A warming pad — Class II medical device recall Z-1139-2019
Completed recall by Pintler Medical LLC, reported 2019-04-24, distributed in WI. Malfunction warming pad.
| Recall number | Z-1139-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pintler Medical LLC, Philipsburg, MT, United States |
| Recall initiated | 2018-04-20 |
| Classified | 2019-04-12 |
| Reported by FDA | 2019-04-24 |
| Distributed | WI |
| Quantity | 24 |
| Reason classes | device malfunction |
| Lot numbers | 27473, 27498, 27544, 27590, 27634 |
| Model numbers | PIN-BH85, PIN-LG78-OS, PIN-SKY67-OS |
Product
A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol
Reason for recall
Malfunction warming pad.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1139-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.