Lower risk Medical device recall · FDA · Published November 15, 2024

K-Systems G85 Mini Incubator: Overheating Risk in Assisted Reproduction

CooperSurgical recalls K-Systems G85 Mini Incubators with model K22074 that may overheat during assisted reproduction procedures, causing potential temperature control issues.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0688-2025Medical device K-Systems ›

Lower-risk recall

The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.

Take action

Contact the company

Recalling firmCooperSurgical, Inc.95 Corporate Dr · Trumbull, CT 06611-1350

✎ GovInfoNow plain-language explainer

CooperSurgical recalls K-Systems G85 Mini Incubators with model K22074 due to possible overheating. This could lead to incorrect temperature settings during sensitive reproductive procedures, though the device alarms when temperatures exceed the set point. Read more at govinfonow.com/recall/53482-k-systems-g85-mini-incubator-overheating-risk-in-assisted-reproduction.

Source Summary by GovInfoNow · govinfonow.com/recall/53482-k-systems-g85-mini-incubator-overheating-risk-in-assisted-reproduction · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0688-2025

Cite this page

“K-Systems G85 Mini Incubator: Overheating Risk in Assisted Reproduction.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53482-k-systems-g85-mini-incubator-overheating-risk-in-assisted-reproduction. Based on FDA recall #Z-0688-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0688-2025%22&limit=1).

CooperSurgical, Inc. recalled K-Systems G85 Mini Incubators due to potential overheating hazards, the FDA said on Nov. 15, 2024. The device may exceed desired set temperatures during use.

How to tell if you have it

Brand: K-Systems
Product Name: G85 Mini Incubator
Model/Catalog Number: K22074
Serial Numbers: 2244KH01, 2244KH02, 2244KH03, 2244KH04, 2244KH05, 2244KH06, 2244KH07, 2244KH08, 2244KH09, 2244KH10, 2313KH01, 2313KH02, 2313KH03, 2313KH04, 2313KH05, 2313KH06, 2313KH07, 2313KH08, 2313KH09, 2313KH10, 2320KH21, 2320KH22, 2320KH23, 2320KH24, 2320KH25, 2320KH26, 2320KH27, 2320KH28, 2320KH29, 2320KH30, 2321KH16, 2321KH17, 2321KH18, 2321KH19, 2321KH20

The hazard

The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.

Context

GovInfoNow's records show CooperSurgical, Inc. has issued 37 other recalls since Oct. 6, 2017. Recent brand recalls include a July 31, 2024, recall of Silver-Plated Copper Sims Uterine Sounds for incorrect part number laser marking and a June 11, 2025, recall of HSG Procedure Trays containing non-sterile iodine pouches mislabeled as sterile. Other recent recalls of similar products include the July 13, 2026, Gentherm Blanketrol II and III models for overheating risk and the June 11, 2026, OXOS MC2 Portable X-Ray System for a defective circuit board that overheats.

How to tell if you have this one

Check for model number K22074 on the incubator. The serial numbers listed include 2244KH01 through 2321KH20. This product was sold for assisted reproductive procedures.

Brand
K-Systems
Category
Medical device

FDA recall event · 6 products

All 6 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
States: NC, NJ, TX, VA, IL, NY, CA, PA Please note: The countries below, excluding Iraq, all consider these devices to be "lab equipment", not medical devices and are not subject to classification or recall guidelines. Countries: AT, AU, BE, BH, BR, CA, CH, CN, CZ, DE, EG, ES, ET, FR, GB, GH, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LB, MA, MK, MT, NL, NO, PE, PH, PK, PT, QA, RO, RS, SA, SD, SE, SO,TR, TW, TZ, US, ZA

Recall number	Product, codes & lots	Quantity
Z-0687-2025	Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A; Version or Model: K22065; Primary DI Number: 00888937025040; Serial Numbers: 2202KH46, 2202KH47, 2202KH48, 2202KH49, 2202KH50, 2202KH51, 2202KH52, 2202KH53, 2202KH54, 2202KH55, 2208KH01, 2208KH02, 2208KH03, 2208KH04, 2208KH05, 2208KH06, 2208KH07, 2208KH08, 2208KH09, 2208KH10, 2208KH11, 2208KH12, 2208KH13, 2208KH14, 2208KH15, 2208KH16, 2208KH17, 2208KH18, 2208KH19, 2208KH20, 2235KH01, 2235KH02, 2235KH03, 2235KH04, 2235KH05, 2235KH06, 2235KH07, 2235KH08, 2235KH09, 2235KH10, 2235KH11, 2235KH12, 2235KH13, 2235KH14, 2235KH15, 2235KH16, 2235KH17, 2235KH18, 2235KH19, 2235KH20, 2239KH11, 2239KH12, 2239KH13, 2239KH14, 2239KH15, 2239KH16, 2239KH17, 2239KH18, 2239KH19, 2239KH20, 2242KH11, 2242KH12, 2242KH13, 2242KH14, 2242KH15, 2242KH16, 2242KH17, 2242KH18, 2242KH19, 2242KH20, 2242KH21, 2242KH22, 2242KH23, 2242KH24, 2242KH25, 2246KH01, 2246KH02, 2246KH03, 2246KH04, 2246KH05, 2246KH06, 2246KH07, 2246KH08, 2246KH09, 2246KH10, 2246KH11, 2246KH12, 2246KH13, 2246KH14, 2246KH15, 2246KH16, 2246KH17, 2246KH18, 2246KH19, 2246KH20, 2246KH21, 2246KH22, 2246KH23, 2246KH24, 2246KH25, 2246KH26, 2246KH27, 2246KH28, 2246KH29, 2246KH30, 2246KH31, 2246KH32, 2246KH33, 2246KH34, 2246KH35, 2246KH36, 2246KH37, 2246KH38, 2246KH39, 2246KH40, 2246KH41, 2246KH42, 2246KH43, 2246KH44, 2246KH45, 2246KH46, 2246KH47, 2246KH48, 2246KH49, 2246KH50, 2246KH51, 2246KH52, 2246KH53, 2246KH54, 2246KH55, 2303KH01, 2303KH02, 2303KH03, 2303KH04, 2303KH05, 2303KH06, 2303KH07, 2303KH08, 2303KH09, 2303KH10, 2303KH11, 2303KH12, 2303KH13, 2303KH14, 2303KH15, 2303KH16, 2303KH17, 2303KH18, 2303KH19, 2303KH20, 2303KH21, 2303KH22, 2303KH23, 2303KH24, 2303KH25, 2303KH26, 2303KH27, 2303KH28, 2303KH29, 2303KH30, 2303KH31, 2303KH32, 2303KH33, 2303KH34, 2303KH35, 2303KH36, 2303KH37, 2303KH38, 2303KH39, 2303KH40, 2311KH01, 2311KH02, 2311KH03, 2311KH04, 2311KH05, 2311KH06, 2311KH07, 2311KH08, 2311KH09, 2311KH10, 2311KH11, 2311KH12, 2311KH13, 2311KH14, 2311KH15, 2313KH11, 2313KH12, 2313KH13, 2313KH14, 2313KH15, 2313KH16, 2313KH17, 2313KH18, 2313KH19, 2313KH20, 2313KH21, 2313KH22, 2313KH23, 2313KH24, 2313KH25, 2316KH01, 2316KH02, 2316KH03, 2316KH04, 2316KH05, 2316KH06, 2316KH07, 2316KH08, 2316KH09, 2316KH10, 2316KH11, 2316KH12, 2316KH13, 2316KH14, 2316KH15, 2322KH11, 2322KH12, 2322KH13, 2322KH14, 2322KH15, 2322KH16, 2322KH17, 2322KH18, 2322KH19, 2322KH20, 2322KH21, 2322KH22, 2322KH23, 2322KH24, 2322KH25, 2326KH01, 2326KH02, 2326KH03, 2326KH04, 2326KH05, 2326KH06, 2326KH07, 2326KH08, 2326KH09, 2326KH10, 2326KH11, 2326KH12, 2326KH13, 2326KH14, 2326KH15, 2326KH16, 2326KH17, 2326KH18, 2326KH19, 2326KH20, 2327KH30, 2327KH31, 2327KH32, 2327KH33, 2327KH34, 2327KH35, 2327KH36, 2327KH37, 2327KH38, 2327KH39, 2327KH40, 2327KH41, 2327KH42, 2327KH43, 2327KH44, 2332KH11, 2332KH12, 2332KH13, 2332KH14, 2332KH15, 2332KH16, 2332KH17, 2332KH18, 2332KH19, 2332KH20.	106 units
Z-0688-2025	Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No; Version or Model: K22074; Primary DI Number: 00888937025057; Serial Numbers: 2244KH01 , 2244KH02 , 2244KH03 , 2244KH04 , 2244KH05 , 2244KH06 , 2244KH07 , 2244KH08 , 2244KH09 , 2244KH10 , 2313KH01 , 2313KH02 , 2313KH03 , 2313KH04 , 2313KH05 , 2313KH06 , 2313KH07 , 2313KH08 , 2313KH09 , 2313KH10 , 2320KH21 , 2320KH22 , 2320KH23 , 2320KH24 , 2320KH25 , 2320KH26 , 2320KH27 , 2320KH28 , 2320KH29 , 2320KH30 , 2321KH16 , 2321KH17 , 2321KH18 , 2321KH19 , 2321KH20,	37 units
Z-0689-2025	Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No; Version or Model: K23054; Primary DI Number: 00888937025071; Serial Numbers: 2218KH46 , 2218KH47 , 2218KH48 , 2218KH49 , 2218KH50 , 2218KH51 , 2218KH52 , 2218KH53 , 2218KH54 , 2218KH55 , 2218KH56 , 2218KH57 , 2218KH58 , 2218KH59 , 2218KH60 , 2233KH11 , 2233KH12 , 2233KH13 , 2233KH14 , 2233KH15 , 2233KH16 , 2233KH17 , 2233KH18 , 2233KH19 , 2233KH20 , 2235KH31 , 2235KH32 , 2235KH33 , 2235KH34 , 2235KH35 , 2235KH36 , 2235KH37 , 2235KH38 , 2235KH39 , 2235KH40 , 2237KH11 , 2237KH12 , 2237KH13 , 2237KH14 , 2237KH15 , 2237KH16 , 2237KH17 , 2237KH18 , 2237KH19 , 2237KH20 , 2242KH01 , 2242KH02 , 2242KH03 , 2242KH04 , 2242KH05 , 2242KH06 , 2242KH07 , 2242KH08 , 2242KH09 , 2242KH10 , 2250KH01 , 2250KH02 , 2250KH03 , 2250KH04 , 2250KH05 , 2250KH06 , 2250KH07 , 2250KH08 , 2250KH09 , 2250KH10 , 2309KH41 , 2309KH42 , 2309KH43 , 2309KH44 , 2309KH45 , 2309KH46 , 2309KH47 , 2309KH48 , 2309KH49 , 2309KH50 , 2320KH01 , 2320KH02 , 2320KH03 , 2320KH04 , 2320KH05 , 2320KH06 , 2320KH07 , 2320KH08 , 2320KH09 , 2320KH10 , 2322KH01 , 2322KH02 , 2322KH03 , 2322KH04 , 2322KH05 , 2322KH06 , 2322KH07 , 2322KH08 , 2322KH09 , 2322KH10 , 2337KH01, 2337KH02, 2337KH03, 2337KH04, 2337KH05, 2337KH06, 2337KH07, 2337KH08, 2337KH09, 2337KH10,	22 units
Z-0690-2025	Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No; Version or Model: K23055; Primary DI Number: 00888937025064; Serial Numbers: 2223KH01 , 2223KH02 , 2223KH03 , 2223KH04 , 2223KH05 , 2223KH06 , 2223KH07 , 2223KH08 , 2223KH09 , 2223KH10 , 2235KH21 , 2235KH22 , 2235KH23 , 2235KH24 , 2235KH25 , 2235KH26 , 2235KH27 , 2235KH28 , 2235KH29 , 2235KH30 , 2237KH01 , 2237KH02 , 2237KH03 , 2237KH04 , 2237KH05 , 2237KH06 , 2237KH07 , 2237KH08 , 2237KH09 , 2237KH10 , 2250KH11 , 2250KH12 , 2250KH13 , 2250KH14 , 2250KH15 , 2250KH16 , 2250KH17 , 2250KH18 , 2250KH19 , 2250KH20 , 2303KH41 , 2303KH42 , 2303KH43 , 2303KH44 , 2303KH45 , 2303KH46 , 2303KH47 , 2303KH48 , 2303KH49 , 2303KH50 , 2309KH31 , 2309KH32 , 2309KH33 , 2309KH34 , 2309KH35 , 2309KH36 , 2309KH37 , 2309KH38 , 2309KH39 , 2309KH40 , 2311KH16 , 2311KH17 , 2311KH18 , 2311KH19 , 2311KH20 , 2311KH21 , 2311KH22 , 2311KH23 , 2311KH24 , 2311KH25 , 2320KH41 , 2320KH42 , 2320KH43 , 2320KH44 , 2320KH45 , 2320KH46 , 2320KH47 , 2320KH48 , 2320KH49 , 2320KH50 , 2324KH33 , 2324KH34 , 2324KH35 , 2324KH36 , 2324KH37 , 2324KH38 , 2324KH39 , 2324KH40 , 2324KH41 , 2324KH42 , 2327KH20 , 2327KH21 , 2327KH22 , 2327KH23 , 2327KH24 , 2327KH25 , 2327KH26 , 2327KH27 , 2327KH28 , 2327KH29 , 2333KH01, 2333KH02, 2333KH03, 2333KH04, 2333KH05, 2333KH06, 2333KH07, 2333KH08, 2333KH09, 2333KH10, 2333KH21, 2333KH22, 2333KH23, 2333KH24, 2333KH25, 2333KH26, 2333KH27, 2333KH28, 2333KH29, 2333KH30, 2333KH31, 2333KH32, 2333KH33, 2333KH34, 2333KH35, 2335KH51, 2335KH52, 2335KH53, 2335KH54, 2335KH55, 2335KH56, 2335KH57, 2335KH58, 2335KH59, 2335KH60, 2335KH61, 2335KH62, 2335KH63, 2335KH64, 2335KH65, 2335KH66, 2335KH67, 2335KH68, 2335KH69, 2335KH70, 2335KH71, 2335KH72, 2335KH73, 2335KH74, 2335KH75, 2335KH76, 2335KH77, 2335KH78, 2335KH79, 2335KH80, 2335KH81, 2335KH82, 2335KH83, 2335KH84, 2335KH85, 2335KH86, 2335KH87, 2335KH88, 2335KH89, 2335KH90, 2345KH11, 2345KH12, 2345KH13, 2345KH14, 2345KH15, 2345KH16, 2345KH17, 2345KH18, 2345KH19, 2345KH20, 2345KH21, 2345KH22, 2345KH23, 2345KH24, 2345KH25,	35 units
Z-0691-2025	Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A; Version or Model: K24012; Primary DI Number: 00888937025026; Serial Numbers: 2234KH01, 2234KH02, 2234KH03, 2234KH04, 2234KH05, 2234KH06, 2234KH07, 2234KH08, 2234KH09, 2234KH10, 2235KH41, 2235KH42, 2235KH43, 2235KH44, 2235KH45, 2235KH46, 2235KH47, 2235KH48, 2235KH49, 2235KH50, 2235KH51, 2235KH52, 2235KH53, 2235KH54, 2235KH55, 2235KH56, 2235KH57, 2235KH58, 2235KH59, 2235KH60, 2243KH01, 2243KH02, 2243KH03, 2243KH04, 2243KH05, 2243KH06, 2243KH07, 2243KH08, 2243KH09, 2243KH10, 2243KH11, 2243KH12, 2243KH13, 2243KH14, 2243KH15, 2243KH16, 2243KH17, 2243KH18, 2243KH19, 2243KH20, 2307KH01, 2307KH02, 2307KH03, 2307KH04, 2307KH05, 2307KH06, 2307KH07, 2307KH08, 2307KH09, 2307KH10, 2320KH11, 2320KH12, 2320KH13, 2320KH14, 2320KH15, 2320KH16, 2320KH17, 2320KH18, 2320KH19, 2320KH20, 2337KH11, 2337KH12, 2337KH13, 2337KH14, 2337KH15, 2337KH16, 2337KH17, 2337KH18, 2337KH19, 2337KH20, 2340KH01, 2340KH02, 2340KH03, 2340KH04, 2340KH05,	43 units
Z-0692-2025	Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A; Unknown product distributed in India and Australia as lab equipment. Version or Model: Multiple/unknown; Primary DI Number: unknown; Serial Numbers: unknown. NOTE: These devices are one of the five (5) noted affected Part Numbers, so the intended use, etc. will be one of those other devices. As stated above, traceability was not a concern due to the classification of these devices in those regions.	34 units

Based on the official FDA remedy

What to do — step by step

Check Device Temperature
Monitor the incubator for alarms indicating overheating, as the device will alert when temperatures exceed the set point.

Where it went and when

Where it was distributed

Distributed in 8 states, and outside the U.S.

FDA distribution: “States: NC, NJ, TX, VA, IL, NY, CA, PA Please note: The countries below, excluding Iraq, all consider these devices to be "lab equipment", not medical devices and are not subject to classification or recall guidelines. Countries: AT, AU,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Illinois, New Jersey, New York, North Carolina, Pennsylvania, Texas, Virginia.

Recall timeline

FDA published this recall 40 days after the firm started it.

Nov 15, 2024Firm started the recall
Dec 18, 2024FDA classified it Class II
Dec 25, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/53482-k-systems-g85-mini-incubator-overheating-risk-in-assisted-reproduction">K-Systems G85 Mini Incubator: Overheating Risk in Assisted Reproduction (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0688-2025 (November 15, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0688-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.