CooperSurgical, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1298-2015)

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:

CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 To provide gentle heat to increase blood flow and enhance infant blood sample collection

Product Classification:

Class II

Date Initiated: January 26, 2015

Date Posted: March 25, 2015

Recall Number: Z-1298-2015

Event ID: 70286

Reason for Recall:

Products without expiration date have the remote potential for minor burn

Status: Terminated

Product Quantity: 20398889 units

Code Information:

Products without an expiration date and lot number

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated