Sterile Povidone, Ref Dynda2061 recallZ-0531-2024 · MEDLINE INDUSTRIES, LP - Northfield · initiated Nov 3, 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
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
FDA root cause category: Under Investigation by firm
What the company is doing
Medline Industries notified its consignees on 11/03/2023 via by email and US Mail (first class). The notice explained the issue and requested the destruction of any affected inventory. Distributor were directed to notify their customers.
Recall details
- Recall number
- Z-0531-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 3, 2023
- Posted by the FDA
- Dec 11, 2023
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 300 units
- Product code
- LRO
- Distribution
- US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.
Product description
STERILE POVIDONE, REF DYNDA2061
Code information (models, lots, serial numbers)
UDI/DI 40889942697633 (case), 10889942697632 (each), Lot numbers: 2022040790, 2022062190
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MEDLINE DYNDA2061Medline Industries, Inc. · General surgery tray1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 93395).
- Z-0525-2024 · Open, ClassifiedSTERILE PVP SOLUTION, REF DYNDA1907
- Z-0527-2024 · Open, ClassifiedSTERILE STERILE PREP STICK, REF DYNDA1134
- Z-0528-2024 · Open, ClassifiedSTERILE PVP, REF DYNDA1649
- Z-0529-2024 · Open, ClassifiedPVP SOLUTION SING STRL, REF DYNDA1858
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.
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