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Browse Device Recalls

35 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35 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 35 FDA device recalls.

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DateProductReasonClassFirm
Mar 10, 2021 AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: in... Potential for open seal on sterile product Class II Oscor, Inc.
Sep 26, 2018 TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straig... During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connecto... Class I Oscor, Inc.
Mar 31, 2017 ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ... The Reusable Oscor ATAR extension cables could separate from the connector during use. Class I Oscor, Inc.
Mar 31, 2017 ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Seri... The Reusable Oscor ATAR extension cables could separate from the connector during use. Class I Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM Catalog # AB081045 Is designed... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F C120¿ S61CM D66CM Catalog # AB081043 Is design... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM Catalog # AB081046 Is designed ... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218 Is des... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F C120¿ S79CM D84CM Catalog # AB081047 Is design... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F C70¿ S61CM D66CM Catalog # AB081041 Is designed... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F C120¿ S79CM D84CM Catalog # AB101078 Is desig... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM Catalog # AB101075 Is desig... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM D66CM Catalog # AB101072 Is designe... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Cata... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed ... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Cat... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Cata... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077 Is design... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM Catalog # AB081044 Is designed... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is de... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Cat... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 Is des... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F C90¿ S61CM D66CM Catalog # AB081042 Is designed... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatal... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM GLOBAL Cat... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F C70¿ S61CM D66CM Catalog # AB101073 Is design... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076 Is design... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is desi... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Ca... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 Is designe... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Cata... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Cat... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is des... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Jul 25, 2012 Myocardial Heart Wires Intended for temporary atrial and ventricular pacin... Oscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C... Class II Oscor, Inc.

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.