CLASS I ONGOING Device recall · Reported 1 Apr 2026 · FDA Enforcement Report

Flexible Cryoprobe (OD, L1 recalled by Erbe USA

Erbe USA is recalling Flexible Cryoprobe (OD, L1, distributed nationwide in the US. The recall was initiated on 12 Feb 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI: 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

Quantity recalled3603 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1568-2026
FDA event ID: 98429
Recalling firm: Erbe USA, Marietta, GA
Classification: Class I
Status: Ongoing
Recall initiated: 12 Feb 2026
FDA classified: 20 Mar 2026
Reported: 1 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

12 Feb 2026	Recall initiated by company
20 Mar 2026	Classified by FDA	+36 days
1 Apr 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Probes may rupture/burst during activation

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution, including Puerto Rico.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Probes may rupture/burst during activation

Which lots are 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

Where was it sold?

US Nationwide distribution, including Puerto Rico.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 98429

This product is part of a recall event; the main page for the event is Flexible Cryoprobe (OD, L1 recalled by Erbe USA.

Reported	Class	Recall	Company	Reason	Where
1 Apr 2026	CLASS I	Flexible Cryoprobe (OD, L1 recalled by Erbe USA	Erbe USA	Other	Nationwide
1 Apr 2026	CLASS I	Flexible Cryoprobe (OD, L1 recalled by Erbe USA	Erbe USA	Other	Nationwide

More recalls from Erbe USA

All 4

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Device	CLASS II	Erbecryo 2 Cryosurgical Unit recalled	Erbe USA	Packaging Defects	Nationwide
1 Apr 2026Device	CLASS I	Flexible Cryoprobe (OD, L1 recalled by Erbe USA	Erbe USA	Other	Nationwide
1 Apr 2026Device	CLASS I	Flexible Cryoprobe (OD, L1 recalled by Erbe USA	Erbe USA	Other	Nationwide

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