Z-0534-2024Class II

Medline Leg bag, REF DYND12578

Name: Z-0534-2024 Medline Leg bag, REF DYND12578
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2023-10-19
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2023-10-19 / Open, Classified / root cause: labeling and UDI

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline Leg bag, REF DYND12578 on 2023-10-19. FDA classified it as Class II and gives the reason as "Undeclared latex". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0534-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-19
Posted: 2024-09-30
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Leg bag, REF DYND12578
Product code: FAQ Bag, Urine Collection, Leg, For External Use, Sterile
Reason for recall: Undeclared latex
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Medline issued a recall notice to its consignees on 10/16/2023 by USPS First Class Mail. The notice explained the issue, potential risk user, and requested destruction of the affected product at the consignee. Anyone who further distributed the product is directed to notify those to whom the product was distributed.
Quantity in commerce: 19406 devices
Distribution: US and Panama
Product codes and lots: UDI/DI 40080196990321 (case), 10080196990320 (insert), Lot Numbers: 48623040001, 48623050001, 48623060001, 48623070001, 48623080001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0534-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0533-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-12
Z-0534-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-12
Z-0535-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-12

Product code FAQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)