Hot and cold wraps recalled over microwave instructions causing burns
DJO is recalling 1,594 Cold Form Wraps because the instructions tell users to microwave the wrap for three minutes, which may cause leaks or second degree burns.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the printed heating instruction can produce temperatures capable of a second degree burn, and no injuries are reported.
Plain-English summary
The DJO Cold Form Wrap for the back (REF DP163CT03-BLK-L,XL) and shoulder (REF DP163CT02) is being recalled.
The Information for Use on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which DJO states may cause the wrap to leak or break at the seams and/or reach temperatures capable of causing a second degree burn.
The recall covers 1,594 units, including UDI-DI 00888912164382 for the shoulder wrap, across lots 190523, 171221, 150221 and 180821. The product was distributed nationwide in the United States. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Anyone holding an affected wrap should follow the firm's instructions rather than the microwave time printed on it.
The recalled product
- Product
- Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
- Manufacturer
- DJO, LLC
- Category
- Medical Device — Therapy wrap
- Affected units
- 1,594
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- REF/UDI-DI/Lot: DP163CT02/00888912164382/190523
- 171221. DP163CT03-BLK-L
- XL/00888912164481/150221
- 180821
Distribution
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