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 | A diaphragm size 80 labeled box was incorrectly packaged with a size 85. |
| Product | MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80 |
| Quantity | 200 units |
| Distribution | AK, CA, DC, FL, IL, ME, MT, NE, NJ, NM, NY, OK, OR, P A, VA, W A, and WI Foreign: CANADA, ENGLAND, and POLAND |
| Initiated | 2015-05-20 |
| Classified | 2015-06-18 |
| Terminated | 2016-01-20 |
| Recall number | Z-1814-2015 |
| 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-1814-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71329/
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