CLASS II Device recall · Reported 16 Jan 2013 · FDA Enforcement Report

AutoPulse Resuscitation System recalled by Zoll Circulation

Zoll Circulation is recalling AutoPulse Resuscitation System. The recall was initiated on 8 Aug 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesall

Quantity recalled3881 in US, 1846 ROW.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0658-2013
FDA event ID: 62950
Recalling firm: Zoll Circulation, Sunnyvale, CA
Classification: Class II
Status: Terminated
Recall initiated: 8 Aug 2012
FDA classified: 9 Jan 2013
Reported: 16 Jan 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

8 Aug 2012	Recall initiated by company
9 Jan 2013	Classified by FDA	+154 days
16 Jan 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Complaints associated with an unexpected stop in AutoPulse compressions.

Product as listed by the FDA

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 spontaneous breathing and pulse.

Where it was distributed

Worldwide distribution.

Questions about this recall

Is AutoPulse Resuscitation System recalled?

Yes. Zoll Circulation recalled AutoPulse Resuscitation System on 8 Aug 2012. The recall is Class II and its status is Terminated. Recall number Z-0658-2013.

Why was it recalled?

Complaints associated with an unexpected stop in AutoPulse compressions.

Which lots are affected?

all

Where was it sold?

Worldwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Zoll Circulation

All 33

Reported	Class	Recall	Company	Reason	Where
23 Apr 2025Device	CLASS I	AutoPulse NXT Resuscitation System AutoPulse NXT Platform recalled	ZOLL Circulation	Device Malfunction	18 states
2 Nov 2022Device	CLASS II	AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System recalled	ZOLL Circulation	Device Malfunction	47 states
13 Oct 2021Device	CLASS II	Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat recalled	ZOLL Circulation	Sterility	Nationwide
13 Oct 2021Device	CLASS II	Zoll REF: 8700-0783-01 (IC-4593) recalled by ZOLL Circulation	ZOLL Circulation	Sterility	Nationwide
13 Oct 2021Device	CLASS II	Zoll REF: 8700-0783-14 (IC-4593CO), Quattro Intravascular Heat recalled	ZOLL Circulation	Sterility	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide