Pack, Hot Or Cold, Disposable

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2024-09-19Open, ClassifiedProcess control

  HAWK Warming Grid, Item Number: 59-300

  Incorrect expiration date.

• 2024-09-19Open, ClassifiedProcess control

  HAWK Advanced Hypothermia Management Set, Item Number: 59-320

  Incorrect expiration date.

• 2024-09-19Open, ClassifiedProcess control

  Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-300 HAWK Warming Grid, 2. Item Number: 59-320 HAWK Advanced Hypothermia Management Set. Convenience kits labeled as follows: Combat Life Saver - Intermediate (Product Number: 83-323-CB) contains 59-300 / 1 Each; Medic Enhancement Resupply (Product Number: 82-504-05) contains 59-300 / 1 Each; Combat Life Saver - Advanced (Product Number: 83-325-CB) contains 59-300 / 1 Each; Cold Weather (Product Number: 82-505) contains 59-300 / 1 Each; HAWK w/ Carrier Set, Multicam, Stocked (Product Number: 83-315-01-MC) contains 59-300 / 1 Each; Mojo Combat Life Saver - Intermediate - Multicam (Product Number: 83-323-MC); Combat Life Saver - Intermediate - Multicam (Product Number: 83-323-MC); Mojo Combat Life Saver - Advanced - Multicam (Product Number: 83-325-MC); DIRECT ACTION BAG, FOLIAGE GREEN, ADVANCED, STOCKED (Product Number: 84-497-FG).

  Incorrect expiration date.

• 2022-01-19Open, ClassifiedNo Marketing Application

  Infant Heel Warmers w/strap, Reference # 989805603201 1223

  After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

• 2022-01-19Open, ClassifiedNo Marketing Application

  Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T

  After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

• 2022-01-19Open, ClassifiedNo Marketing Application

  Medichoice Infant Heel Warmer, Reference # 989805643721 1079906

  After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

• 2022-01-18Open, ClassifiedNo Marketing Application

  Infa-Therm Transport Mattress, Reference Number 989805616831 1015

  After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

• 2016-04-04TerminatedLabeling design

  evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur

  eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, nor any warning that product used beyond its expected shelf life may warm to temperature above its specification.

• 2016-04-04TerminatedLabeling design

  eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur

  eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, nor any warning that product used beyond its expected shelf life may warm to temperature above its specification.

• 2015-12-24TerminatedLabeling design

  Cardinal Health Tiny Toes; 11470-010T Infant heel warmer

  Heel warmers may cause first and second degree burns.