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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 5 of 12

Device	Model / Reference	Registries	Class	Status
Enteral Feeding	TL-003	FDA UDI	Class II	Active
Enteral Feeding	TLINT05	FDA UDI	Class II	Unknown
Enteral Feeding	INT-20	FDA UDI	Class II	Active
Enteral Feeding	ENFPU1650LD	FDA UDI	Class II	Active
Enteral Feeding	ENFPU42100LD	FDA UDI	Class II	Active
Double set 5l	077.0706	FDA UDI	Class II	Active
Enteral Feeding	ENF060182LD	FDA UDI	Class II	Active
PNSMX Resupply kits	101045231	FDA UDI	Class II	Active
Enteral Feeding	101034137	FDA UDI	Class II	Active
Enteral Feeding	TL060182	FDA UDI	Class II	Active
Enteral Feeding	TL-001	FDA UDI	Class II	Active
Enteral Feeding	TL002	FDA UDI	Class II	Active
KV-6 Safety Set Lid	080.0015	FDA UDI	Class II	Active
Enteral Feeding	ENFPU2065LD	FDA UDI	Class II	Active
Vario 18 AC	Vario 18 AC	FDA UDI	Class II	Active
Enteral Feeding	ENFPV3650LD	FDA UDI	Class II	Active
Invia Fitpad	200.7943	FDA UDI	Class II	Active
Enteral Feeding	ENFPV2650	FDA UDI	Class II	Unknown
Invia Liberty	Liberty	FDA UDI	Class II	Active
Thopaz tubing double, large connector	079.0026	FDA UDI	Class II	Active
Enteral Feeding	ENFPV2650LD	FDA UDI	Class II	Active
Invia Motion 60 Days Bundle	101045408	FDA UDI	Class II	Active
Enteral Feeding	TL-060-182	FDA UDI	Class II	Active
Freestyle Breastpump	67065	FDA UDI	Class II	Active
Lactina Double Breast pump kit WIC	6107170W	FDA UDI	Class II	Active
Enteral Feeding	EB06019	FDA UDI	Class II	Active
Enteral Feeding	ENPU4280	FDA UDI	Class II	Active
Change-over valve with clampholder and tubing set	077.0563	FDA UDI	Class II	Active
Suction Bag 1.5l	077.0083	FDA UDI	Class II	Active
Thopaz	Thopaz	FDA UDI	Class II	Unknown
Enteral Feeding	ENF06018LD	FDA UDI	Class II	Active
Wall bracket, single	077.0523	FDA UDI	Class II	Active
Enteral Feeding	ENFPU1665	FDA UDI	Class II	Unknown
Symphony and Lactina Breastpump kit -WIC	67116W	FDA UDI	Class II	Active
Enteral Feeding	TL003	FDA UDI	Class II	Active
Enteral Feeding	ENPV2680	FDA UDI	Class II	Active
Enteral Feeding	ENFPU3665LD	FDA UDI	Class II	Active
Enteral Feeding	ENFCAP	FDA UDI	Class II	Unknown
PersonalFit Flex™ Double Pumping Kit	101045851	FDA UDI	Class II	Active
Hands-free Breast shields, 24mm	101045782	FDA UDI	Class II	Active
Invia White Foam NPWT	087.6303	FDA UDI	Class II	Active
Swing Maxi	101043638	FDA UDI	Class II	Active
Freestyle Flex Tubing	101038234	FDA UDI	Class II	Active
Disposable bacteria / odour filter	077.0575	FDA UDI	Class II	Active
Silicone tubing	077.0905	FDA UDI	Class II	Active
Pump In Style Advanced	PNSA Starter Pump	FDA UDI	Class II	Unknown
Invia Liberty	Liberty	FDA UDI	Class II	Active
Enteral Feeding	EB-060-182	FDA UDI	Class II	Active
Disposable bacteria filter	077.0573	FDA UDI	Class II	Active
Silicone tubing	077.0900	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.