CLASS II ONGOING Device recall · Reported 20 Dec 2023 · FDA Enforcement Report

Medline Leg recalled by MEDLINE INDUSTRIES, LP

MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Leg. The recall was initiated on 19 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 20888277719290 (case), 10888277719293 (insert), Lot Numbers: 48623050001, 48623060001

Quantity recalled144 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0535-2024
FDA event ID: 93306
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 19 Oct 2023
FDA classified: 12 Dec 2023
Reported: 20 Dec 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

19 Oct 2023	Recall initiated by company
12 Dec 2023	Classified by FDA	+54 days
20 Dec 2023	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Undeclared latex

Product as listed by the FDA

Medline Leg bag, REF URO12573

Where it was distributed

US and Panama

Questions about this recall

Is Medline Leg recalled?

Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline Leg on 19 Oct 2023. The recall is Class II and its status is Ongoing. Recall number Z-0535-2024.

Why was it recalled?

Undeclared latex

Which lots are affected?

UDI/DI 20888277719290 (case), 10888277719293 (insert), Lot Numbers: 48623050001, 48623060001

Where was it sold?

US and Panama

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from MEDLINE INDUSTRIES, LP - Northfield

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Reported	Class	Recall	Company	Reason	Where
1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	MEDLINE INDUSTRIES, LP - Northfield	Device Malfunction	6 states
1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	MEDLINE INDUSTRIES, LP - Northfield	Device Malfunction	6 states
3 Sep 2025Device	CLASS I	Medline ReNewal Reprocessed St. Jude Medical Response recalled	MEDLINE INDUSTRIES, LP - Northfield	Particulate Matter	Nationwide
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