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.
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 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.
- Affected units
- 5,182
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
Part of a larger recall action
This product is one of 2 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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