Lower riskMedical device recall · FDA · Published August 12, 2022
CooperSurgical Humidifier Bottles Risk: Sterile Barrier Breach in BT37 Mark II Incubator
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.
Take action
Contact the company
📍Recalling firmCooperSurgical, Inc.95 Corporate Dr · Trumbull, CT 06611-1350
“CooperSurgical Humidifier Bottles Risk: Sterile Barrier Breach in BT37 Mark II Incubator.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60172-coopersurgical-humidifier-bottles-risk-sterile-barrier-breach-in-bt37-mark. Based on FDA recall #Z-1823-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1823-2022%22&limit=1).
CooperSurgical, Inc. recalled Humidifier bottle and syringe filter kits for the BT37 Mark II Benchtop Incubator due to a potential sterile barrier breach that may cause contamination, according to the FDA on August 12, 2022.
How to tell if you have it
Brand: CooperSurgical
Product: Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
Lot Numbers: 18-1265, 18-1268, G004639, G004637, G004638, G004639
Units affected: 5,182 kits
The hazard
The packaging of the filter box located inside the bottle packaging may cause a potential breach to the sterile barrier containing the Humidifier Bottles. 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.
Context
GovInfoNow's records show CooperSurgical, Inc. has 37 other recalls on record since October 6, 2017. Recent brand recalls include a Neonatal CPAP Replacement Set recalled on August 11, 2026, for loose tubing and an HSG Procedure Tray recalled on June 11, 2025, for non-sterile iodine pouches mislabeled as sterile. Other recent recalls of similar products include Medline Convenience Kits (June 12, 2026), Boston Scientific EndoVive Safety PEG Kit (February 10, 2026), and Medline C-Section Prep Kits (June 12, 2026).
How to tell if you have this one
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.
Brand
CooperSurgical
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
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.
Recall number
Product, codes & lots
Z-1822-2022
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.; 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
Z-1823-2022
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246); Lot Numbers 18-1265 18-1268 18-1268 / G004639 G004637 G004638 G004639
Based on the official FDA remedy
What to do — step by step
Check Product Lot Numbers
Look for lot numbers 18-1265, 18-1268, or G004637-G004639 on the humidifier bottles and syringe filter kits.
Where it went and when
Where it was distributed
Distributed in 25 states, and outside the U.S.
Listed by the agency
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Kansas, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New York, Ohio, Oregon, South Carolina, Texas, Vermont, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 54 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
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.
Official source: FDA Recall #Z-1823-2022 (August 12, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1823-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.