Pack, Hot Or Cold, Reusable
Physical Medicine · 21 CFR 890.5700
Recent MDR events
323 adverse event reports on file
- MedlineJul 31, 2026MalfunctionMedline Industries, Lp1417592-2026-12267
- MEDLINEJul 30, 2026MalfunctionMedline Industries, Lp1417592-2026-11963
- MedlineJul 29, 2026MalfunctionMedline Industries, Lp1417592-2026-11661
- MedlineJul 29, 2026MalfunctionMedline Industries, Lp1417592-2026-11666
- MedlineJul 27, 2026MalfunctionMedline Industries, Lp1417592-2026-07820
- StriveJul 27, 2026InjuryApothecary Products Llc2183416-2026-00003
- REUSABLE,HOT/COLD,SM,WALMARTJul 22, 2026MalfunctionMedline Industries, Lp1417592-2026-07543
- MEDLINEJul 22, 2026MalfunctionMedline Industries, Lp1417592-2026-07566
- MEDLINEJul 22, 2026MalfunctionMedline Industries, Lp1417592-2026-07809
- MEDLINEJul 21, 2026MalfunctionMedline Industries, Lp1417592-2026-07214
Event type breakdown
Recalls
12 recall events for this product code
- DJO, LLCOpen, ClassifiedNov 26, 2025
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.
Z-0722-2026 · View FDA record ↗ - Cardinal Health 200, LLCOpen, ClassifiedNov 7, 2022
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 .
Z-0185-2023 · View FDA record ↗ - Cardinal Health 200, LLCOpen, ClassifiedNov 7, 2022
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 .
Z-0186-2023 · View FDA record ↗ - Cardinal Health 200, LLCOpen, ClassifiedNov 7, 2022
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 .
Z-0187-2023 · View FDA record ↗ - Cardinal Health 200, LLCOpen, ClassifiedNov 7, 2022
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 .
Z-0188-2023 · View FDA record ↗ - Cardinal Health 200, LLCOpen, ClassifiedNov 7, 2022
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 .
Z-0189-2023 · View FDA record ↗ - Cardinal Health 200, LLCOpen, ClassifiedNov 7, 2022
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 .
Z-0190-2023 · View FDA record ↗ - Cardinal Health 200, LLCOpen, ClassifiedNov 7, 2022
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 .
Z-0191-2023 · View FDA record ↗ - Cardinal Health 200, LLCOpen, ClassifiedNov 7, 2022
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 .
Z-0192-2023 · View FDA record ↗ - Lansinoh Laboratories IncTerminatedFeb 4, 2013
THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box.
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.
Z-0784-2013 · View FDA record ↗
Registered firms
485 firms currently registered for this product code
Wmi Enterprises, Llc
Indianapolis, IN, US
Pacific Shore Holdings, Inc.
Canoga Park, CA, US
Daiso Industries Co., Ltd.
Higashihiroshima, JP
North Coast Medical, Inc.
Morgan Hill, CA, US
Hangzhou Aosi Healthcare Co., Ltd.
HANGZHOU Zhejiang, CN
Ningbo Landing Technology Company Co., Ltd.
Ningbo Zhejiang, CN
Swissco L.l.c.
Manhattan, NY, US
American Hospital Supply
Santa Monica, CA, US
Medtech Products, Inc.
Tarrytown, NY, US
Prokold Corp
Norman, OK, US
Bandicool
Middle Park Victoria, AU
Medline Industries, Lp - Northfield
Northfield, IL, US
Changzhou Recoo Healthcare Co., Ltd.
Changzhou Jiangsu, CN
Ningbo First Import & Export Co., Ltd.
NINGBO Zhejiang, CN
Braceability, Inc.
Cedar Falls, IA, US
Prollenium Medical Technologies Inc.
Richmond Hill Ontario, CA
Ossur Iceland Ehf.
REYKJAVIK, IS
R&r Medical Corporation Ltd.
Sanchong District New Taipei, TW
Aso Llc
SARASOTA, FL, US
Pantymed S.a.
BUENOS AIRES Buenos Aires, Ciudad Autonoma de, AR
Elevate Brands Opco Llc
New York, NY, US
Mainline Medical Dental Supply
North York Ontario, CA
Tien Jiang Enterprise Co., Ltd.
TAINAN CITY, TW
Yangzhou Juli Sports Articles Co.,ltd.
YangZhou Jiangsu, CN
Shanghai Gk Industrial Co.,ltd.
Shanghai, CN
510(k) clearances
27 clearances for this product code
- Friendmed ProductsApr 14, 1993
K923627 · COLD PACK
- Ten Comfort Corp.Feb 12, 1993
K915876 · HOTPAD
- Thermionics Corp.Jul 13, 1992
K921446 · HOT OR COLD PACK (THERMIPAQ)
- Micro Surgical Instruments Corp.Jan 22, 1991
K905207 · MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS
- Ferguson MedicalNov 30, 1988
K882413 · SUBOCCIPITAL ICE PILLOW
- K & L Ent.Oct 23, 1986
K863654 · RE-HEATER, HOT PACK
- Universal Medical Instrument Corp.Aug 31, 1983
K832193 · NICE PACK
- Dr. Micheal A. SabiaJul 7, 1983
K831899 · ENSWELL