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MEDICAL DEVICE RECALLCRITICAL
Erbe Flexible Cryoprobe
Erbe recalls Flexible Cryoprobes (REF 20402-401) due to rupture/burst risk.
What to do
Stop using the affected cryoprobes immediately. Contact Erbe USA Inc for instructions on returning the product and obtaining a replacement.
Why it was recalled
Erbe USA Inc is recalling Flexible Cryoprobes (REF 20402-401) because the probes may rupture or burst during activation, posing a risk of injury to patients.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | UPC | Recall # |
|---|---|---|
| Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical use | 04050147021785 | Z-1566-2026 |
| Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use | 04050147021846 | Z-1568-2026 |
| Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use | 04050147021822 | Z-1567-2026 |
| 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.
Official source
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Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification