Flexible Cryoprobe recall (Erbe USA Inc)
Medical deviceClass IOngoing
Summary: Erbe USA Inc is recalling Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use. Reason: Probes may rupture/burst during activation.
What is being recalled
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Why
Probes may rupture/burst during activation
How serious is it
Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.
Where it was sold
US Nationwide distribution, including Puerto Rico. (states named: Puerto Rico)
How to tell if yours is affected
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
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1568-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class I |
| Status | Ongoing |
| Recall started | February 12, 2026 |
| Reported | April 1, 2026 |
| Company | Erbe USA Inc |
| Company location | Marietta, GA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 3603 units |
More recalls from Erbe USA Inc · all medical device recalls · recalls from February 2026