Stih: PRISMAFLO II S Blood Return Warmer May Cause Low-Level Skin Burns

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Recalling firmStihler Electronic GmbhJulius-Holder-Str. 36, N/A · Stuttgart, N/A N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Stihler is recalling PRISMAFLO II S blood return warmers (Product Code PF2-WP31) because they can cause low-level skin burns from hotspots. This affects units with serial number E22368.

Why it’s dangerous

The warmer can develop hotspots on the heating profile, which may cause low-level skin burns. This happens due to improper temperature regulation in the device.

Who’s affected

Users of the PRISMAFLO II S blood return warmer for Prismaflex systems are affected. People with the specific serial number E22368 are most at risk.

How to tell if you have this one

Check for the Product Code PF2-WP31 on the warmer. Affected units have the serial number E22368.

Brand
Stihler
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Code
Look for Product Code PF2-WP31 on the warmer.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall states that the warmer can cause low-level skin burns, so it is not safe to use without addressing the issue.

What should I do if I have this product?

The recall does not specify a remedy, so you should check with Stihler Electronic Gmbh for further instructions.

How can I tell if my warmer is affected?

Affected units have Product Code PF2-WP31 and serial number E22368.

Take action

Contact Stihler

We’ve drafted a message you can send Stihler to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0760-2019 — Stihler Stihler

Hello,

I own a Stihler that is covered by recall Z-0760-2019 from Stihler.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0760-2019 (September 6, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0760-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Stihler Electronic Gmbh recalls Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP31 Product Usage: The PRISMAFLO

Lower-risk recall