High FDA (Devices)·Z-0689-2025·Announced 2024-12-25

K-Systems T47 Warming Plate may exceed desired temperatures

The K-Systems T47 Warming Plate has a temperature control defect where warming surfaces may exceed desired set temperatures. CooperSurgical is recalling 22 affected units distributed to fertility clinics.

What this means for you

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 is an FDA Class II recall of a medical device with no reported illnesses or injuries. The hazard is a risk-of-harm scenario where improper temperature control could compromise the viability of reproductive biological materials. The device includes an alarm system for mitigation, but the risk to assisted reproduction outcomes justifies a High severity classification.

Plain-English summary

CooperSurgical, Inc. is recalling 22 units of the K-Systems T47 Warming Plate (Model K23054), a medical device used in fertility and assisted reproduction procedures. The device is designed to maintain controlled warming and incubation conditions for reproductive biological materials, including gametes and embryos, during examination and processing.

The FDA has identified a defect in which the warming surfaces or incubator well temperatures may exceed the desired set temperature. The device includes an alarm system that activates when this occurs.

The affected units were distributed to fertility clinics and laboratories in North Carolina, New Jersey, Texas, Virginia, Illinois, New York, California, and Pennsylvania.

The recalled product

Product: 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
Manufacturer: CooperSurgical, Inc.
Category: Medical Device — Reproductive Incubator
Hazard: temperature-exceedance
device-malfunction
Affected units: 22

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 (20)

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

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 →

Same manufacturer · CooperSurgical, Inc.

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