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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 3 of 12

Device	Model / Reference	Registries	Class	Status
Locking Clasp DCS	077.0102	FDA UDI	Class II	Active
Enteral Feeding	ENFPU4280LD	FDA UDI	Class II	Active
Foot ON/OFF switch for Basic/Dominant	077.0723	FDA UDI	Class II	Active
Large lid with conical patient connection 6–10 mm	077.0420	FDA UDI	Class II	Active
Basic rack	Basic	FDA UDI	Class II	Active
Reusable serial connector	077.0542	FDA UDI	Class II	Active
Tubing holder right side	077.0752	FDA UDI	Class II	Active
Enteral Feeding	ENFPV1665LD	FDA UDI	Class II	Active
Enteral Feeding	ENPU-42-80	FDA UDI	Class II	Active
Enteral Feeding	ENFDUALCAP	FDA UDI	Class II	Unknown
Silicone tubing ID 6.5mm, 180cm, 1 coupling piece	077.0961	FDA UDI	Class II	Active
Enteral Feeding	ENFPU1640LD	FDA UDI	Class II	Active
Enteral Feeding	ENFPV4280	FDA UDI	Class II	Unknown
Pump In Style® Hands-free Tubing	101045766	FDA UDI	Class II	Active
Enteral Feeding	ENFPU2080LD	FDA UDI	Class II	Active
Symphony® Breast Pump Kit with Colostrum Collector	101044744	FDA UDI	Class II	Active
Enteral Feeding	ENF10	FDA UDI	Class II	Active
Breast Pump Kit with Harmony & 80mL container	101046447	FDA UDI	Class II	Active
Enteral Feeding	ENFPU2040	FDA UDI	Class II	Unknown
Enteral Feeding	ENFPV1680LD	FDA UDI	Class II	Active
Enteral Feeding	LID30	FDA UDI	Class II	Active
Single Use Silc Cup with tubing (Obstetrics)	077.0791	FDA UDI	Class II	Active
Holder for 2L/2.5L jar, left	077.0528	FDA UDI	Class II	Active
Y-piece 7/5 mm Disposable System	077.0097	FDA UDI	Class II	Active
Thopaz	Thopaz	FDA UDI	Class II	Unknown
Freestyle Hands-free	101044164	FDA UDI	Class II	Active
Symphony & Harmony Breast Milk Initiation Kit – Non Sterile	101042082	FDA UDI	Class II	Active
Enteral Feeding	ENFDOSECAPLD	FDA UDI	Class II	Active
Pump In Style Advanced	PNSA Tote	FDA UDI	Class II	Active
Enteral Feeding	ENFDUALCAPNSLD	FDA UDI	Class II	Active
Suction jar polysulfone, 0.5l	077.0155	FDA UDI	Class II	Active
Enteral Feeding	ENPU-16-40	FDA UDI	Class II	Unknown
Suction jar polysulfone 5l	077.0150	FDA UDI	Class II	Active
Enteral Feeding	PLG60	FDA UDI	Class II	Active
Invia Motion 15 Days Kit 10 x 15 cm	101045892	FDA UDI	Class II	Active
Vario 18 AC	026.0008	FDA UDI	Class II	Active
Enteral Feeding	NGW2000M	FDA UDI	Class II	Active
Pump In Style Advanced	Advanced Personal Double Breast Pump	FDA UDI	Class II	Unknown
Single set 3l, clampholder	077.0703	FDA UDI	Class II	Active
Enteral Feeding	ENFPV1650	FDA UDI	Class II	Unknown
Thopaz disposable canister with 0.3l	079.0012	FDA UDI	Class II	Active
Thopaz Sealing Cap	079.0039	FDA UDI	Class II	Active
Enteral Feeding	NGF-60ST	FDA UDI	Class II	Active
Enteral Feeding	ENPV1680	FDA UDI	Class II	Active
Symphony Single Kit-Sterile	67026S	FDA UDI	Class II	Active
Foot vacuum regulator	077.0731	FDA UDI	Class II	Active
Silicone tubing	077.0912	FDA UDI	Class II	Active
35 mL Breast Milk Collection & Storage Container	87110S-50	FDA UDI	Class II	Active
Suction bag with solidifier 1.5l	077.0084	FDA UDI	Class II	Active
Pump In Style	101041360	FDA UDI	Class II	Active

Related Companies

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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.