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.
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 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.
- 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
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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