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Critical recall: Death or serious injury has been reported or is considered likely. Stop using this product now.

Erbe USA Inc 2026-04-01 Health critical FDA
Health · FDA · Recall #FDA-Z-1566-2026

Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401… Recall

Issued April 1, 2026 · Erbe USA Inc

In April 2026, Erbe USA Inc recalled the Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.

Compiled by Maya Ellison, RecallCheckr

What this means for you

Probes may rupture/burst during activation

What you should do

  1. 1 Stop using Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Erbe USA Inc to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Erbe USA Inc
Category
Health
Recall date
April 1, 2026
Units affected
Not reported
Sold at
US Nationwide distribution, including Puerto Rico.
Recall number
FDA-Z-1566-2026
Made in
United States
Issuing agency
FDA

In context

  • Erbe USA Inc has 1 recall in our database, including 1 rated Critical.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 356th Health recall we've logged in 2026.
Read the official FDA notice

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