Z-0223-2023Class II

NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540

Name: Z-0223-2023 NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
Creator: CooperSurgical, Inc.
Published: 2022-10-20
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2022-10-20 / Open, Classified

FDA source

CooperSurgical, Inc. began a recall of NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540 on 2022-10-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0223-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-20
Posted: 2022-11-10
Recalling firm: CooperSurgical, Inc.
Product: NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
Product code: JAY Support, Breathing Tube
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.
FDA root cause: Under Investigation by firm
Action: On October 20, 2022, the firm notified affected customers via "URGENT: MEDICAL DEVICE FIELD SAFETY NOTICE" letters dated 10/7/2022. Customers were instructed to quarantine all affected product and complete the appropriate version of the attached form (Customer Acknowledgement Form or Distributor Acknowledgement Form). Once completed, return the form to CooperSurgical as indicated at the top of the form. Note: Even if you do not have any affected product in your inventory (or have not distributed any affected product to customers), please complete and return the enclosed form so that we may document receipt of this FSN. CooperSurgical will then arrange for the return of the affected product at no additional cost to the customer. Customers will receive a credit for returned product. If you have any questions, please feel free to reach us at 203-601-5200 ext. 3300 or [email protected].
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0223-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0223-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-16	2022-11-10

Product code JAY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)