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 | Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure |
| Product | CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes |
| Quantity | 90 units |
| Distribution | Nationwide Foreign: BELGIUM CANADA MALAYSIA NETHERLANDS SPAIN SWEDEN SWITZERLAND |
| Initiated | 2022-03-31 |
| Classified | 2023-12-06 |
| Recall number | Z-0504-2024 |
| 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-0504-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93239/
Alerts for COOPERSURGICAL, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.