Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Humidifier bottle and syringe filter kit (6 count of each) Recalled by CooperSurgical, Inc. Due to There is a potential breach to the sterile...

Date: August 12, 2022
Company: CooperSurgical, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact CooperSurgical, Inc. directly.

Affected Products

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

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 25 states: AL, AZ, CA, CT, DE, FL, GA, HI, IL, KS, MA, MI, MN, MO, NJ, NY, OH, OR, SC, TX, VT, VA, WA, WV, WI

Affected (25 states)Not affected

About CooperSurgical, Inc.

CooperSurgical, Inc. has 83 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report