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Pump, Breast, Powered

FDA product code HGX · Class 2 · Obstetrics/Gynecology

1,103
Registered devices
5,568
Adverse events
8
Recalls
253
510(k) clearances

Devices with this code

Motif Medical — CIMILRE CO .,LTDPump In Style® Hands-free — Medela LLCSpectra — UZINMEDICARE CO.,LTDSymmetrical Health, LLC — CIMILRE CO .,LTDMILKDROP PTY LTD — CIMILRE CO .,LTDSpectra — UZINMEDICARE CO.,LTDMotif Medical — CIMILRE CO .,LTDLansinoh — LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SANAYI TICARET LTD STIYouha Powered breast pump — Ningbo Youhe Mother And Baby Products Co., Ltd.Paruu — Linhejiacheng (Shenzhen) E-commerce Co., Ltd.Ameda, Inc. — AMEDA, INC.Pump In Style® Pro — Medela LLCDouble Pumping Collection Kit — Ardo medical AGFreemie — DAO HEALTHParuu — Zhejiang Carebao Co., Ltd.Philips Avent Double electric breast pump Advanced — Philips Consumer Lifestyle B.V.ViveCare — VIVE HEALTH LLCHaenim — Haenim Co.,Ltd.ViveCare — VIVE HEALTH LLCReplacement 24mm Flange 2.0 — WILLOW INNOVATIONS, INC.Philips Avent Single Electric Breast Pump — Philips Consumer Lifestyle B.V.Motif Medical — CIMILRE CO .,LTDSpectra — UZINMEDICARE CO.,LTDdrive — Drive Devilbiss Healthcare

Recent recalls

DateFirmReason
2017-07-10AMEDA, INC.Two specific lots was incorrectly manufactured containing a UK power adapter.
2014-03-18Energizer Personal CareSome of the power adapters outer casings may become loose and separate, resulting in a potential for electric shock.
2011-01-10Medela IncThe performance of the pumps may be compromised due to the potentiometer used on the circuit board. Affected pumps may not turn on, may turn off on its own, ma
2010-08-06Medela IncThe product sterility may be compromised due to possible pinholes in the rigid tray of the package.
2010-08-06Medela IncThe product sterility may be compromised due to possible pinholes in the rigid tray of the package.
2010-08-06Medela IncThe product sterility may be compromised due to possible pinholes in the rigid tray of the package.
2010-08-06Medela IncThe product sterility may be compromised due to possible pinholes in the rigid tray of the package.
2010-03-15Medela IncThe non-sterile devices were erroneously packaged with instructions stating the devices are sterile and do not require cleaning before first use.

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