FDA Device recall Z-1823-2022
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
- FDA Device
- Class II
- ongoing
- Published 2022-10-05
On 2022-10-05 the FDA classified a Class II recall of Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246) by Coopersurgical, citing 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 ster….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1823-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-12 |
| Published | 2022-10-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Coopersurgical |
| Distribution | 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 |
Product
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
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.
Identifiers
| code_info | Lot Numbers 18-1265 18-1268 18-1268 / G004639 G004637 G004638 G004639 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1823-2022%22
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