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Accessory, Assisted Reproduction

FDA product code MQG · Class 2 · Obstetrics/Gynecology

95
Registered devices
11
Adverse events
9
Recalls
46
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2023-12-07Cook Medical LlcThe MINC+ device is susceptible to losing temperature control of electrostatic discharge (static electricity) is applied to the lid of the device. This may lead
2022-08-12CooperSurgical, Inc.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.
2022-08-12CooperSurgical, Inc.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.
2020-12-16Cook Medical LlcA small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause the silicone stoppers to dislodge or gas to leak from
2019-09-05CooperSurgical, Inc.The touchpad may not work properly after cleaning.
2018-03-22Cook Inc.Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or elect
2018-03-22Cook Inc.Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or elect
2018-01-12Cook Inc.The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failur
2018-01-12Cook Inc.The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failur

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.