Blanketrol III — Class II medical device recall Z-2970-2026
Ongoing recall by Gentherm Medical, LLC, reported 2026-08-26, distributed nationwide. Overheating of the 115V CPU board may cause the device to shut down.
| Recall number | Z-2970-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gentherm Medical, LLC, Blue Ash, OH, United States |
| Recall initiated | 2026-07-13 |
| Classified | 2026-08-14 |
| Reported by FDA | 2026-08-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, BS, CA, CL, CO, CR, GT, MX, PA, SA, SV, TH, TT, TW |
| Quantity | 9,714 units |
| Reason classes | device malfunction |
| Serial numbers | 131-2-00580 |
| Model numbers | 233 |
Product
Blanketrol III, Model 233; Thermal regulating system.
Reason for recall
Overheating of the 115V CPU board may cause the device to shut down.
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-2970-2026. 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.