FDA Device recall Z-2307-2021
Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following in…
- FDA Device
- Class II
- terminated
- Published 2021-08-25
On 2021-08-25 the FDA classified a Class II recall of Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following in… by Coopersurgical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2307-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-06-30 |
| Published | 2021-08-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Coopersurgical |
| Distribution | GA |
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
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.
Identifiers
| code_info | Serial Numbers: 531540 531541 531542 531543 531544 531545 531546 531547 531548 531549 531550 531551 531552 531553 53155…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 531565 531566 531567 531568 531569 531570 531571 531572 531573 531574 531575 531576 531577 531578 531579 531580 531581 531582 531583 531584 531585 531586 531587 531588 531589 531590 531591 531597 531598 531599 531600 531601 531602 531603 531604 531605 531606 531607 531608 531609 531610 531611 531612 531613 531614 531615 531616 531617 531618 531619 531620 531621 531622 531623 531624 531625 531626 531627 531628 531629 531630 531631 531632 531633 531634 531635 531636 531637 531638 531639 531640 531641 531642 531643 531644 531645 531646 531647 531648 531649 531650 531651 531652 531653 531654 531655 531656 531657 531658 531659 531660 531661 531662 531663 531664 531665 531667 531668 531669 531670 531671 531672 531673 531674 531675 531676 531677 531678 531679 531690 531691 531692 531693 531694 531695 5316 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2307-2021%22
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