NEO-fit 42-2540Recalls & reported problems
Coopersurgical, Inc. · NEO-fit Neonatal Endotracheal Tube grip · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888937016659), received between Dec 19, 2022 and Sep 21, 2026 — classified as 4 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 reports).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Oct 20, 2022Class IIOpen, Classified
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.
Z-0223-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component8
- Premature Separation2
- Loss of or Failure to Bond1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Detachment of Device or Device Component
It was reported that Homerton University Hospital experienced multiple issues with this batch of NEOfit not adhering properly, causing unplanned extubation. Multiple attempts have been made, but no additional information has been provided. 1216677-2026-00136 42-2540 NEO-fit (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840556 ↗MalfunctionApr 8, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE NEO-FIT ETT HOLDER DELAMINATED FROM ITS OWN ADHESIVE BACKING WHILE ON INFANT, NO HARM TO PATIENT BUT IT WAS A NEAR MISS. NO ADDITIONAL INFORMATION IS AVAILABLE. 42-2540 NEO-FIT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24817070 ↗InjuryMar 23, 2026Detachment of Device or Device Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24662728 ↗InjuryMar 23, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EXTUBATION DUE TO SEPARATION OF THE ADHESIVE USED TO SECURE THE DEVICE. NO ADDITIONAL HARM WAS NOTED. ATTEMPTS WERE MADE, BUT NO ADDITIONAL INFORMATION WAS AVAILABLE. 42-2540 NEO-FIT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24662727 ↗InjuryMar 23, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EXTUBATION DO TO SEPARATION OF THE ADHESIVE USED TO SECURE THE DEVICE. NO ADDITIONAL HARM WAS NOTED. ATTEMPTS WERE MADE, BUT NO ADDITIONAL INFORMATION WAS AVAILABLE. (B)(4) NEO-FIT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24662719 ↗MalfunctionJan 6, 2026Detachment of Device or Device Component; Material Split, Cut or Torn; Premature Separation
NEO-FIT WAS FOUND TO BE LOOSE RESULTING IN THE ENDOTRACHEAL TUBE (ET) BECOMING DISLODGED. IT WAS NOTED THAT THE NEO-FIT WAS PARTLY LIFTING OFF ON ONE SIDE OF FACE. THE TAPE THAT IS SUPPOSED TO HOLD THE NEO-FIT IN PLACE HAD SEPARATED IN TWO AS ONE PART WAS STILL STUCK DOWN AND OTHER PART WAS LIFTED. THE NEO-FIT WAS REMOVED BY THE STAFF MEMBER WHILE THE DOCTOR HELD THE ET TUBE IN PLACE. ET TUBE THEN SECURED WITH NEW NEOFIT AND TUBE IN CORRECT POSITION. NO PATIENT HARM REPORTED. 42-2540 NEOFIT 2025-12-0000378.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23974269 ↗MalfunctionNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23452960 ↗MalfunctionOct 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20352746 ↗MalfunctionDec 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE METAL GRIPS ARE BROKEN OFF, BUT NOT WHILE IN USE, ONLY WHILE STORED. NEO-FIT NEONATAL ENDOTRAC 42-2540, E-COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16002427 ↗
Other Support, Breathing Tube devices
- Portex 100/503/200Icu Medical, Inc. · SUPPORT, BREATHING TUBE3 reports
- Universal Bite Block, Adult 11160B&B Medical Technologies · Support, Breathing Tube1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page