Erbe USA flexible cryoprobe recalled for possible burst risk
Erbe USA Inc is recalling specific lots of Flexible Cryoprobe devices used in surgery because the probes may rupture or burst when activated. This defect could affect patient safety during the procedure. No injuries have been reported to date.
From the FDA notice · Read the official notice ↗
What to do
- Immediately stop using affected Flexible Cryoprobe devices (REF 20402-411) with the listed lot numbers
- Check your facility's inventory against the lot numbers provided
- Contact your Erbe USA Inc representative or the FDA for instructions on device return or replacement
- Review patient records for devices from affected lots already used
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 3 products — see all of them.
Details
- Units affected
- 2408 units
- Illnesses reported
- None reported
- Manufactured in
- 2225 Northwest Pkwy SE, Marietta, GA, United States
- Classification
- Class I
- Recall number
- Z-1568-2026
In the FDA's words
- Description
- Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use Probes may rupture/burst during activation UDI: 04050147021846/ Lots: WO461840 WO461846 WO462097 W2462284 WO463327 WO463328 WO463388 W2463594 WO464285 WO464286 WO465063 WO465064 W4465351 W2465601 W2465689 W2465749 W2465769 WO467873 WO467874 WO467875 WO468648 WO468649 WO469364 W2459861 W2459862 W2459863 Distribution: US Nationwide distribution, including Puerto Rico. Affected quantity: 2408 units
- Hazard
- Probes may rupture/burst during activation
3 products in this recall
Erbe flexible cryoprobes recalled for probe rupture risk
Erbe is recalling three models of flexible cryoprobes used in surgery because the probes may rupture or burst during activation. The recall covers about 40,900 units sold nationwide, including Puerto Rico. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical useZ-1566-2026 · 33390 units
- Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical useZ-1567-2026 · 5154 units
- Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use (this page)Z-1568-2026 · 2408 units
More from Erbe
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ModerateFDAAug 19, 2026