VITRIGUARD — Class II medical device recall Z-1108-2022
Ongoing recall by CooperSurgical, Inc., reported 2022-05-25, distributed in AZ, CA, FL, IL, MI, MO, NY, OR…. Products in this lot may have compromised barrier seals, introducing a risk to sterility.
| Recall number | Z-1108-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2022-04-01 |
| Classified | 2022-05-17 |
| Reported by FDA | 2022-05-25 |
| Distributed | AZ, CA, FL, IL, MI, MO, NY, OR, TX, WV |
| Quantity | 2,340 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00888937014792, 20888937014796 |
| Lot numbers | 264453 |
| Model numbers | 43782001 |
Product
VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.
Reason for recall
Products in this lot may have compromised barrier seals, introducing a risk to sterility.
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-1108-2022. 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.