NEO-fit Neonatal Endotracheal Tube Grip — Class II medical device recall Z-0223-2023
Ongoing recall by CooperSurgical, Inc., reported 2022-11-16, distributed nationwide. Firm has received 11 complaints involving a loose or detached metal clips, including 3 cases where the metal c
| Recall number | Z-0223-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2022-10-20 |
| Classified | 2022-11-10 |
| Reported by FDA | 2022-11-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BG, BH, CA, CO, CY, DE, EC, GB, GR, HK, HU, IE, IN, IT, MT, MY, NL, NZ, PH, QA, SA, SG, TR |
| Quantity | 220,500 devices |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00888937016659 |
| Model numbers | 42-2540 |
Product
NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0223-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.