CryoTreQ- Aa disposable handheld instrument intended for ophthalmic… — Class II medical device recall Z-1497-2023
Ongoing recall by Beaver Visitec International, Inc., reported 2023-05-10, distributed nationwide. Device suddenly and forcefully disassembled after cryotherapy, potential for long-term or permanent impairment
| Recall number | Z-1497-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beaver Visitec International, Inc., Waltham, MA, United States |
| Recall initiated | 2023-03-17 |
| Classified | 2023-05-02 |
| Reported by FDA | 2023-05-10 |
| Distributed | Nationwide (US) |
| Quantity | 501 |
| UPC / GTIN / UDI-DI | 08719214223458 |
| Lot numbers | 20214366, 20214367, 20214450, 20214518, 20214522, 20214615, 20214744, 20214745, 20214961, 20214962, 20215203, 20215204, 20215479, 20216010, 20216263, 20216264, 20221083, 20221140, 20221364, 20221746, 20221894, 20222365, 20227950, 20227951, 20227952, 20228408, 20228657, 20228897, 20228898, 20229034, 20229138, 20229334, 20229460, 20229630, 20229748, 20230261 |
| Model numbers | CT00.D01 |
Product
CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures by evaporation of N2O that can be utilized to perform cryotherapy based on the destruction of tissue by extreme cold to locally perform cryocoagulation on tissue. Ref: CT00.D01
Reason for recall
Device suddenly and forcefully disassembled after cryotherapy, potential for long-term or permanent impairment of a patient or user if a CryoTreq device suddenly or forcefully disassembles during a cryosurgery procedure.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1497-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.