# FDA recall Z-0223-2023

> **CooperSurgical, Inc.** · Class II · device recall initiated 2022-10-20.

## 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.

## 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.

## Key facts

- **Recall number:** Z-0223-2023
- **Recalling firm:** CooperSurgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-10-20
- **Report date:** 2022-11-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Trumbull, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0223-2023

## Citation

> AI Analytics. FDA recall Z-0223-2023. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0223-2023. Source: US FDA. Licensed CC0.

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