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 | Unsealed pouches. |
| Product | CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography. |
| Quantity | 1,400 units |
| Distribution | Worldwide Distribution -- USA, in the states of CA, TX, IL, MI, MS, ID, NY, FL, MD, PA, OR, GA, CO, WA, NJ, HI, and NC, including DC; and the countries of the countries of Spain, England, Holland, and United Kingdom. |
| Initiated | 2014-07-03 |
| Classified | 2014-09-05 |
| Terminated | 2015-05-28 |
| Recall number | Z-2570-2014 |
| 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-2570-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68754/
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