Flexible Cryoprobe (OD 1.7mm, L1.15mm)
Medical device recall Z-1567-2026. 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
- 8,284 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 1.7mm, L1.15mm) REF: 20402-410. For surgical use
8,284 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 886 characters
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
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.”
- 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.