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Medela LLC

Last updated September 17, 2026

Information

Country: US
Address: 1101 CORPORATE DR., MCHENRY, IL, 60050
Website: medela.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1-800-435-8316
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1419937
DUNS Number: 052002029

Catalogue (579)

Page 12 of 12

Device	Model / Reference	Registries	Class	Status
Medela Pump In Style Advanced Breast Pump	K031614	FDA 510(k)	Class II	Active
Phototherapy Lamp	K984589	FDA 510(k)	Class II	Active
Invia White Foam NPWT	K180415	FDA 510(k)	Class II	Active
Medela Dominant 35 C/I Secretion And Surgical Aspirator	K043544	FDA 510(k)	Class II	Active
Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty	K150499	FDA 510(k)	Class II	Active
Invia Motion Negative Pressure Wound Therapy System	K113678	FDA 510(k)	Class II	Active
Medela Thopaz+	K141553	FDA 510(k)	Class II	Active
Medela's Foot Pump	K952034	FDA 510(k)	Class I	Active
Medela Single Use Silc Cup, Model 077.0791	K041579	FDA 510(k)	Class II	Active
Pump In Style Advanced, Advanced Personal Double Breastpump	K181937	FDA 510(k)	Class II	Active
Bilibed Phototherapy Lamp	K962612	FDA 510(k)	Class II	Active
Freestyle Mini Hands-free	K253510	FDA 510(k)	Class II	Active
Medela Suction Pump	K830012	FDA 510(k)	Class II	Active
Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film	K170088	FDA 510(k)	Class II	Active
Freestyle Flex	K191653	FDA 510(k)	Class II	Active
Vario 8/18/ci	K153663	FDA 510(k)	Class II	Active
Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental	K151632	FDA 510(k)	Class II	Active
Magic InBra	K251377	FDA 510(k)	Class II	Active
Ab Vacuum Extractor Silc-Cup	K841492	FDA 510(k)	Class II	Active
Pump In Style	K200508	FDA 510(k)	Class II	Active
Motion InBra (YM-8801) wearable breast pump	K253149	FDA 510(k)	Class II	Active
Medela Clario Home Care Pump	K033179	FDA 510(k)	Class II	Active
Medela Namual Breast Pump	K823840	FDA 510(k)	Class I	Active
Cannon Babysafe Nipple Shields	K853176	FDA 510(k)	Class I	Active
Invia® Integrated Dressing	K223388	FDA 510(k)	Class II	Active
Supplemental Feeding System	K844297	FDA 510(k)	Class I	Active
Invia Abdominal Dressing Kit	K182191	FDA 510(k)	Class II	Active
Medela Dominant 50 Lipo, Model 600-5706	K063336	FDA 510(k)	Class II	Active
Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters	K142626	FDA 510(k)	Class II	Active

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Authorities

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FDA Recalls (12)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 2, 2019	Z-0773-2020	—	terminated	Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.
Dec 5, 2018	Z-2061-2019	—	terminated	The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact.
Feb 7, 2018	Z-2528-2018	—	terminated	Device may display a battery missing error.
Jul 27, 2011	Z-3172-2011	—	terminated	Medela determined that some of the individual kits or bags of lot #370118 of "0877061 Wound Dressing Set, Tier I, 10 MM Flat Drain", were labeled incorrectly as "0877067 Wound Dressing Set, Tier III 15 Fr Round Channel Drain". The outside label on the case is correctly labeled as "0877061 Wound Dressing Set, Tier 1,10 MM Flat Drain".
May 18, 2011	Z-2553-2011	—	terminated	The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
Apr 4, 2011	Z-2386-2011	—	terminated	The power adaptor (transformer) used with the Pump In Style Advanced family of breast pumps have power cords that may easily become damaged if not properly handled.
Jan 10, 2011	Z-1224-2011	—	terminated	The 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, may reduce or lose suction during the pumping process, or may make a clicking noise.
Aug 6, 2010	Z-2483-2010	—	terminated	The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
Aug 6, 2010	Z-2484-2010	—	terminated	The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
Aug 6, 2010	Z-2486-2010	—	terminated	The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
Aug 6, 2010	Z-2485-2010	—	terminated	The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
Mar 15, 2010	Z-1442-2010	—	terminated	The non-sterile devices were erroneously packaged with instructions stating the devices are sterile and do not require cleaning before first use.