Medline Leg bag, REF DYND12578 recallZ-0534-2024 · MEDLINE INDUSTRIES, LP - Northfield · initiated Oct 19, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Undeclared latex
FDA root cause category: Labeling mix-ups
What the company is doing
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.
Recall details
- Recall number
- Z-0534-2024
- Status
- Open, Classified
- Initiated by the company
- Oct 19, 2023
- Posted by the FDA
- Sep 30, 2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 19406 devices
- Product code
- FAQ
- Distribution
- US and Panama
Product description
Medline Leg bag, REF DYND12578
Code information (models, lots, serial numbers)
UDI/DI 40080196990321 (case), 10080196990320 (insert), Lot Numbers: 48623040001, 48623050001, 48623060001, 48623070001, 48623080001
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline DYND12578Medline Industries, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 recall10 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 93306).
- Z-0533-2024 · Open, ClassifiedMedline Leg bag, REF DYND12574
- Z-0535-2024 · Open, ClassifiedMedline Leg bag, REF URO12573
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page