K-Systems G73 Dry Bath Incubator may exceed target temperature
CooperSurgical is recalling K-Systems G73 Dry Bath Incubators because warming surfaces may exceed the desired set temperature. The device alarms 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 where temperature control may fail on a device intended for sensitive reproductive biological materials. No injuries or illnesses have been reported, and the device includes alarm functionality. The score reflects the risk-of-harm nature of the defect per the rubric for products where injury has not yet been reported.
Plain-English summary
CooperSurgical is recalling 106 units of the K-Systems G73 Dry Bath Incubator (Model K22065) due to a temperature control issue.
The warming surfaces or incubator well temperatures of affected units may exceed the desired set temperature. When temperatures exceed the set value, the device will activate an alarm to alert the operator.
This recall affects units distributed in eight US states: North Carolina, New Jersey, Texas, Virginia, Illinois, New York, California, and Pennsylvania. International customers should note that many countries classify these devices as laboratory equipment rather than medical devices.
If you own one of the affected units, monitor the device's temperature display and alarm notifications during use. Contact CooperSurgical directly for further instructions.
The recalled product
- Product
- Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 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 c
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- temperature-overshoot
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: K22065
- Primary DI Number: 00888937025040
- Serial Numbers: 2202KH46
- 2202KH47
- 2202KH48
- 2202KH49
- 2202KH50
- 2202KH51
- 2202KH52
- 2202KH53
- 2202KH54
- 2202KH55
- 2208KH01
- 2208KH02
- 2208KH03
- 2208KH04
- 2208KH05
- 2208KH06
- 2208KH07
- 2208KH08
Distribution
Distributed in 14 states:
- CA
- DE
- ID
- IL
- IN
- MA
- MT
- NC
- NJ
- NY
- PA
- SD
- TX
- VA
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