Z-1568-2026Class I

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

Name: Z-1568-2026 Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Creator: Erbe USA Inc
Published: 2026-02-12
License: https://open.fda.gov/license/

Erbe USA Inc / initiated 2026-02-12 / Open, Classified / root cause: manufacturing process

FDA source

Erbe USA Inc began a recall of Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use on 2026-02-12. FDA classified it as Class I and gives the reason as "Probes may rupture/burst during activation". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1568-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-02-12
Posted: 2026-03-20
Recalling firm: Erbe USA Inc
Product: Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Product code: GEH Unit, Cryosurgical, Accessories
Reason for recall: Probes may rupture/burst during activation
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On May 5, 2026, ERBE USA issued a "Urgent Medical Device Recall Expansion notification via E-Mail. The expansion was issued due to new lot numbers that may cause the same failure mode. The original notification was issued on Feb. 12, 2026. ERBE asked consignees to take the following actions: 1. Discontinue use of the products with the affected lot numbers. 2. Examine your inventory, remove, and quarantine any identified devices with the affected lot numbers 3. Ensure all applicable personnel within the vicinity of device activation carefully read the content of this notification. If affected product has been transferred to a different location, please ensure that location and personnel receive a copy of this notification. 4. Please contact Erbe at [email protected] or 678-483-8499, to obtain a Return Material Authorization number 5. Please complete the Response Form and return to Erbe 6. If you have further distributed this product, identify your locations, and forward this notification to them. 7. Erbe requests you to report any complaints, including any instances of ruptures/bursts, to our Technical Service Department at 770-955-4400. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program.
Quantity in commerce: 3603 units
Distribution: US Nationwide distribution, including Puerto Rico.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1568-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1566-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20
Z-1567-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20
Z-1568-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20

Product code GEH

K190651Class IIERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapterErbe Elektromedizin GmbH / cleared 2020-01-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)