Manufacturer

ZOLL Circulation, Inc.

33 recalls in our database name ZOLL Circulation, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 33
Critical: 1
Severe: 0
Most recent: 2025-04-23

Of the 33 recalls from ZOLL Circulation, Inc. we have scored against our rubric, 1 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–33 of 33

ModerateFDA (Devices)·Z-0043-2022·2021-10-13
ZOLL SOLEX 7 Intravascular Catheter Kit Labeling Update for Potential Leaks
ZOLL Circulation, Inc. is updating labeling for SOLEX 7 intravascular heat exchange catheter kits to communicate about potential leaks from the catheter or start-up kit tubing. The update affects 5,345 kits with worldwide distribution.
Product
ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (00)849111075312
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0042-2022·2021-10-13
ZOLL Premium Access Kit SOLEX 7 Catheter Kit Labeling Update on Potential Leaks
ZOLL has issued a labeling update for its Premium Access Kit SOLEX 7 intravascular heat exchange catheter regarding potential leaks from the catheter or tubing. Approximately 5,524 kits were distributed worldwide.
Product
ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabilities (3 lumens), Use Jugular or Subclavian Vein Approach Only, 20 cm, Sterile EO, Rx Only, UDI:
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0063-2022·2021-10-13
Zoll Cool Line Catheter Kits Recalled Due to Potential Tubing Leaks
ZOLL Circulation recalls Cool Line (Heparin) IVTM catheter kits due to potential leaks in catheter or start-up kit tubing. The recall affects 144 bundles distributed worldwide.
Product
Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0046-2022·2021-10-13
ZOLL ICY Intravascular Catheter Kit: Labeling Update for Potential Leaks
ZOLL Circulation recalls 333 units of its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing. A labeling update addresses the leak risk affecting medical facilities worldwide.
Product
ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STERILE EO, Rx Only, UDI: (01)00849111075220
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0050-2022·2021-10-13
Zoll ICY Heat Exchange Catheter Kit Labeling Update Due to Potential Leaks
ZOLL Circulation is updating labeling for its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing. The recall affects 1,256 units distributed worldwide.
Product
Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075527
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0477-2015·2014-12-03
ZOLL Recalls NeuroFlo Catheter Due to Missing Regulatory Filing
ZOLL Circulation is recalling one lot of NeuroFlo Catheters because a required regulatory supplement was not filed after the company acquired the product's assets.
Product
7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysmal subarachnoid hemorrhage. The NeuroFlo Catheter is und
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-2090-2014·2014-07-30
Zoll Circulation Recalls AutoPulse Accessories Due to Japanese Label Typo
Zoll Circulation is recalling 161 NiMH batteries and 40 LifeBand packs distributed in Japan due to a typographical error on the Japanese legal label.
Product
Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest compression assembly that consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. The AutoPulse Battery is a removable c
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0658-2013·2013-01-16
Zoll AutoPulse Resuscitation System Recalled for Unexpected Compression Stops
Zoll Circulation is recalling AutoPulse Model 100 systems because they may stop compressions unexpectedly during use.
Product
AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spont
Category
Medical Device
Distribution
0 states