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 | Small sized specula were incorrectly packaged in printed bags for the medium sized speculum |
| Product | McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures |
| Quantity | 9400 units |
| Distribution | Nationwide Distribution including IL, FL, GA, MA, MO, TX, and WA. |
| Initiated | 2015-04-13 |
| Classified | 2015-06-22 |
| Terminated | 2016-02-05 |
| Recall number | Z-1824-2015 |
| 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-1824-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71313/
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