Recall archive / FDA device enforcement
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use — FDA record Z-1567-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 12, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
- Reason
- Probes may rupture/burst during activation
- Classification
- Class I
- Recalling firm
- Erbe USA Inc
- Quantity
- 8,284 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1567-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution, including Puerto Rico.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 1, 2026
- Recall initiation date
- Feb 12, 2026
- Center classification date
- Mar 20, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.