FDA DevicesClass I
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Published: April 1, 2026Recall ID: Z-1568-2026Category: devicesCountry: US
Reason for Recall / Hazard
Probes may rupture/burst during activation
Product Description & Identification
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Affected Products
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Additional Source Details
| Field | Value |
|---|---|
| City | Marietta |
| State | GA |
| Event id | 98429 |
| Address 1 | 2225 Northwest Pkwy SE |
| Code info | 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 |
| Postal code | 30067-8764 |
| Report date | 20260401 |
| Product type | Devices |
| Product quantity | 3603 units |
| Reason for recall | Probes may rupture/burst during activation |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260212 |
| Initial firm notification | |
| Center classification date | 20260320 |
Overview
- Recalling FirmErbe USA Inc
- StatusOngoing
- Risk LevelClass I
- DistributionUS Nationwide distribution, including Puerto Rico.