Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Infant Heel Warmer and Infant Gel Warmer Recalled by CooperSurgical, Inc. Due to Product marketed without a 510(k)
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact CooperSurgical, Inc. directly.
Affected Products
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
Quantity: 6,344,700
Why Was This Recalled?
Product marketed without a 510(k)
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About CooperSurgical, Inc.
CooperSurgical, Inc. has 83 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report