Stih: PRISMAFLO II S Blood Return Warmer Risk of 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 that may cause low-level skin burns due to hotspots. This affects units with serial numbers E22000 to E23999.

Why it’s dangerous

The heating profile may develop hotspots that cause low-level skin burns. This occurs because the warmer is designed to heat blood flow but can overheat in specific conditions.

Who’s affected

Users of the PRISMAFLO II S blood return warmer for Prismaflex devices with serial numbers E22000 to E23999 are affected. People using this device for blood circulation therapy are most at risk.

How to tell if you have this one

Check for the product code PF2-WP33 on the device. Affected units have serial numbers from E22000 to E23999. The warmer is used for Prismaflex blood return systems.

Brand
Stihler
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Number
Look for serial numbers E22000 to E23999 on the device.

✎ GovInfoNow

Questions people ask

What is the product code for the recalled warmer?

The product code is PF2-WP33.

What does the recall say about the hazard?

The recall states that hotspots may cause low-level skin burns.

How can I tell if my warmer is affected?

Check for serial numbers E22000 to E23999 on the device.

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-0759-2019 — Stihler Stihler

Hello,

I own a Stihler that is covered by recall Z-0759-2019 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-0759-2019 (September 6, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0759-2019 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-WP33 Product Usage: The PRISMAFLO

Lower-risk recall