Humidifier Bottle and Syringe Filter Kit Sterile Barrier Breach Recall
CooperSurgical is recalling BT37 benchtop incubator humidifier and filter kits due to a potential sterile barrier breach. The defect may allow unsterilized devices to contaminate and degrade embryos during incubation.
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: FDA Class II recall involving potential sterile barrier breach in medical equipment used in embryo incubation. While the contamination risk is significant, no illnesses, injuries, or deaths have been reported. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
CooperSurgical is recalling humidifier bottle and syringe filter kits (6 count of each) designed for the BT37 Mark I Benchtop Incubator. The design can also be used with the BT37 Mark II Benchtop Incubator. A total of 5,182 kits have been distributed.
The recall is due to a potential breach in the sterile barrier of the humidifier bottles. The breach results from how the filter box is packaged inside the bottle packaging. This packaging defect can compromise the sterile barrier.
Damage to the sterile barrier may result in use of an unsterilized device, which may cause contamination and degradation or loss of embryos during incubation. No illnesses or injuries have been reported in connection with this recall.
The affected kits were distributed domestically across 30 U.S. states and internationally to Barbados, Canada, Chile, Micronesia, and Panama. The recall affects lot numbers 05593V291121, 18-1192, 1812-68, 18-1268, G000575, G003811, G003893, G004517, G004874, G005109, G005476, G005723, and E160415, with expiration dates ranging from June 27, 2022 to December 7, 2024.
The recalled product
- Product
- Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark I model is no longer produced, but the legacy humidifier bottle component design can also be used with the BT37 Mark II Benchtop Incubator.
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 5,182
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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