Device recall: Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
Class I FDA enforcement event 98429. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Probes may rupture/burst during activation
Class I, in the words of FDA
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
Erbe USA Inc started this device recall on 12 Feb 2026. The firm address in the FDA record is in Marietta, GA. FDA put the recall in Class I. FDA event 98429 has 3 product records. The first FDA enforcement report date is 1 Apr 2026. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution, including Puerto Rico.
Recalling firm
Erbe USA Inc, Marietta, GA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1566-2026 | Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use | 64216 units | Class I | Ongoing | 1 Apr 2026 |
| Z-1567-2026 | Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use | 8,284 units | Class I | Ongoing | 1 Apr 2026 |
| Z-1568-2026 | Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use | 3603 units | Class I | Ongoing | 1 Apr 2026 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2026
- 572
- Share of these events in Class I
- 12%
- Product records in this event
- 3Median of the firm: 3
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 26 Jun 2026 | ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000 Event 99341 | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1566-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 98429. https://recallregister.com/fda/i/98429/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution, including Puerto Rico.
- What quantity of product is in FDA event 98429?
- The event has 3 product records. The first record gives this quantity:
64216 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2026 have the same class?
- 12% of the 572 device events that started in 2026 are in Class I.