Erbe flexible cryoprobe 20402-410 recalled as Class I over rupture
Erbe USA is recalling the Flexible Cryoprobe REF 20402-410 because the probes may rupture or burst during activation. The FDA has classified this recall as Class I.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The rubric states an FDA Class I recall is never scored below 4, and this record carries a Class I classification with no reported deaths in the source.
Plain-English summary
Erbe USA Inc is recalling the Flexible Cryoprobe (OD 1.7 mm, L1.15 mm), REF 20402-410, for surgical use. About 8,284 units were distributed nationwide in the United States including Puerto Rico.
The probes may rupture or burst during activation. The FDA has classified this recall as Class I, its most serious category.
Affected product carries UDI 04050147021822, across expanded lots beginning WO472495 and initial lots beginning WO459860.
Facilities can identify affected probes by the REF, UDI and lot numbers above, and may contact Erbe USA Inc for further information.
The recalled product
- Product
- Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
- Manufacturer
- Erbe USA Inc
- Category
- Medical Device — Cryosurgery
- Affected units
- 8,284
Distribution
Part of a larger recall action
This product is one of 3 recalled by Erbe USA Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Erbe USA Inc
See all →- SevereErbe ERBECRYO 2 Cryosurgical Unit Recalled Due to Rupture Risk
FDA (Devices) · 2026-08-19
- SevereErbe flexible cryoprobe 20402-411 recalled as Class I over rupture
FDA (Devices) · 2026-04-01
- SevereErbe flexible cryoprobe 20402-401 recalled as Class I over rupture
FDA (Devices) · 2026-04-01
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