CLASS II Device recall · Reported 30 Jan 2019 · FDA Enforcement Report
Heating Profile Prismaflo II S blood return warmer recalled
Stihler Electronic is recalling Heating Profile Prismaflo II S blood return warmer for Prismaflex Product, distributed nationwide in the US. The recall was initiated on 6 Sep 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0759-2019
- FDA event ID
- 81755
- Recalling firm
- Stihler Electronic, Stuttgart, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Sep 2018
- FDA classified
- 23 Jan 2019
- Reported
- 30 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 6 Sep 2018 | Recall initiated by company | |
| 23 Jan 2019 | Classified by FDA | +139 days |
| 30 Jan 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
Where it was distributed
Worldwide Distribution - US Nationwide in the states of CA and Foreign of: Switzerland
Questions about this recall
Is Heating Profile Prismaflo II S blood return warmer for Prismaflex Product recalled?
Yes. Stihler Electronic recalled Heating Profile Prismaflo II S blood return warmer for Prismaflex Product on 6 Sep 2018. The recall is Class II and its status is Terminated. Recall number Z-0759-2019.
Why was it recalled?
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
Which lots are affected?
Serial Numbers: E22000 to E23999
Where was it sold?
Worldwide Distribution - US Nationwide in the states of CA and Foreign of: Switzerland
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Stihler Electronic
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Heating Profile Prismaflo II blood return warmer recalled | Stihler Electronic | Other | Nationwide |
| Device | CLASS II | Heating Profile Prismaflo II S blood return warmer recalled | Stihler Electronic | Other | Nationwide |
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