Class II — CooperSurgical, Inc.
| Recalling firm | COOPERSURGICAL, INC. |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Products in this lot may have compromised barrier seals, introducing a risk to sterility. |
| Product | VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap. |
| Quantity | 2,340 (US only) |
| Distribution | Domestic distribution to AZ, CA, FL, IL, MI, MO, NY, OR, TX, and WV. No foreign distribution. |
| Initiated | 2022-04-01 |
| Classified | 2022-05-17 |
| Recall number | Z-1108-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — CooperSurgical, Inc. (Z-1108-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90042/
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