Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and… — Class II medical device recall Z-2307-2021
Terminated recall by CooperSurgical, Inc., reported 2021-08-25, distributed in GA. Units are displaying output readings that differ from the measurements taken using a Gas Analyzer. When the di
| Recall number | Z-2307-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2021-06-30 |
| Classified | 2021-08-16 |
| Reported by FDA | 2021-08-25 |
| Terminated | 2022-11-21 |
| Distributed | GA |
| Countries outside the US | AE, BE, BG, BH, CH, CZ, DE, DK, EE, EG, ES, FR, GB, GH, GR, HK, HU, IL, IN, IT, JO, JP, KR, KW, LB, NL, NO, PL, PT, RO, RU, SA, SE, SG, TH, TN, TR, TW, UA, VN |
| Quantity | 421 units |
| Serial numbers | 531540, 531541, 531542, 531543, 531544, 531545, 531546, 531547, 531548, 531549, 531550, 531551, 531552, 531553, 531554, 531555, 531556, 531557, 531558, 531559, 531560, 531561, 531562, 531563, 531564 and 405 more |
| Model numbers | 3.641.831.153, K22200-110, K22200-230, K22400-110, K22400-230, K54019-2, K59500, K59700, K60000 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2307-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.