Oxygen Sensor
Medical device recall Z-2307-2021. Published in FDA’s Enforcement Report on Aug 25, 2021.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 25, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 421 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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].
421 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,997 characters
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…
FDA’s list runs to 3,025 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 30, 2021.
- FDA classified it on Aug 16, 2021.
- FDA’s Enforcement Report published it on Aug 25, 2021.
- FDA terminated it on Nov 21, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- CooperSurgical, Inc., of Trumbull, CT.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,025 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.