Recall archive
5 recalls · page 1 of 1
Reported Apr 7, 2021
AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Oscor, Inc.
Matched: Brand — Potential for open seal on sterile product
FDA (openFDA device enforcement)
Reported Nov 14, 2018
TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Oscor, Inc.
Matched: Brand — During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and…
FDA (openFDA device enforcement)
Reported Jul 19, 2017
ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Oscor, Inc.
Matched: Brand · Reason for recall — The Reusable Oscor ATAR extension cables could separate from the connector during use.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 28, 2016
OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Oscor, Inc.
Matched: Brand · Product · Product details — Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
29 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 7, 2012
Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Oscor, Inc.
Matched: Brand · Reason for recall — Oscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C, TME64S-3, TME65S, and TME66S. The recall was…
FDA (openFDA device enforcement)
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