ZOLL Circulation, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000008550 FEI 3003793491
- Devices
- 383
- Registrations
- EUDAMEDFDA
- FDA recalls
- 342 ongoing
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA FEI, FDA recalls
What ZOLL Circulation, Inc. makes
The company manufactures line-powered cardiac resuscitators, including systems with external compression bands for cardiopulmonary resuscitation, as well as intravascular catheters and pads for core temperature regulation during resuscitation. It also produces secondary batteries, noninvasive battery chargers, and starter kits for intravascular cooling systems.
These devices are classified under FDA’s Class I, II, and III categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
Catalogue
Search and filter all 383 devicesShowing 1-50 of 383
Company details
- EUDAMED SRN
- US-MF-000008550
- FDA FEI number
- 3003793491
- DUNS number
- 799455241
- EUDAMED status
- Active
- EUDAMED registered name
- ZOLL Circulation, Inc.
- EUDAMED abbreviated name
- ZOLL
- Registered address
- 2000, Ringwood Avenue, 95131, San Jose, United States
- dlam@zoll.com
- Phone
- 4085412140
- PRRC contact
- Doug Lam
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 13 Oct 2029
TÜV SÜD Product Service GmbH 0123 2 certificates
- G10 092356 0015 Active
Quality management system EU MDR
- Issued
- 14 Oct 2024
- Expires
- 13 Oct 2029
- G10 092356 0021 Active
Quality management system EU MDR
- Issued
- 14 Oct 2024
- Expires
- 13 Oct 2029
FDA recalls
FDA recall records list 34 recalls initiated by ZOLL Circulation, Inc., the earliest on 2008-01-28 and the most recent on 2025-03-04. By recorded status: 2 ongoing and 32 terminated. The reasons filed fall into these groups: labeling or instructions for use, electrical or power, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 28
- 2022 1
- 2023 0
- 2024 0
- 2025 1
- 2026 0
2025
- 4 Mar 2025 Z-1533-2025 Class I Ongoing AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.
2022
- 22 Sep 2022 Z-0118-2023 Class II Ongoing Due to increase in Li-Ion Battery failures
Full distribution text
- 22 Sep 2022 Z-0118-2023 Class II Ongoing Due to increase in Li-Ion Battery failures
2021
- 6 Aug 2021 Z-0039-2022 Class II Terminated Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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- 6 Aug 2021 Z-0040-2022 Class II Terminated Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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- 6 Aug 2021 Z-0041-2022 Class II Terminated Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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- 6 Aug 2021 Z-0042-2022 Class II Terminated Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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- 6 Aug 2021 Z-0043-2022 Class II Terminated Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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- 6 Aug 2021 Z-0044-2022 Class II Terminated Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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- 6 Aug 2021 Z-0045-2022 Class II Terminated Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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- 6 Aug 2021 Z-0046-2022 Class II Terminated Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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- 6 Aug 2021 Z-0039-2022 Class II Terminated Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Show the 25 most recent of 34 recalls
2021
- 6 Aug 2021 Z-0047-2022 Class II Terminated Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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- 6 Aug 2021 Z-0048-2022 Class II Terminated Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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- 6 Aug 2021 Z-0049-2022 Class II Terminated Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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- 6 Aug 2021 Z-0050-2022 Class II Terminated Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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- 6 Aug 2021 Z-0051-2022 Class II Terminated Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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- 6 Aug 2021 Z-0052-2022 Class II Terminated Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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- 6 Aug 2021 Z-0053-2022 Class II Terminated Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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- 6 Aug 2021 Z-0054-2022 Class II Terminated Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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- 6 Aug 2021 Z-0055-2022 Class II Terminated Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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- 6 Aug 2021 Z-0056-2022 Class II Terminated Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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- 6 Aug 2021 Z-0057-2022 Class II Terminated Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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- 6 Aug 2021 Z-0058-2022 Class II Terminated Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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- 6 Aug 2021 Z-0059-2022 Class II Terminated Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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- 6 Aug 2021 Z-0060-2022 Class II Terminated Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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- 6 Aug 2021 Z-0061-2022 Class II Terminated Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Full distribution text
- 6 Aug 2021 Z-0047-2022 Class II Terminated Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Frequently asked questions
How many devices does ZOLL Circulation, Inc. have in the registry?
The registry currently lists 383 devices for ZOLL Circulation, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ZOLL Circulation, Inc.'s devices?
Among its 50 most recently registered devices, ZOLL Circulation, Inc. has devices listed in EUDAMED (1 device) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ZOLL Circulation, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for ZOLL Circulation, Inc.'s devices are Class IIb, Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for ZOLL Circulation, Inc.?
FDA recall records list 34 recalls initiated by ZOLL Circulation, Inc., the most recent initiated on 4 Mar 2025. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for ZOLL Circulation, Inc.?
EUDAMED lists 2 certificates for ZOLL Circulation, Inc. (quality management system) under MDR. 2 are recorded with the status issued. The most recent was issued on 14 Oct 2024.
What are the newest devices from ZOLL Circulation, Inc. in the registry?
The most recently registered devices listed for ZOLL Circulation, Inc. include VitalTemp™ Universal Pad, 2PK, US, AutoPulse NXT Platform, Thermogard HQTM Console ThermogardHQ, Lang set A and AutoPulse®Resuscitation System 100.