K-Systems G85 Mini Incubator May Exceed Desired Temperature
CooperSurgical recalls 37 K-Systems G85 Mini Incubators because the device warming surfaces may exceed the desired set temperature. The unit alarms when this occurs, but affected serial numbers require verification.
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 a risk-of-harm product—a critical reproductive medical device where precise temperature control is essential—but no adverse events or injuries have been reported. The FDA Class II classification reflects potential for harm without documented incidents.
Plain-English summary
CooperSurgical, Inc. has recalled 37 units of the K-Systems G85 Mini Incubator (Model K22074) due to a potential issue in which the warming surfaces or incubator well temperatures may exceed the desired set temperature. The device is an electrically-powered incubator designed to maintain closely regulated temperatures for reproductive biological materials such as gametes and embryos during assisted reproduction procedures.
The FDA has classified this as a Class II recall. According to the manufacturer, if temperatures exceed the desired set value, the device will alarm appropriately to alert the operator. However, the potential for temperature overshoot in this critical device presents a risk to the biological materials being incubated.
The recall affects 37 units distributed across eight U.S. states: North Carolina, New Jersey, Texas, Virginia, Illinois, New York, California, and Pennsylvania. Affected serial numbers include those ranging from 2244KH01 through 2321KH20. Users should verify their device serial number against the complete recall list to determine if their unit is affected.
Healthcare providers and patients using affected units should contact CooperSurgical, Inc. or check the FDA recall notice for specific guidance on addressing this issue.
The recalled product
- Product
- Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 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.
- 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: K22074
- Primary DI Number: 00888937025057
- Serial Numbers: 2244KH01
- 2244KH02
- 2244KH03
- 2244KH04
- 2244KH05
- 2244KH06
- 2244KH07
- 2244KH08
- 2244KH09
- 2244KH10
- 2313KH01
- 2313KH02
- 2313KH03
- 2313KH04
- 2313KH05
- 2313KH06
- 2313KH07
- 2313KH08
Distribution
Distributed in 14 states:
- CA
- DE
- ID
- IL
- IN
- MA
- MT
- NC
- NJ
- NY
- PA
- SD
- TX
- VA
Related recalls
Same category
- ModerateOneLIF Interbody Cage Inserter Attachment Failure Recall
FDA (Devices) · 2026-05-27
- ModerateMedtronic DLP Retrograde Cannula Model 94965 Sterile Barrier Breach
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 13FR Model 94913L Recall
FDA (Devices) · 2026-05-27