Humidifier bottle and syringe filter kit — Class II medical device recall Z-1823-2022
Ongoing recall by CooperSurgical, Inc., reported 2022-10-05, distributed in AL, AZ, CA, CT, DE, FL, GA, HI…. There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of t
| Recall number | Z-1823-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2022-08-12 |
| Classified | 2022-09-28 |
| Reported by FDA | 2022-10-05 |
| Distributed | 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 |
| Countries outside the US | BB, CA, CL, PA |
| Quantity | 5,182 kits |
| Reason classes | sterility, specification failure |
| Lot numbers | 18-1265, 18-1268, G004637, G004638, G004639 |
Product
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1823-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.