 LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS902... The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount sto... Class I Integra LifeSciences Corp.
Apr 8, 2019 MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniT... The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount sto... Class I Integra LifeSciences Corp.
Mar 28, 2019 Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx... Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of ballo... Class I Edwards Lifesciences, LLC
Mar 28, 2019 Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, ... Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of ballo... Class I Edwards Lifesciences, LLC
Mar 25, 2019 HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTO... New software version for affected ventilators reduces the probability of the ventilator entering ... Class I Hamilton Medical AG
Mar 21, 2019 EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usag... Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress i... Class I Edwards Lifesciences, LLC
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.0, .070", REF SA6AL10. 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 JL3.0 SH, .070", REF SA6JL30SH. 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, 3DRC 100CM .070", REF SA63DRC. 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 ERAD RIGHT SHORT TIP, .070", REF SA6ERA... 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 SL4.5, .070", REF SA6SL45. 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 AL2.0, .070", REF SA6AL20. 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 90CM, .070", REF SA6LCBD. 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 110CM AL20, REF SA6AL20A. 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 SL5.0, .070", REF SA6SL50. 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 SH, .070", REF SA6CHAMP20SH. ... 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, .070", REF SA6AL75. 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 EBU4.0 SH, .070", REF SA6EBU40SH. 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 LARA, .070", REF SA6LARA. 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 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, 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 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 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 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, 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 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 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 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

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.