The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0692-2025·Announced 2024-12-25

K-Systems Incubator Device Recall: Temperature May Exceed Desired Setting

CooperSurgical is recalling 34 K-Systems incubator devices used in assisted reproduction procedures. The warming surfaces may exceed the desired set temperature, though the device will alarm if this occurs.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This recall involves a medical device with risk of harm to reproductive materials being processed, as temperature exceedance could damage gametes or embryos. No illnesses or injuries have been reported, and the device includes an alarm function to alert users. The score reflects FDA Class II classification with potential for harm to specialized medical materials but without documented adverse outcomes.

Plain-English summary

CooperSurgical, Inc. is recalling 34 K-Systems warming and incubation devices used in assisted reproduction procedures. These devices maintain controlled temperatures for reproductive biological materials, including gametes and embryos. The FDA classification for this recall is Class II.

The warming surfaces or incubator well temperatures of the affected devices may exceed the desired set temperature. While the device will alarm appropriately if this occurs, temperature exceedance could impact the viability of reproductive materials being processed.

The recalled devices were distributed to medical facilities in North Carolina, New Jersey, Texas, Virginia, Illinois, New York, California, and Pennsylvania. Some devices were also distributed internationally to countries that classify them as laboratory equipment.

If your facility has received one of these devices, contact CooperSurgical, Inc. immediately. Affected medical professionals should verify temperature readings during use and ensure alarms are functioning properly.

The recalled product

Product
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…
Manufacturer
CooperSurgical, Inc.
Category
Medical Device — Reproductive Equipment
Hazard
Affected units
34

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Primary DI Number: unknown
  • so the intended use
  • etc. will be one of those other devices. As stated above

Distribution

Distributed in 14 states:

Part of a larger recall action

This product is one of 6 recalled by CooperSurgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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