# FDA recall Z-2307-2021

> **CooperSurgical, Inc.** · Class II · device recall initiated 2021-06-30.

## Product

Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and  G603 Work Chambers  Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].

## Reason for recall

Units are displaying output readings that differ from the measurements taken using a Gas Analyzer.  When the display is reading a target setting of 5%, an external meter is reading between 3% and 12% and the Incubator does not alarm. May result in loss of embryo during storage.

## Distribution

Only Foreign: Bahrain, Belgium, Bulgaria, Czech Republic Denmark, Egypt, Estonia, France, Georgia, Germany, Ghana, Great Britain, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Netherlands, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates and Vietnam.

## Key facts

- **Recall number:** Z-2307-2021
- **Recalling firm:** CooperSurgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-30
- **Report date:** 2021-08-25
- **Termination date:** 2022-11-21

- **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-2307-2021

## Citation

> AI Analytics. FDA recall Z-2307-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2307-2021. Source: US FDA. Licensed CC0.

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