CLASS II ONGOING Device recall · Reported 3 Dec 2025 · FDA Enforcement Report
Cold Form Wrap: Back recalled by DJO
DJO is recalling Cold Form Wrap: Back, distributed nationwide in the US. The recall was initiated on 25 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0722-2026
- FDA event ID
- 97610
- Recalling firm
- DJO, Carlsbad, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Sep 2025
- FDA classified
- 26 Nov 2025
- Reported
- 3 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 25 Sep 2025 | Recall initiated by company | |
| 26 Nov 2025 | Classified by FDA | +62 days |
| 3 Dec 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
Where it was distributed
US Nationwide distribution in the states of WI, TN, TX, MD, GA, UT, WA, MI, NC, NE, CA, MA, CO, SC, OH, IN, MN, NM, PA, NY, IL, FL, NJ, VA, AZ, VT, CT, OK.
Nationwide ArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIllinoisIndianaMassachusettsMarylandMichiganMinnesotaNorth CarolinaNebraskaNew JerseyNew MexicoNew YorkOhioOklahomaPennsylvania
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
REF/UDI-DI/Lot: DP163CT02/00888912164382/190523, 171221. DP163CT03-BLK-L,XL/00888912164481/150221, 180821
Where was it sold?
US Nationwide distribution in the states of WI, TN, TX, MD, GA, UT, WA, MI, NC, NE, CA, MA, CO, SC, OH, IN, MN, NM, PA, NY, IL, FL, NJ, VA, AZ, VT, CT, OK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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