San Jose, CA, United States
ZOLL Circulation, Inc. recalls
3 recalls recorded since 2018, most recently on 4 March 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 4 March 2025
- Reason
- AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.
- Distribution
- US: AL, CA, CT, FL, IL, KS, LA, MN, MO, MT, NC, ND, NM, NY, OH, OK< PA, TX, WI OUS: Canada, Hong Kong,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1533-2025
- Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software Version: Version 2.0.1 Product Description: The AutoPulse R
Ongoing Class II Medical devices
- Recall started
- 22 September 2022
- Reason
- Due to increase in Li-Ion Battery failures
- Distribution
- U.S.: AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, RN, TX, UT, VA, VT, Virgin Islands, WA, WI, WV and WY. O.U.S.: United Arab Emirates, Austria, Australia, Azerbaijan, Brazil, Bel
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0118-2023
- AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR
Terminated Class II Medical devices
- Recall started
- 6 August 2021
- Terminated
- 18 October 2024
- Reason
- Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV and the countries Australia, CANADA, CHINA, GERMANY, HUNGARY, PORTUGAL, SINGAPORE, T
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0043-2022, Z-0046-2022, Z-0057-2022, Z-0056-2022, Z-0052-2022, Z-0045-2022, Z-0065-2022, Z-0060-2022, Z-0040-2022, Z-0054-2022, Z-0050-2022, Z-0064-2022 and 16 more
- 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
- 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
- Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Heparin, Sterile EO, Rx Only, UDI: (01)00849111075107
- Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075077
- Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), Heparin COATED, Sterile EO, Rx Only, UDI: (01)00849111075541
- ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens) HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075213
- Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
- Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.)
- and 20 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.