FDA DevicesClass I
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 2040...
Published: April 1, 2026Recall ID: Z-1566-2026Category: devicesCountry: US
Reason for Recall / Hazard
Probes may rupture/burst during activation
Product Description & Identification
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
Affected Products
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
Additional Source Details
| Field | Value |
|---|---|
| City | Marietta |
| State | GA |
| Event id | 98429 |
| Address 1 | 2225 Northwest Pkwy SE |
| Code info | UDI: 04050147021785/ Expanded Lots: WO471345 WO471346 WO471347 WO471348 WO471349 WO472537 WO472538 WO472539 WO472540 WO472594 WO472595 WO472596 WO472597 WO472598 WO472599 WO472600 WO472601 WO472602 WO472603 WO472617 WO472618 WO472619 WO472620 WO472621 WO472622 WO472623 WO472624 WO472625 WO472626 WO472627 WO472628 WO472629 WO472630 WO472631 WO472632 WO472633 WO472634 WO472635 WO472636 WO472642 WO472643 WO472644 WO472647 WO472648 WO472649 WO473613 WO473614 WO473615 WO473616 WO473617 WO473618 WO473619 WO473646 WO473647 WO473648 WO473649 WO473650 WO473651 WO474289 WO474290 WO474291 WO474292 WO474580 WO474581 WO474582 WO474583 WO474584 WO474585 WO474586 WO474587 WO474588 WO475359 WO475360 WO475361 WO475362 WO475363 WO475364 WO475368 WO475369 WO475370 WO475371 WO475372 WO475373 WO475374 WO475375 WO475376 WO475377 WO475378 WO475382 WO475383 WO475384 WO475385 WO475386 WO476017 WO476018 WO476019 WO476020 WO476021 WO476226 WO476227 WO476228 WO476229 WO476230 WO476231 WO476232 WO476233 WO476234 W... [TRUNCATED] |
| Postal code | 30067-8764 |
| Report date | 20260401 |
| Product type | Devices |
| Product quantity | 64216 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.