CooperSurgical, Inc. 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. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
CooperSurgical, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot Numbers 05593V291121 18-1192 1812-68 18-1268 G000575 G003811 G003893 G004517 G004874 G005109 G005476 G005723 E160415 Expiration date range: 27 Jun 2022 to 07 Dec 2024
CooperSurgical, Inc. is recalling Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (A due to There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential breach to the sterile barrier containing the Humidifier Bottles due to 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 may cause contamination and degradation or loss of embryo during incubation.
Recommended Action
Per FDA guidance
On August 12, 2022, the firm notified customers via an Urgent Medical Device Safety Notice. Customers were instructed to quarantine affected product in their inventory. Once customers complete and return the Acknowledgement and Receipt Form attached to the recall letter, the firm will arrange for the affected product to be returned at no cost. Customers will receive credit for returned affected product. CooperSurgical may be reached at 203-601-5200 ext. 03300 or recall@coopersurgical.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, CA, CT, DE, FL, GA, HI, IL, KS, MA, MI, MN, MO, NJ, NY, OH, OR, SC, TX, VT, VA, WA, WV, WI
Page updated: Jan 10, 2026