RecallRadar

FDA Device recall Z-1301-2015

NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Warmer

On 2015-03-25 the FDA classified a Class II recall of NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Warmer by Coopersurgical, citing products without expiration date have the remote potential for minor burn.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1301-2015
ClassificationClass II
Statusterminated
Initiated2015-01-26
Published2015-03-25
Last updated2026-09-13 11:53 UTC
CompanyCoopersurgical
DistributionUS

Product

NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Warmer. Item #V6393 Single Use and Disposable To provide gentle heat to increase blood flow and enhance infant blood sample collection

Reason

Products without expiration date have the remote potential for minor burn

Identifiers

code_infoProducts without an expiration date and lot number

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1301-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.