Z-1567-2026Class I

Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use

Name: Z-1567-2026 Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. 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 1.7mm, L1.15mm) REF: 20402-410. 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-1567-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-02-12
Posted: 2026-03-20
Recalling firm: Erbe USA Inc
Product: Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. 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: 8,284 units
Distribution: US Nationwide distribution, including Puerto Rico.
Product codes and lots: UDI: 04050147021822/Expanded Lots: WO472495 WO472496 WO472497 WO472612 WO472613 WO472614 WO473666 WO473667 WO473668 WO473669 WO473670 WO473791 WO476977 WO476978 WO476979 WO476980 WO477011 WO477012 WO477031 WO477511 WO477512 WO477661 WO477662 WO477663 WO477664 WO478276 WO478277 WO478278 WO478279 WO478313 WO478845 WO478846 WO479954 WO479955 WO479956 WO480079; Initial Lots: WO459860 WO462187 WO462322 WO462390 WO462391 WO462392 WO462393 WO462396 WO462677 WO462678 WO463323 WO463324 WO463325 WO463326 WO463386 WO463387 WO464280 WO464281 WO464282 WO464283 WO464284 WO465059 WO465060 WO465061 WO465062 WO467876 WO467877 WO467878 WO467879 WO468225 WO468226 WO468227 WO468642 WO468643 WO468644 WO468645 WO468647 WO468671 WO468672 WO468673 WO468674 WO469361 WO469362 WO469363 W2459858 W2459958 W2462283 W2463593 W2465596 W2465623 W2465693 W2465768 W2468859 W2470050 W2470051 W2470052 W4465597

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1567-2026
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)