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 | During the manufacturing process the devices were laser-marked with the incorrect part number. |
| Product | Silver-Plated Copper Sims Uterine Sound, Part Number 64-600 |
| Quantity | 468 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, Sweden. |
| Initiated | 2024-07-31 |
| Classified | 2024-09-20 |
| Recall number | Z-3188-2024 |
| 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-3188-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95232/
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