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 | Firm has received 11 complaints involving a loose or detached metal clips, including 3 cases where the metal clip was ingested by the patient, and 3 cases where the metal clip was removed from the patient's mouth. In one case, the patient suffered a laceration to the throat. |
| Product | NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540 |
| Quantity | 220,500 devices |
| Distribution | Worldwide distribution: US (Nationwide) including Puerto Rico; and countries (foreign) of: Australia, Bahrain, Belgium, Bulgaria, Canada, Colombia, Cyprus, Ecuador, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Malaysia, Malta, Netherlands, New Zealand, Saudi Arabia, Singapore, Turkey, Philippines, Qatar, United Arab Emirates, and United Kingdom. |
| Initiated | 2022-10-20 |
| Classified | 2022-11-10 |
| Recall number | Z-0223-2023 |
| 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-0223-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91047/
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