CLASS II ONGOING Device recall · Reported 25 Dec 2024 · FDA Enforcement Report

K-Systems Multiple/unknown recalled by CooperSurgical

CooperSurgical is recalling K-Systems Multiple/unknown, distributed in 14 states. The recall was initiated on 15 Nov 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUnknown 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.

Quantity recalled34 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0692-2025
FDA event ID: 95741
Recalling firm: CooperSurgical, Trumbull, CT
Classification: Class II
Status: Ongoing
Recall initiated: 15 Nov 2024
FDA classified: 18 Dec 2024
Reported: 25 Dec 2024
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Temperature Abuse
Device type: Patient Monitors

Timeline

15 Nov 2024	Recall initiated by company
18 Dec 2024	Classified by FDA	+33 days
25 Dec 2024	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for 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.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

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

Where it was distributed

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

California Delaware Idaho Illinois Indiana Massachusetts Montana North Carolina New Jersey New York Pennsylvania South Dakota Texas Virginia

Questions about this recall

Is K-Systems Multiple/unknown recalled?

Yes. CooperSurgical recalled K-Systems Multiple/unknown on 15 Nov 2024. The recall is Class II and its status is Ongoing. Recall number Z-0692-2025.

Why was it recalled?

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.

Which lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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