FDA Medical Device Recalls (openFDA)
CooperSurgical, Inc.: Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
- Recall number
- Z-1823-2022
- Recalling firm
- CooperSurgical, Inc.
- Product
- Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
- Status
- Open, Classified
- Initiated
- 2022-08-12
- Posted
- 2022-09-28
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 5,182 kits
- Distribution
- Domestic distribution to the following 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 Foreign distribution to Barbados, Canada, Chile, Micronesia Federate, and Panama.
- Lot, serial or model codes
- Lot Numbers 18-1265 18-1268 18-1268 / G004639 G004637 G004638 G004639
- 510(k) numbers
- ["K121566"]
- PMA numbers
- not on file
- Product code
- MQG
- Firm FEI
- 1216677
- Firm city
- Trumbull
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28