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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 8 of 12

Device	Model / Reference	Registries	Class	Status
Disposable overflow protection / bacteria filter	077.0571	FDA UDI	Class II	Active
Disposable Overflow Protection / Bacteria Odour Filter	101035285	FDA UDI	Class II	Active
Enteral Feeding	ENFPV1680	FDA UDI	Class II	Unknown
Invia Motion 60 Days NPWT	200.8591	FDA UDI	Class II	Active
Filter paper for autoclavable bacteria filter	077.1014	FDA UDI	Class II	Active
Enteral Feeding	ENPV2650	FDA UDI	Class II	Active
Filter, particle, Medela connection	077.0582	FDA UDI	Class II	Active
Disposable virus filter	101035284	FDA UDI	Class II	Active
Y-piece	077.1020	FDA UDI	Class II	Active
Disposable overflow protection /bacteria/odour filter	077.0092	FDA UDI	Class II	Active
KV-6 Suction Pump	200.5625	FDA UDI	Class II	Active
Safety Set for railholder	077.0651	FDA UDI	Class II	Active
Enteral Feeding	TLINT20	FDA UDI	Class II	Unknown
Standard rail universal holder	079.0040	FDA UDI	Class II	Active
PersonalFit Flex Connector	101038233	FDA UDI	Class II	Active
Coupling piece	077.1018	EUDAMEDFDA UDI	Class II	Active
18mm PersonalFit™ Plus Breast shields	101046457	FDA UDI	Class II	Active
Enteral Feeding	ENF060192	FDA UDI	Class II	Unknown
Holder with standard rail	079.0036	FDA UDI	Class II	Active
Apgar-Timer	017.0015	FDA UDI	Class I	Active
Change over valve	077.0561	FDA UDI	Class II	Active
Specimen Cup	077.0094	FDA UDI	Class II	Active
PNSMX Resupply kits	101045230	FDA UDI	Class II	Active
Enteral Feeding	NTL-05	FDA UDI	Class II	Active
Enteral Feeding	ENF001	FDA UDI	Class II	Unknown
Silicone tubing	077.0931	FDA UDI	Class II	Active
Enteral Feeding	ENFPU1650	FDA UDI	Class II	Unknown
Enteral Feeding	TL-060-19	FDA UDI	Class II	Active
Invia Liberty canister 0.8l	087.0017	FDA UDI	Class II	Active
Pump In Style® Pro Bundle	101047718	FDA UDI	Class II	Active
Swing Maxi	101043614	FDA UDI	Class II	Active
Enteral Feeding	INT-05	FDA UDI	Class II	Active
Small lid with conical patient connection and overflow protection device	077.0440	FDA UDI	Class II	Active
Enteral Feeding	TL-INT-60	FDA UDI	Class II	Active
Enteral Feeding	ENFPU2050LD	FDA UDI	Class II	Active
Resupply Kit Swing Maxi/Freestyle Hands-free Pump	101047292	FDA UDI	Class II	Active
Disposable virus / odour filter	101035288	FDA UDI	Class II	Active
Enteral Feeding	ENFPV2680LD	FDA UDI	Class II	Active
Quiver 280mm	077.0531	FDA UDI	Class II	Active
Enteral Feeding	ENFPV2680	FDA UDI	Class II	Unknown
Trolley A for DCS	077.0188	FDA UDI	Class II	Active
Duo Hands-free	101045670	FDA UDI	Class II	Active
Angle piece yellow DCS	077.0100	FDA UDI	Class II	Active
Double set 2l	077.0707	FDA UDI	Class II	Active
Enteral Feeding	ENPU-20-50	FDA UDI	Class II	Active
Enteral Feeding	ENFDUALCAPNS	FDA UDI	Class II	Unknown
Enteral Feeding	NGF60ST	FDA UDI	Class II	Unknown
Enteral Feeding	ENFPU1680	FDA UDI	Class II	Unknown
Enteral Feeding	INT03	FDA UDI	Class II	Active
Enteral Feeding	INT-60	FDA UDI	Class II	Active

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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.