Recall

Class II — CooperSurgical, Inc.

Recalling firm	COOPERSURGICAL, INC.
Registered facility	View this company's 6 registered facilities → (openFDA recall records do not name a specific facility)
Classification	Class II
Status	Ongoing
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.
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.
Quantity	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.
Initiated	2022-08-12
Classified	2022-09-28
Recall number	Z-1822-2022
Initiation	Voluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — CooperSurgical, Inc. (Z-1822-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90782/

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