FDA Medical devices recall ·
Flexible Cryoprobe (OD 2.4mm, L1.15mm) recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1568-2026
- Date
- (initiated February 12, 2026)
- Company / brand
- Erbe USA Inc
2225 Northwest Pkwy SE, Marietta, GA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 3603 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Why was it recalled?
Probes may rupture/burst during activation
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI: 04050147021846/ Expanded Lots:WO472498 WO472499 WO472615 WO472616 WO473794 WO473795 WO474908 WO474909 WO474910 WO475357 WO475358 WO477030 WO477513 WO477514 WO478643 WO478646 WO478647 WO478648 WO478843 WO478844;Initial 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.
States: Puerto Rico
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1568-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.