CooperSurgical incubator humidifier kit recall due to sterile barrier breach
CooperSurgical is recalling 5,182 humidifier bottle and filter kits for BT37 Mark II incubators due to potential sterile barrier damage from packaging defects. This could result in use of unsterilized components, risking embryo contamination.
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 medical device recall involving a sterile barrier breach in laboratory equipment. Although no illnesses or injuries have been reported, this represents a risk-of-harm scenario where potential contamination could result in embryo loss during incubation.
Plain-English summary
CooperSurgical, Inc. is recalling 5,182 humidifier bottle and syringe filter kits (6 of each per kit) for the BT37 Mark II Benchtop Incubator, identified by lot numbers 18-1265, 18-1268, G004637, G004638, and G004639.
The humidifier bottles in these kits have a potential breach to the sterile barrier. The breach is caused by the packaging of the filter box located inside the bottle packaging. Damage to the sterile barrier may result in use of an unsterilized device, which could cause contamination and loss of embryos during incubation.
The kits were distributed domestically to Alabama, Arizona, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Kansas, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New York, Ohio, Oregon, South Carolina, Texas, Virginia, Vermont, Washington, Wisconsin, and West Virginia. International distribution included Barbados, Canada, Chile, Micronesia, and Panama. Facilities that have received affected kits should not use them.
The recalled product
- Product
- Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- sterility-breach
- contamination
- embryo-loss
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 (1)
- Lot Numbers 18-1265 18-1268 18-1268 / G004639 G004637 G004638 G004639
Distribution
Distributed in 25 states:
- AL
- AZ
- CA
- CT
- DE
- FL
- GA
- HI
- IL
- KS
- MA
- MI
- MN
- MO
- NJ
- NY
- OH
- OR
- SC
- TX
- VA
- VT
- WA
- WI
- WV
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03