CLASS II Device recall · Reported 25 Mar 2015 · FDA Enforcement Report

Fisher Gel Infant Heel Gel Warmers recalled by CooperSurgical

CooperSurgical is recalling Fisher Gel Infant Heel Gel Warmers, distributed nationwide in the US. The recall was initiated on 26 Jan 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProducts without an expiration date and lot number

Quantity recalled8865584 units

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-1299-2015
FDA event ID: 70286
Recalling firm: CooperSurgical, Trumbull, CT
Classification: Class II
Status: Terminated
Recall initiated: 26 Jan 2015
FDA classified: 19 Mar 2015
Reported: 25 Mar 2015
Type: Voluntary: Firm initiated
Customers notified by: Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

26 Jan 2015	Recall initiated by company
19 Mar 2015	Classified by FDA	+52 days
25 Mar 2015	Published in enforcement report	+6 days

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

Reason for recall

Products without expiration date have the remote potential for minor burn

Product as listed by the FDA

Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Brand Liquid Infant Heel Warmer, Cat. No: 22-024646 To provide gentle heat to increase blood flow and enhance infant blood sample collection

Where it was distributed

Worldwide Distribution - USA (nationwide) and Internationally to AUSTRALIA, BAHRAIN, BERMUDA, CANADA, FRANCE, LATVIA, LIBYA, MEXICO, NEW ZEALAND, QATAR, SAUDI ARABIA, SINGAPORE, and UNITED KINGDOM.

Nationwide

Questions about this recall

Why was it recalled?

Products without expiration date have the remote potential for minor burn

Which lots are affected?

Products without an expiration date and lot number

Where was it sold?

Worldwide Distribution - USA (nationwide) and Internationally to AUSTRALIA, BAHRAIN, BERMUDA, CANADA, FRANCE, LATVIA, LIBYA, MEXICO, NEW ZEALAND, QATAR, SAUDI ARABIA, SINGAPORE, and UNITED KINGDOM.

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.

Other products in this recall event

3 other products · FDA event 70286

This product is part of a recall event; the main page for the event is MediChoice WarmGel Infant Heel Warmer recalled by CooperSurgical.

Reported	Class	Recall	Company	Reason	Where
25 Mar 2015	CLASS II	MediChoice WarmGel Infant Heel Warmer recalled by CooperSurgical	CooperSurgical	Other	Nationwide
25 Mar 2015	CLASS II	Infant Heel Gel Warmers recalled by CooperSurgical	CooperSurgical	Other	Nationwide
25 Mar 2015	CLASS II	NovaPlus Warm Gel Infant Heel Gel Warmer recalled by CooperSurgical	CooperSurgical	Other	Nationwide

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