Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1495-2019 — ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 - Product Usage: ThermaCare(R) HeatWraps are indicated in adults to provide heat therapy for the temporary relief of minor muscular and joint pains associated with overexertion, strains, sprains, and arthritis and menstrual pain. The

U.S. FDA — Device Enforcement · United States · 2019-04-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1495-2019
Date of alert
2019-04-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
PF Consumer Healthcare 1 LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
305733010037
Reported risk: There is the potential that a HeatWrap could include cells that have a higher cell temperature than specified in lot S97473. The use of heat cell wrap with increased temperatures poses a potential risk of skin injuries such as burns/blisters and/or skin irritation on the wrap-applied area.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.