Pack, Hot Or Cold, Reusable
FDA adverse event reports and recall history for pack, hot or cold, reusable (product code IME), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 391
- Deaths
- 1
- Injuries
- 188
- Malfunctions
- 162
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2025-11-26Open, ClassifiedLabeling Change Control
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at the seams and/or reach temperatures capable of causing a second degree burn.
- 2022-11-07Open, ClassifiedPending
Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .
- 2022-11-07Open, ClassifiedPending
Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .
- 2022-11-07Open, ClassifiedPending
Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .
- 2022-11-07Open, ClassifiedPending
Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .
- 2022-11-07Open, ClassifiedPending
Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .
- 2022-11-07Open, ClassifiedPending
Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .
- 2022-11-07Open, ClassifiedPending
Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .
- 2022-11-07Open, ClassifiedPending
Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .
- 2013-02-04TerminatedError in labeling
THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump.
The Spanish translation on the Instructions for Use (IFU) insert and product package for hot and cold packs has incorrect heating instructions which would cause product to over heat.
Monitor pack, hot or cold, reusable automatically
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