Z-0531-2024Class II

Sterile Povidone, Ref Dynda2061

Name: Z-0531-2024 Sterile Povidone, Ref Dynda2061
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2023-11-03
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2023-11-03 / Open, Classified / root cause: labeling and UDI

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of STERILE POVIDONE, REF DYNDA2061 on 2023-11-03. FDA classified it as Class II and gives the reason as "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". 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-0531-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-03
Posted: 2023-12-11
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Sterile Povidone, Ref Dynda2061
Product code: LRO General Surgery Tray
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 300 units
Distribution: US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.
Product codes and lots: UDI/DI 40889942697633 (case), 10889942697632 (each), Lot numbers: 2022040790, 2022062190

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0531-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0525-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-11
Z-0526-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-11
Z-0527-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-11
Z-0528-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-11
Z-0529-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-11
Z-0530-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-11
Z-0531-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-11

Product code LRO

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)