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Erbe Flexible Cryoprobe
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MEDICAL DEVICE RECALLCRITICAL

Erbe Flexible Cryoprobe

Erbe USA recalls Flexible Cryoprobes because probes may rupture or burst during use.

What to do

Do not use the affected Flexible Cryoprobe devices. Contact Erbe USA for instructions on returning the devices and obtaining a replacement.

Recalled
Listed
Updated
Recall No.
Z-1566-2026
Agency
FDA
Firm
Erbe USA Inc
Recall ID
98429
Status
ONGOING

Why it was recalled

Erbe USA is recalling its Flexible Cryoprobe surgical devices because the probes may rupture or burst during activation, posing a risk of serious injury to patients. The affected devices are sterile, single-use surgical instruments used in medical procedures.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductRecall #UDI-DI
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical useZ-1566-202604050147021785
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical useZ-1568-202604050147021846
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical useZ-1567-202604050147021822
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other recent recalls from Erbe USA Inc

All recalls from Erbe USA Inc

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Editorial summary by Recall Canary · summary updated 2026-08-06 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification