FDA Device Recall Z-1566-2026

Erbe USA Inc · Marietta, GA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical use

Lot / serial / GTIN: UDI: 04050147021785/ 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

Quantity: 33390 units

Reason for recall

Probes may rupture/burst during activation

Recall record

Recall number: Z-1566-2026
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: US Nationwide distribution, including Puerto Rico.
Recall initiated: 2026-02-12
Classified by FDA Center: 2026-03-20
FDA published: 2026-04-01
Recalling firm: Erbe USA Inc
Firm location: Marietta, GA

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All device recalls