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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 10 of 12

Device	Model / Reference	Registries	Class	Status
Invia Motion Endure	200.8587	FDA UDI	Class II	Active
Pump in Style Advanced	PNSA Starter Pump	FDA UDI	Class II	Unknown
Enteral Feeding	ENF30	FDA UDI	Class II	Active
Enteral Feeding	LID-10	FDA UDI	Class II	Active
Enteral Feeding	ENPV3665	FDA UDI	Class II	Active
Enteral Feeding	TLINT03	FDA UDI	Class II	Unknown
Freestyle	Freestyle Solution Set	FDA UDI	Class II	Active
Enteral Feeding	PLG30	FDA UDI	Class II	Active
Enteral Feeding	ENF060182	FDA UDI	Class II	Unknown
Docking Station	079.0037	FDA UDI	Class II	Active
Vario Filter set, bacteria & overflow	077.0834	FDA UDI	Class II	Active
Symphony & Harmony Double Duet Breastpump kit	67114S	FDA UDI	Class II	Active
KV-6 Safety Set Jar 0.25 ltr	080.0014	FDA UDI	Class II	Active
Invia Foam Dressing Kit	200.8906	FDA UDI	Class II	Active
Enteral Feeding	ENFGF10	FDA UDI	Class II	Unknown
Angle piece	077.1016	FDA UDI	Class II	Active
Enteral Feeding	ENF06018	FDA UDI	Class II	Unknown
Pump In Style	101041361	FDA UDI	Class II	Active
Enteral Feeding	PLG-60	FDA UDI	Class II	Active
Enteral Feeding	ENPV-16-50C	FDA UDI	Class II	Active
KV-6 Suction Pump	200.5625	FDA UDI	Class II	Active
Single set 1l, clampholder	077.0701	FDA UDI	Class II	Active
Symphony & Harmony Double Duet Breast pump kit-Sterile	67115S	FDA UDI	Class II	Active
Quiver 480mm	077.0532	FDA UDI	Class II	Active
Suction jar polysulfone 0.25l	077.0125	FDA UDI	Class II	Active
Enteral Feeding	7772	FDA UDI	Class II	Unknown
Enteral Feeding	NTL05	FDA UDI	Class II	Active
Enteral Feeding	ENPU-16-50	FDA UDI	Class II	Active
Invia Gauze Dressing Kit	200.8909	FDA UDI	Class II	Active
Enteral Feeding	NGW2000	FDA UDI	Class II	Active
Enteral Feeding	ENPU-20-40	FDA UDI	Class II	Active
Enteral Feeding	INT-10	FDA UDI	Class II	Active
Enteral Feeding	EB06015	FDA UDI	Class II	Active
Enteral Feeding	ENFPV4280LD	FDA UDI	Class II	Active
Resupply Kit Swing Maxi/Freestyle Hands-free Pump	101047294	FDA UDI	Class II	Active
Invia Motion 15 Days Kit 10 x 10 cm	101045891	FDA UDI	Class II	Active
Enteral Feeding	ENFPV3665LD	FDA UDI	Class II	Active
Solo™	101041624	FDA UDI	Class II	Active
Hands-free Breast shields, 21mm	101045781	FDA UDI	Class II	Active
Enteral Feeding	ENF003	FDA UDI	Class II	Unknown
Vario 18 AC	026.0006	FDA UDI	Class II	Active
Enteral Feeding	TL-060-18	FDA UDI	Class II	Active
Single set 2l	077.0716	FDA UDI	Class II	Active
Silicone tube, ID 7mm, 33cm	077.0911	FDA UDI	Class II	Active
Y-piece 7 mm Disposable System	077.0098	FDA UDI	Class II	Active
Dominant Flex rack	Dominant Flex	FDA UDI	Class II	Active
Enteral Feeding	NTL60	FDA UDI	Class II	Active
Enteral Feeding	EB06014	FDA UDI	Class II	Unknown
Disposable Overflow Protection / Virus Filter	101035264	FDA UDI	Class II	Active
Enteral Feeding	NGF-30ST	FDA UDI	Class II	Unknown

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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.