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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 9 of 12

Device	Model / Reference	Registries	Class	Status
Symphony & Lactina Breastpump kit- Sterile	67316S	FDA UDI	Class II	Active
Swing Breast Pump	67050	FDA UDI	Class II	Unknown
Enteral Feeding	INT20	FDA UDI	Class II	Unknown
Enteral Feeding	ENPU3650	FDA UDI	Class II	Active
Enteral Feeding	ENPV-36-65	FDA UDI	Class II	Active
Serial connection vacuum	077.0095	FDA UDI	Class II	Active
18mm PersonalFit™ Plus Breast shields	101046456	FDA UDI	Class II	Active
Hands-free Membranes	101045784	FDA UDI	Class II	Active
Enteral Feeding	TL-070-19	FDA UDI	Class II	Active
Invia Motion 15 Days NPWT	200.8589	FDA UDI	Class II	Active
Pump In Style Advanced	Advanced Personal Double Breast Pump	FDA UDI	Class II	Unknown
Sonata Breastpump	Sonata Deluxe	FDA UDI	Class II	Active
PNSMX Resupply kits	101046458	FDA UDI	Class II	Active
Enteral Feeding	TL-004	FDA UDI	Class II	Active
Enteral Feeding	TL060192	FDA UDI	Class II	Active
Enteral Feeding	ENF06019	FDA UDI	Class II	Unknown
Enteral Feeding	INTCAP	FDA UDI	Class II	Unknown
Trolley for Basic and Dominant Flex	071.0034	FDA UDI	Class II	Active
Basic	101046565	FDA UDI	Class II	Active
Enteral Feeding	ENFPU2080	FDA UDI	Class II	Unknown
Adapter Vario	077.0105	FDA UDI	Class II	Active
Pump In Style® Hands-free	101045436	FDA UDI	Class II	Active
Enteral Feeding	TLCAP	FDA UDI	Class II	Active
Enteral Feeding	TL07018	FDA UDI	Class II	Active
Dominant Flex	101046566	FDA UDI	Class II	Active
Enteral Feeding	ENPU2065	FDA UDI	Class II	Active
Enteral Feeding	EB-060-19	FDA UDI	Class II	Active
Invia Abdominal Dressing Kit	087.6250	FDA UDI	Class II	Active
Enteral Feeding	TL001	FDA UDI	Class II	Active
Suction jar polysulfone 3l	077.0130	FDA UDI	Class II	Active
Enteral Feeding	NGW1000	FDA UDI	Class II	Active
Symphony Breast Pump Kit	101040420	FDA UDI	Class II	Active
Enteral Feeding	ENFFEMALELD	FDA UDI	Class II	Active
Enteral Feeding	ENFPU3650LD	FDA UDI	Class II	Active
Enteral Feeding	ENPU3665	FDA UDI	Class II	Active
Thopaz disposable canister 2l	079.0018	FDA UDI	Class II	Active
Enteral Feeding	ENPU1665	FDA UDI	Class II	Active
Enteral Feeding	NGW1000M	FDA UDI	Class II	Unknown
Basic	101046564	FDA UDI	Class II	Active
Enteral Feeding	ENPU-42-100	FDA UDI	Class II	Active
Enteral Feeding	TL-INT-03	FDA UDI	Class II	Active
Enteral Feeding	ENFPU3665	FDA UDI	Class II	Unknown
Enteral Feeding	ENPV-16-50	FDA UDI	Class II	Active
Pump In Style Advanced	Advanced Personal Double Breast Pump with Batt	FDA UDI	Class II	Unknown
Pump In Style® Pro	101047093	FDA UDI	Class II	Active
Invia Integrated Dressing	101035697	FDA UDI	Class II	Active
Symphony & Lactina Breastmilk Initiation Kit- Sterile	67340S	FDA UDI	Class II	Active
Enteral Feeding	ENF07018	FDA UDI	Class II	Unknown
Enteral Feeding	EB-060-192	FDA UDI	Class II	Active
Enteral Feeding	ENF060192LD	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.