K-Systems R65 embryo incubator temperature may exceed setpoint
CooperSurgical's K-Systems R65 Trolley reproductive incubators may experience temperature excursions above desired setpoints, though devices will alarm when this occurs. The FDA issued a Class II recall of 43 units across eight U.S. states.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported injuries, illnesses, or harm. The device includes a functioning alarm safeguard to notify users when temperatures exceed desired setpoints, and no actual incidents are documented.
Plain-English summary
CooperSurgical is recalling the K-Systems R65 Trolley incubator (Model K24012), an electrically-powered device intended to provide warming and incubation conditions for reproductive biological materials, such as gametes and embryos, during assisted reproduction procedures.
The warming surfaces or incubator well temperatures of the recalled devices may exceed the desired set temperature. When this occurs, the device will alarm appropriately.
Forty-three units have been distributed to facilities in North Carolina, New Jersey, Texas, Virginia, Illinois, New York, California, and Pennsylvania. This is classified as an FDA Class II recall.
If you have one of the affected devices, contact CooperSurgical, Inc. for information regarding this recall.
The recalled product
- Product
- 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…
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 43
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: 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
Distribution
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.
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