Z-1822-2022Class II

Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295)...

Name: Z-1822-2022 Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295)...
Creator: CooperSurgical, Inc.
Published: 2022-08-12
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2022-08-12 / Open, Classified / root cause: packaging

FDA source

CooperSurgical, Inc. began a recall of 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... on 2022-08-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1822-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-12
Posted: 2022-09-28
Recalling firm: CooperSurgical, Inc.
Product: 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.
Product code: MQG Accessory, Assisted Reproduction
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.
Root cause tag: packaging
FDA 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 [email protected].
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1822-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1822-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28
Z-1823-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-28

Product code MQG

K121566Class IIPlaner Bt37 IncubatorPlaner Plc / cleared 2012-11-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)