ZOLL Circulation, Inc.

Complete recall history across all FDA and CPSC categories — 33 total recalls

ZOLL Circulation, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (33)

FDA medical device enforcement actions by ZOLL Circulation, Inc.

Date Product Reason Class
Mar 4, 2025 Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT P... AutoPulse NXT Resuscitation System may not provide adequate chest compression... Class I
Sep 22, 2022 AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100... Due to increase in Li-Ion Battery failures Class II
Aug 6, 2021 Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat... Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Cathete... Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 Zoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Cath... Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Cathe... Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Ki... Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start ... Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP K... Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP ... Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.) Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter ... Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Cat... Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Cat... Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular He... Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.) Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Cathe... Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ... Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit... Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter ... Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular ... Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular ... Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.) Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP... Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Cat... Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Cathe... Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat... Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat... Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter ... Labeling update concerning potential leaks from the catheter or the start-up... Class II
Aug 6, 2021 ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Cathe... Labeling update concerning potential leaks from the catheter or the start-up... Class II
Apr 1, 2014 7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen de... After aquisition of assets of CoAxia, Zoll discovered that one lot of NeuroFl... Class II
Jul 16, 2013 Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (... Typographical error in the Japanese legal label of the AutoPulse Resuscitatio... Class III
Aug 8, 2012 AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyva... Complaints associated with an unexpected stop in AutoPulse compressions. Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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