# FDA recall Z-1823-2022

> **CooperSurgical, Inc.** · Class II · device recall initiated 2022-08-12.

## Product

Humidifier bottle and syringe filter kit (6 count of each) for the BT37  Mark II Benchtop Incubator (AY200246)

## Reason for recall

There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the sterile barrier may result in use of an unsterilized device, which may cause contamination and degradation or loss of embryo during incubation.

## Distribution

Domestic distribution to the following states: AL AZ CA CT DE FL GA HI IL KS MA MI MN MO NJ NY OH OR SC TX VA VT WA WI WV  Foreign distribution to Barbados, Canada, Chile, Micronesia Federate, and Panama.

## Key facts

- **Recall number:** Z-1823-2022
- **Recalling firm:** CooperSurgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-12
- **Report date:** 2022-10-05

- **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-1823-2022

## Citation

> AI Analytics. FDA recall Z-1823-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1823-2022. Source: US FDA. Licensed CC0.

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