Recall archive / FDA device enforcement
NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540 — FDA record Z-0223-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 20, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
- 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.
- Classification
- Class II
- Recalling firm
- CooperSurgical, Inc.
- Quantity
- 220,500 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0223-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot/Serial Number UDI-DI (GTIN-14 - not yet added to GUDID database) 272992 00888937016659 269476 00888937016659 269477 00888937016659 269478 00888937016659 269479 00888937016659 269480 00888937016659 269482 00888937016659 269483 00888937016659 274957 00888937016659 274958 00888937016659 274960 00888937016659 274961 00888937016659 286859 00888937016659 286861 00888937016659 286863 00888937016659 292881 00888937016659 292883 00888937016659 292888 00888937016659 292889 00888937016659 292900 00888937016659 292901 00888937016659 292903 00888937016659 296236 00888937016659 296238 00888937016659 297033 00888937016659 297034 00888937016659 297035 00888937016659 298049 00888937016659 298055 00888937016659 298054 00888937016659 298056 00888937016659 298062 00888937016659 303771 00888937016659 303772 00888937016659 303950 00888937016659 304053 00888937016659 304363 00888937016659 305019 00888937016659 305020 00888937016659 307724 00888937016659 306339 00888937016659 306341 00888937016659 307728 00888937016659 307726 00888937016659 307730 00888937016659 308591 00888937016659 309910 00888937016659 309912 00888937016659 313142 00888937016659 311533 00888937016659 314675 00888937016659 315626 00888937016659 315810 00888937016659 318970 00888937016659 316866 00888937016659 320400 00888937016659 |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Nov 16, 2022
- Recall initiation date
- Oct 20, 2022
- Center classification date
- Nov 10, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.