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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 7 of 12

Device	Model / Reference	Registries	Class	Status
Enteral Feeding	TL06019	FDA UDI	Class II	Active
Enteral Feeding	ENPU1640	FDA UDI	Class II	Unknown
Symphony Double Pumping Kit	67099	FDA UDI	Class II	Active
Pump In Style Advanced	Pump In Style Advance backpack	FDA UDI	Class II	Unknown
Thopaz+	Thopaz+	FDA UDI	Class II	Active
Enteral Feeding	LID60	FDA UDI	Class II	Active
Enteral Feeding	INT05	FDA UDI	Class II	Unknown
Invia Motion Endure	Invia Motion	FDA UDI	Class II	Unknown
Enteral Feeding	TL-060-192	FDA UDI	Class II	Active
Hands-free Collection Cups	101045671	FDA UDI	Class II	Active
Enteral Feeding	ENFPV1665	FDA UDI	Class II	Unknown
Symphony & Lactina Breast pump kit	67206	FDA UDI	Class II	Active
Disposable bacteria /odour filter	077.0576	FDA UDI	Class II	Active
Serial connection, patient	077.0158	FDA UDI	Class II	Active
Thopaz tubing double	079.0022	FDA UDI	Class II	Active
Enteral Feeding	ENFPU2065	FDA UDI	Class II	Unknown
Enteral Feeding	ENPU-20-80	FDA UDI	Class II	Active
Enteral Feeding	INT-30	FDA UDI	Class II	Active
Disposable Tubing	077.0965	FDA UDI	Class II	Active
Pump In Style Advanced	PNSA Tote	FDA UDI	Class II	Active
Invia White Foam NPWT	087.6304	FDA UDI	Class II	Active
Colostrum Protector	101046344	FDA UDI	Class II	Active
Symphony Breast Milk Initiation Kit with Silicone Tubing	101042764	FDA UDI	Class II	Active
Invia Motion 15 Days	Invia Motion	FDA UDI	Class II	Unknown
Invia Integrated Dressing	101035698	FDA UDI	Class II	Active
Enteral Feeding	ENF06019LD	FDA UDI	Class II	Active
Tubing 2M Single	080.0051	FDA UDI	Class II	Active
Hands-free O-rings	101045785	FDA UDI	Class II	Active
Enteral Feeding	NTL-60	FDA UDI	Class II	Active
Invia Motion 60 Days	Invia Motion	FDA UDI	Class II	Unknown
Enteral Feeding	ENPU-16-80	FDA UDI	Class II	Active
Bilibed	0384002	FDA UDI	Class II	Active
Enteral Feeding	TL07019	FDA UDI	Class II	Active
Invia Foam Dressing Kit	200.8905	FDA UDI	Class II	Active
Disposable overflow protection / bacteria filter	077.0572	FDA UDI	Class II	Active
Thopaz+	Thopaz+	FDA UDI	Class II	Active
Given Vario Pump Kit	080.0012	FDA UDI	Class II	Active
Hands-free Tubing	101045786	FDA UDI	Class II	Active
Symphony breast pump	Symphony plus	FDA UDI	Class II	Active
Vario rail holder	077.0825	FDA UDI	Class II	Active
Pump In Style	101041362	FDA UDI	Class II	Active
Invia Transparent Film	201.0932	FDA UDI	Class II	Active
Accessories for Vario 18 pump	080.0008	FDA UDI	Class II	Active
Holder for 2L/2.5L jar, right	077.0529	FDA UDI	Class II	Active
Double set 3l	077.0704	FDA UDI	Class II	Active
Silicone tubing	077.0921	FDA UDI	Class II	Active
Enteral Feeding	ENPU-36-65	FDA UDI	Class II	Active
Enteral Feeding	PLG10	FDA UDI	Class II	Active
Enteral Feeding	INT-03	FDA UDI	Class II	Active
Thopaz disposable canister 0.3l	079.0011	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.