CooperSurgical, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2147-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : CooperSurgical PN 20418 WARMGEL INFANT HEEL WARMER - PRISM BOX OF 100; PN 24401 LIQUID INFANT HEEL WARMER - PRISM BOX OF 100; and Fisher Brand. PN 24647 FISHERBRAND GEL INFANT - HEEL WARMER BOX OF 100; PN 24646 FISHERBRAND LIQUID INFANT - HEEL WARMER- 100 PER BOX

Product Classification:

Class II

Date Initiated: July 6, 2015

Date Posted: July 29, 2015

Recall Number: Z-2147-2015

Event ID: 71597

Reason for Recall:

Product marketed without a 510(k)

Status: Terminated

Product Quantity: 6,344,700

Code Information:

All lot numbers

Distribution Pattern:

Worldwide Distribution - Nationwide Distribution and to the countries of : AUSTRALIA, BERMUDA, ECUADOR , FRANCE, NEW ZEALAND, SAUDI ARABIA and UNITED KINGDOM.

Voluntary or Mandated:

Voluntary: Firm initiated