Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm)
Medical device recall Z-1566-2026. Published in FDA’s Enforcement Report on Apr 1, 2026.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 1, 2026. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 64216 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Probes may rupture/burst during activation
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
64216 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,994 characters
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…
FDA’s list runs to 3,838 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide distribution, including Puerto Rico.
The states and territories these words name
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 12, 2026.
- FDA classified it on Mar 20, 2026.
- FDA’s Enforcement Report published it on Apr 1, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Erbe USA Inc, of Marietta, GA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,838 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.