Heating Profile PRISMAFLO II blood return warmer for Prismaflex… — Class II medical device recall Z-0761-2019
Terminated recall by Stihler Electronic Gmbh, reported 2019-01-30, distributed nationwide. PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot
| Recall number | Z-0761-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stihler Electronic Gmbh, Stuttgart, N/A, Germany |
| Recall initiated | 2018-09-06 |
| Classified | 2019-01-23 |
| Reported by FDA | 2019-01-30 |
| Terminated | 2020-05-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH |
| Quantity | 247 units |
| Serial numbers | UH07154, UH07479 |
Product
Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product Code: PF2-WP2618 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
Reason for recall
PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn
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-0761-2019. 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.