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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 2 of 12

Device	Model / Reference	Registries	Class	Status
Disposable virus filter	101035265	FDA UDI	Class II	Active
Enteral Feeding	NGF10	FDA UDI	Class II	Unknown
Enteral Feeding	NGF-30	FDA UDI	Class II	Unknown
Single set 1l	077.0715	FDA UDI	Class II	Active
Freestyle	Freestyle Tote	FDA UDI	Class II	Active
Thopaz tubing single	079.0021	FDA UDI	Class II	Active
Enteral Feeding	TLINT10	FDA UDI	Class II	Unknown
Enteral Feeding	ENF07018LD	FDA UDI	Class II	Active
Enteral Feeding	ENPU-16-65	FDA UDI	Class II	Active
Enteral Feeding	EB-060-16	FDA UDI	Class II	Active
Thopaz tubing single, large connector	079.0025	FDA UDI	Class II	Active
Pump In Style Advanced	Pump In Style Advance Backpack	FDA UDI	Class II	Active
Enteral Feeding	ENFPU42100	FDA UDI	Class II	Unknown
Enteral Feeding	LID-30	FDA UDI	Class II	Active
Enteral Feeding	ENF003LD	FDA UDI	Class II	Active
Holder for 1L/1.5L jar, left	077.0526	FDA UDI	Class II	Active
Pump In Style Advanced	PNSA Tote	FDA UDI	Class II	Unknown
Disposable Overflow Protection / Virus Odour Filter	101035287	FDA UDI	Class II	Active
Enteral Feeding	ENFPV3665	FDA UDI	Class II	Unknown
Dominant Flex	101046567	FDA UDI	Class II	Active
Dominant Flex portable	Dominant Flex	FDA UDI	Class II	Active
ENFit Syringe 1ml	ENF01LD	FDA UDI	Class II	Active
Enteral Feeding	ENF05	FDA UDI	Class II	Active
Symphony breast pump	symphony standard	FDA UDI	Class II	Active
Invia Liberty canister 0.3l	087.0012	FDA UDI	Class II	Active
Enteral Feeding	ENPV4280	FDA UDI	Class II	Active
Enteral Feeding	ENF07019LD	FDA UDI	Class II	Active
Enteral Feeding	INT60	FDA UDI	Class II	Unknown
Disposable tubing	077.0951	FDA UDI	Class II	Active
Enteral Feeding	ENPV-26-65	FDA UDI	Class II	Active
Pump In Style® Pro	101047090	FDA UDI	Class II	Active
Pediatric Breast Pump Kit with Harmony	101046362	FDA UDI	Class II	Active
Thopaz disposable canister with solidifier, 2l	079.0019	FDA UDI	Class II	Active
Enteral Feeding	ENFDUALCAPLD	FDA UDI	Class II	Active
Holder for 1L/1.5L jar, right	077.0527	FDA UDI	Class II	Active
Enteral Feeding	NTL-10	FDA UDI	Class II	Active
Clamp holder, plastic	077.0521	FDA UDI	Class II	Active
Pump In Style Advanced	PNSA Metro Bag	FDA UDI	Class II	Unknown
Enteral Feeding	TL-INT-30	FDA UDI	Class II	Active
Silicone tube, ID 7mm, 100cm	077.0913	FDA UDI	Class II	Active
Enteral Feeding	TLINT30	FDA UDI	Class II	Unknown
Enteral Feeding	LID-60	FDA UDI	Class II	Active
Pump In Style® Hands-free Resupply Kit	101046873	FDA UDI	Class II	Active
Enteral Feeding	LID10	FDA UDI	Class II	Active
Enteral Feeding	ENPU-36-50	FDA UDI	Class II	Active
Resupply Kit Swing Maxi/Freestyle Hands-free Pump	101047293	FDA UDI	Class II	Active
Lactina Breast pump Kit	67094	FDA UDI	Class II	Unknown
Clip for Lid	077.1013	FDA UDI	Class II	Active
Sonata Breastpump	Sonata Deluxe	FDA UDI	Class II	Active
Enteral Feeding	NTL10	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.