Recall archive
6 recalls · page 1 of 1
Reported Apr 23, 2025
Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ZOLL Circulation, Inc.
Matched: Brand — AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.
FDA (openFDA device enforcement)
Reported Nov 2, 2022
AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ZOLL Circulation, Inc.
Matched: Brand — Due to increase in Li-Ion Battery failures
FDA (openFDA device enforcement)
Reported Oct 13, 2021
Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ZOLL Circulation, Inc.
Matched: Brand · Product · Product details — Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
27 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 3, 2014
7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ZOLL Circulation, Inc.
Matched: Brand · Reason for recall — After aquisition of assets of CoAxia, Zoll discovered that one lot of NeuroFlo Catheters was manufactured by another firm and an HDE supplement…
FDA (openFDA device enforcement)
Reported Jul 30, 2014
Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Zoll Circulation, Inc.
Matched: Brand · Product · Product details — Typographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. The label is specific to the Japanese version of the…
FDA (openFDA device enforcement)
Reported Jan 16, 2013
AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zoll Circulation, Inc.
Matched: Brand · Product · Product details — Complaints associated with an unexpected stop in AutoPulse compressions.
FDA (openFDA device enforcement)
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