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 | Terminated |
| Reason | The products have been identified to contain an incorrect size Diaphragm. |
| Product | Milex Arcing Diaphragm Size 95; Model Number: MXWS95 |
| Quantity | 2 units |
| Distribution | US Distribution to the states of : OR and NY |
| Initiated | 2016-02-16 |
| Classified | 2016-03-04 |
| Terminated | 2016-03-29 |
| Recall number | Z-1054-2016 |
| 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-1054-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73329/
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