Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen ...
FDA Device Recall #Z-2307-2021 — Class II — June 30, 2021
Recall Summary
| Recall Number | Z-2307-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 30, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | CooperSurgical, Inc. |
| Location | Trumbull, CT |
| Product Type | Devices |
| Quantity | 421 units |
Product Description
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 Pattern
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.
Lot / Code Information
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 531696 531697 531698 531699 531700 531701 531702 531703 531704 531705 531706 531707 531708 531709 531710 531711 531712 531713 531714 531715 531716 531717 531718 531719 531721 531722 531723 531724 531725 531726 531727 531728 531729 531730 531731 531732 531733 531734 531735 531736 531737 531738 531739 531740 531741 531742 531743 531744 531745 531746 531747 531748 531749 532001 532034 532035 532036 532037 532038 532039 532040 532041 532042 532043 532044 532045 532046 532047 532048 532052 532053 532054 532070 532071 532072 532073 532074 532075 532076 532077 532079 532080 532081 532082 532083 532084 532085 532086 532087 532088 532089 532090 532091 532092 532103 532104 532105 532106 532107 532108 532109 532110 532111 532112 532113 532114 532115 532116 532117 532118 532119 532120 532121 532122 532123 532124 532125 532126 532127 532128 532129 532130 532131 532132 532134 532135 532136 532137 532138 532139 532140 532141 532142 532143 532144 532145 532146 532147 532148 532149 532150 532151 532152 540659 540660 540661 540662 540663 540665 540666 540667 540668 540669 540670 540671 540672 540673 540674 540675 540676 540677 540678 540679 540680 540681 540682 540683 540684 540685 540686 540687 540688 540689 540691 540692 540693 540694 540695 540696 540697 540698 540699 540700 540701 540702 540708 540710 540711 540712 540713 540714 540715 540716 540717 540718 540719 540720 540721 540723 540724 540725 540726 540727 540730 540731 540732 540733 540734 540735 540736 540737 540738 540739 540740 540741 540742 540743 540744 540745 540746 540747 560830 560831 560900 560901 560930 560952 560953 560954 560967 560968 560969 560970 560971 560972 560973 560974 560975 560976 560977 560978 560979 560980 560981 560983 560984 560985 560986 560987 560988 560989 560990 560991 560992 560993 560994 560995 560996 560997 560998 561000 561001 561002 561003 561004 561005 561006 561007 561008 561009 561010 561011 561012 561019 561025 561026 561027 561028 561030 561031 561032 561033 561034 561035 561036 561040 582528 582531 582533 582534
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Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.