Summary
The FDA issued a Class I for Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use by Erbe USA Inc. Reason: Probes may rupture/burst during activation.
Details
Source
Device Recall
External ID
Z-1568-2026
Action Date
2026-04-01
Status
Ongoing
Category
device
Product Description
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Lot/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
Quantity Affected: 3603 units
Reason for Recall
Probes may rupture/burst during activation
Distribution
US Nationwide distribution, including Puerto Rico.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-12
Company
Marietta, GA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 161 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Erbe USA Inc has 4 FDA actions in our database, including 3 recalls and 1 clearance.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Erbe USA Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Erbe USA Inc have FDA actions?
Erbe USA Inc has 4 FDA actions in our database, including 3 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1568-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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