FDAFebruary 12, 2026device
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Probes may rupture/burst during activation
What to do
FDA enforcement status: Ongoing
Brands named
erbe
UPCs
04050147021785
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for Olympus Scopes, REF: 20325-206; Hybrid CO2 Tubing/Cap Set for Pentax Scopes, REF: 20325-207; ERBEFLO...2026-03-31
- FDAERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-2222026-03-31
- FDAERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;2026-03-31
- FDAFlexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use2026-02-12
- FDAFlexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use2026-02-12
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