Class II — Stihler Electronic Gmbh
| Recalling firm | STIHLER ELECTRONIC GMBH |
|---|---|
| Registered facility | STIHLER ELECTRONIC GMBH (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 |
| 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. |
| Quantity | 247 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of CA and Foreign of: Switzerland |
| Initiated | 2018-09-06 |
| Classified | 2019-01-23 |
| Terminated | 2020-05-13 |
| Recall number | Z-0761-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Stihler Electronic Gmbh (Z-0761-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81755/
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