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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 1 of 12

Device	Model / Reference	Registries	Class	Status
Enteral Feeding	ENFCAPLD	FDA UDI	Class II	Active
Enteral Feeding	TL-INT-20	FDA UDI	Class II	Active
Enteral Feeding	ENFMEDCAPLD	FDA UDI	Class II	Active
Docking Station Adapter for canister 2 L	079.0038	FDA UDI	Class II	Active
PNSMX Resupply kits	101045232	FDA UDI	Class II	Active
Disposable tube 200cm	077.0963	FDA UDI	Class II	Active
Suction jar polysulfone 2l	077.0120	FDA UDI	Class II	Active
Silicone tubing	077.0970	FDA UDI	Class II	Active
Enteral Feeding	NGF-60	FDA UDI	Class II	Unknown
Enteral Feeding	NGF30	FDA UDI	Class II	Unknown
Vacuum tubing with coupling piece	077.0154	FDA UDI	Class II	Active
Enteral Feeding	ENPV1650	FDA UDI	Class II	Active
Enteral Feeding	ENFPV2665	FDA UDI	Class II	Unknown
Enteral Feeding	ENPU-20-65	FDA UDI	Class II	Active
Enteral Feeding	NGF30ST	FDA UDI	Class II	Unknown
Pump In Style	101041359	FDA UDI	Class II	Active
Enteral Feeding	ENFPU2040LD	FDA UDI	Class II	Active
Thopaz	Thopaz	FDA UDI	Class II	Unknown
Thopaz tubing double, small connector	079.0024	FDA UDI	Class II	Active
Enteral Feeding	NGF-10	FDA UDI	Class II	Unknown
Wall Adapter	077.0192	FDA UDI	Class II	Active
Large lid with conical patient connection 10–14 mm	077.0430	FDA UDI	Class II	Active
Enteral Feeding	ENPV-26-50	FDA UDI	Class II	Active
Invia Foam Dressing Kit	200.8907	FDA UDI	Class II	Active
Invia Liberty Tubing with quick connector	087.0025	FDA UDI	Class II	Active
Angle piece Orange DCS	077.0101	FDA UDI	Class II	Active
Enteral Feeding	ENFFEMALE	FDA UDI	Class II	Unknown
Invia Motion 15 Days	200.8589	FDA UDI	Class II	Active
Invia Drain Adapter	087.0024	FDA UDI	Class II	Active
Disposable bacteria filter	077.0574	FDA UDI	Class II	Active
Enteral Feeding	ENFMEDCAPNS	FDA UDI	Class II	Unknown
Thopaz+	Thopaz+	FDA UDI	Class II	Active
Pump In Style Advanced	Advanced Personal Double Starter Breast Pump	FDA UDI	Class II	Active
Silicone tubing	077.0902	FDA UDI	Class II	Active
Enteral Feeding	ENPV-36-50	FDA UDI	Class II	Active
Enteral Feeding	ENFMEDCAPNSLD	FDA UDI	Class II	Unknown
Plug for FMS lids	077.1023	FDA UDI	Class II	Active
Suction jar, 2 ltr	080.0024	FDA UDI	Class II	Active
Enteral Feeding	ENPU2080	FDA UDI	Class II	Active
Silicone tubing	077.0901	FDA UDI	Class II	Active
Enteral Feeding	INT-CAP	FDA UDI	Class II	Unknown
Enteral Feeding	NTL30	FDA UDI	Class II	Active
Symphony Breastmilk Initiation Kit-Sterile	67350S	FDA UDI	Class II	Active
Symphony Breast Milk Initiation Kit – Non Sterile	101041821	FDA UDI	Class II	Active
Trolley B for DCS	077.0190	FDA UDI	Class II	Active
Symphony & Harmony Double Duet Initiation Kit	67355S	FDA UDI	Class II	Active
Enteral Feeding	ENFPU1640	FDA UDI	Class II	Unknown
Enteral Feeding	7773	FDA UDI	Class II	Unknown
Enteral Feeding	ENFGF60	FDA UDI	Class II	Unknown
Enteral Feeding	ENF60	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.