CooperSurgical recalls humidifier bottles and syringe filter kits for BT37 Mark II incubators due to potential sterile barrier breaches causing embryo contamination. Affected units include specific lot numbers.
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.
CooperSurgical is recalling humidifier bottles and syringe filter kits for their BT37 Mark II Benchtop Incubators. The recall is because the packaging might damage the sterile barrier, risking embryo contamination during incubation.
The filter kit packaging inside the humidifier bottle could breach the sterile barrier. This might lead to using unsterilized devices, causing embryo contamination or loss during incubation.
Benchtop incubator users who own the BT37 Mark II model with specific lot numbers. Those handling embryos in research or medical settings are most at risk.
Check for lot numbers 18-1265, 18-1268, or G004637-G004639 on the humidifier bottles and syringe filter kits. These items are for the BT37 Mark II Benchtop Incubator.
Look for lot numbers 18-1265, 18-1268, or G004637-G004639 on the humidifier bottles and syringe filter kits.
The packaging of the filter box inside the humidifier bottle may breach the sterile barrier, risking embryo contamination during incubation.
The official recall notice does not specify a remedy or action steps beyond checking the lot numbers.
The recall addresses a potential risk of embryo contamination due to sterile barrier breaches, but the hazard level is low risk as the remedy focuses on checking lot numbers without immediate action.
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1823-2022 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-1823-2022 from CooperSurgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
