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U.S. Department of Health and Human Services

Class 1 Device Recall Erbe Flexible Cryoprobe

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 Class 1 Device Recall Erbe Flexible Cryoprobesee related information
Date Initiated by FirmFebruary 12, 2026
Date PostedMarch 20, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1566-2026
Recall Event ID 98429
510(K)NumberK190651 
Product Classification Unit, cryosurgical, accessories - Product Code GEH
ProductFlexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
Code Information 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 WO476020 WO476021 WO476226 WO476227 WO476228 WO476229 WO476230 WO476231 WO476232 WO476233 WO476234 WO476235 WO476273 WO476274 WO476275 WO476690 WO476691 WO476692 WO476693 WO476694 WO476695 WO476696 WO476697 WO476698 WO477070 WO477071 WO477072 WO477073 WO477497 WO477498 WO477499 WO477500 WO477501 WO477502 WO477503 WO477504 WO477505 WO477506 WO477507 WO477508 WO477686 WO477687 WO477688 WO477689 WO477979 WO477980 WO477981 WO477982 WO477983 WO477984 WO477985 WO477986 WO477987 WO477988 WO477989 WO477990 WO478178 WO478179 WO478180 WO478181 WO478182 WO478183 WO478184 WO478185 WO478186 WO478187 WO478188 WO478952 WO478953 WO478954 WO478955 WO478957 Initial Lots: WO461310 WO461311 WO461312 WO461314 WO461315 WO461829 WO461831 WO461832 WO461833 WO461834 WO461835 WO461842 WO461843 WO461844 WO461847 WO461848 WO462117 WO462118 WO462119 WO462120 WO462121 WO462122 WO462123 WO462124 WO462125 WO462128 WO462129 WO462130 WO462373 WO462374 WO462375 WO462376 WO462377 WO462378 WO462379 WO462380 WO462387 WO462388 WO462389 WO462397 WO462825 WO462826 WO462827 WO462828 WO462829 WO462830 WO462831 WO462838 WO462839 WO462840 WO462841 WO462842 WO462843 WO462844 WO462845 WO462846 WO462847 WO462848 WO462849 WO463308 WO463309 WO463310 WO463311 WO463312 WO463313 WO463314 WO463316 WO463317 WO463390 WO463391 WO463392 WO463393 WO463394 WO463395 WO463396 WO463397 WO463398 WO463399 WO463400 WO463401 WO463402 WO463403 WO463404 WO463405 WO463406 WO463407 WO463408 WO463409 WO464270 WO464271 WO464272 WO464273 WO464274 WO464275 WO464276 WO464277 WO464278 WO464279 WO464699 WO464700 WO464701 WO464702 WO464703 WO464994 WO464995 WO464996 WO464997 WO465021 WO465022 WO465023 WO465024 WO465025 WO465026 WO465027 WO465050 WO465051 WO465052 WO465053 WO465054 WO465055 WO465056 WO465057 WO465066 WO465067 WO465068 WO465069 WO465243 WO465244 WO465245 WO465246 WO465247 WO465248 WO465249 WO465255 WO465256 WO465257 WO465258 WO465259 WO465260 WO465261 WO465262 WO465266 WO465267 WO465268 WO465269 WO467858 WO467859 WO467860 WO467861 WO467862 WO467863 WO467884 WO467885 WO467886 WO468210 WO468211 WO468212 WO468213 WO468214 WO468215 WO468216 WO468217 WO468218 WO468219 WO468220 WO468221 WO468230 WO468231 WO468232 WO468609 WO468610 WO468611 WO468612 WO468613 WO468614 WO468618 WO468619 WO468620 WO468621 WO468622 WO468623 WO468624 WO468625 WO468626 WO468627 WO468628 WO468629 WO468630 WO468631 WO468632 WO468634 WO468635 WO468636 WO468637 WO468638 WO468639 WO468640 WO468641 WO468654 WO468655 WO468656 WO468657 WO468658 WO468659 WO468660 WO468661 WO468662 WO468663 WO468664 WO468665 WO468666 WO468669 WO468670 WO469350 WO469351 WO469352 WO469353 WO469354 WO469357 WO469358 WO469359 WO471335 WO471336 WO471337 WO471338 WO471339 WO471340 WO471341 WO471342 WO471344 W4468495 W4465348 W2469080 W2469062 W2469061 W2469059 W2469058 W2468858 W2465755 W2465609 W2463595 W2463592 W2463591 W2463590 W2463589 W2462285 W2462282 W2462281 W2462280 W2462279 W2459857 W2459856 W2459855
FEI Number 1000140388
Recalling Firm/
Manufacturer		 Erbe USA Inc
2225 Northwest Pkwy SE
Marietta GA 30067-8764
For Additional Information ContactErbe Field Action TEam
678-483-8499 Ext. 133
Manufacturer Reason
for Recall		Probes may rupture/burst during activation
FDA Determined
Cause 2		Process control
ActionOn 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 fieldaction.us@erbegroup.com 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 Commerce64216 units
DistributionUS Nationwide distribution, including Puerto Rico.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GEH
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