Erbe USA Inc medical device recall: Flexible Cryoprobe
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 98429
- Recall initiated
- Feb 12, 2026
- Classified by FDA
- Mar 20, 2026
- Posted in Enforcement Report
- Apr 1, 2026
- Recalling firm
- Erbe USA Inc
- Firm location
- Marietta, GA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Products in this event
- 3
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Probes may rupture/burst during activation
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Feb 12, 2026. FDA classified it 36 days later, on Mar 20, 2026. This recall event covers 3 separate products, each with its own FDA recall number. Distribution reported by FDA: US Nationwide distribution, including Puerto Rico. Erbe USA Inc has 2 recalls in our records.
Recalled products (3)
Z-1566-2026 Class I Ongoing
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
Codes / lots: UDI: 04050147021785/ Expanded Lots: WO471345 WO471346 WO471347 WO471348 WO471349 WO472537 WO472538 WO472539 WO472540 WO472594 WO472595 WO472596 WO472597 WO472598 WO472599 WO472600 WO472601 WO472602 WO472603 WO472617 WO472618 WO472619 WO472620 WO472621 WO472622 WO472623 WO472624 WO472625 WO472626 WO472627 WO472628 WO472629 WO472630 WO472631 WO472632 WO472633 WO472634 WO472635 WO472636 WO472642 WO472643 WO472644 WO472647 WO472648 WO472649 WO473613 WO473614 WO473615 WO473616 WO473617 WO473618 WO473619 WO473646 WO473647 WO473648 WO473649 WO473650 WO473651 WO474289 WO474290 WO474291 WO474292 WO474580 WO474581 WO474582 WO474583 WO474584 WO474585 WO474586 WO474587 WO474588 WO475359 WO475360 WO475361 WO475362 WO475363 WO475364 WO475368 WO475369 WO475370 WO475371 WO475372 WO475373 WO475374 WO475375 WO475376 WO475377 WO475378 WO475382 WO475383 WO475384 WO475385 WO475386 WO476017 WO476018 WO476019…
Quantity: 64216 units
Z-1567-2026 Class I Ongoing
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
Codes / 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
Quantity: 8,284 units
Z-1568-2026 Class I Ongoing
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Codes / 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
Quantity: 3603 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 98429
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.