RecallRadar

FDA Device recall Z-1568-2026

Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411

On 2026-04-01 the FDA classified a Class I recall of Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411 by Erbe Usa, citing probes may rupture/burst during activation.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1568-2026
ClassificationClass I
Statusongoing
Initiated2026-02-12
Published2026-04-01
Last updated2026-09-13 11:58 UTC
CompanyErbe Usa
DistributionUS

Product

Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use

Reason

Probes may rupture/burst during activation

Identifiers

code_info
UDI: 04050147021846/ Expanded Lots:WO472498 WO472499 WO472615 WO472616 WO473794 WO473795 WO474908 WO474909 WO474910 WO4…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1568-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.