K-Systems T47 Warming Plate May Exceed Set Temperatures
CooperSurgical recalls K-Systems T47 Warming Plates because temperature may exceed the desired set value, potentially affecting biological materials. The device alarms appropriately when this occurs.
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 with no reported illnesses or injuries. The hazard involves a potential temperature control defect in a medical device used for embryo and gamete incubation, representing a risk-of-harm product where injury has not yet been reported. The built-in alarm system provides mitigation but does not eliminate the underlying functional defect.
Plain-English summary
CooperSurgical, Inc. is recalling 35 K-Systems T47 Warming Plates (Model K23055) distributed across the United States. The T47 is an electrically powered incubation device designed to maintain precise, regulated temperatures for reproductive biological materials such as gametes and embryos during assisted reproduction procedures.
The FDA issued a Class II recall because the warming surfaces or incubator well temperatures of the affected units may exceed the desired set temperature. The device will alarm appropriately when this occurs. If temperatures rise above the desired set point, this could potentially affect the viability of biological materials being processed.
The affected units were distributed to assisted reproduction facilities in North Carolina, New Jersey, Texas, Virginia, Illinois, New York, California, and Pennsylvania. Specific serial numbers affected by this recall are listed on the FDA website.
Facilities using the affected models should verify their device serial numbers against the recall list and contact CooperSurgical for guidance on inspection, maintenance, or replacement.
The recalled product
- Product
- 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
- Manufacturer
- CooperSurgical, Inc.
- Category
- Medical Device
- Hazard
- temperature-overheat
- device-malfunction
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: 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
Distribution
Distributed in 14 states:
- CA
- DE
- ID
- IL
- IN
- MA
- MT
- NC
- NJ
- NY
- PA
- SD
- TX
- VA
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