Z-1180-2024Class II

These wipes are saturated with 0.65% bleach solution. These wipes are antimicrobial, disinfectant with...

Name: Z-1180-2024 These wipes are saturated with 0.65% bleach solution. These wipes are antimicrobial, disinfectant with...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2023-12-20
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2023-12-20 / Open, Classified / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of These wipes are saturated with 0.65% bleach solution. These wipes are antimicrobial, disinfectant with sporicidal, virucidal, bactericidal, and fungicidal... on 2023-12-20. FDA classified it as Class II and gives the reason as "There is stability concern for products dated with a 24-month shelf life. Product is safe and effective up to 12 months shelf life". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1180-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-20
Posted: 2024-02-22
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: These wipes are saturated with 0.65% bleach solution. These wipes are antimicrobial, disinfectant with sporicidal, virucidal, bactericidal, and fungicidal activites. MEDLINE MICRO-KILL Bleach GERMICIDAL BLEACH WIPES: a) MSC351400AN/Z (7 X 8 , 150 ct canister), b) MSC351410AN/Z (6 x 5 , 150ct canister), c) MSC3560012 (private-labeled 6 x 5 , 150ct canister), d) MSC351450AN (12" x 12", 110ct bucket), e) MSC351450BG4 (12" x 12", 110ct bag)
Product code: LRJ Disinfectant, Medical Devices
Reason for recall: There is stability concern for products dated with a 24-month shelf life. Product is safe and effective up to 12 months shelf life.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medline Industries, LP issued an IMMEDIATE ACTION REQUIRED notice to it consignees on 12/20/2023 via USPS first class mail. The notice explained the problem with the device and requested that the consignee destroy all affected product. Any parties to whom the product was transferred must be notified of the recall communication. For questions, please contact 866-359-1704.
Quantity in commerce: 1,314,719 units
Distribution: US and territories, S. Korea, Panama, and Dubai
Product codes and lots: a) MSC351400AN, UDI/DI 10888277652514, Lot Numbers: 012422C, 012422C2, 020822C, 022422C, 022622C, 030522C, 032522C, 032922C, 033022C, 033122C, 040422C, 042822C, 050622C, 052022C4, 061722C, 080222C2, 090622C, 100222C, 102722C2, 102822C, 110422C, 110422C2, 110722C, 120222C, 120322C, 120722C, 122222C, 122822C, 011123C, 011323C, 011923C, 011923C2, 012523C, 012623C, 030823C, 030923C, 040423C, 042823C, 050923C, 051223C, 051723C, 060723V, 060923C, 061023C, 061023C2, 081123C, 081423C, 081823C, 082823C, 091423C, 102323C, 102423C, 111323C, 111423C; b) MSC351410AN, UDI/DI 10888277652521, Lot Numbers: 012522C, 020322C, 020622C, 020522C, 021122C2, 021222C, 021822C, 022722C, 022822C, 030222C, 030322C, 030822C, 030922C, 032922C, 042222C, 052022C3, 061722C2, 080222C, 090922C2, 102622C, 102722C, 102822C, 120122C, 120522C, 120622C, 122322C2, 122822C2, 010323C, 010523C, 030323C, 030723C, 032823C, 050323C, 050323C2, 051923C, 061223C, 061523C, 061923C, 062022C2, 062323C, 080323C, 082323C, 082423C, 082523C, 101223C, 103023C, 111423C, 111523C, 111623C; c) MSC351450AN, UDI/DI 80080196314521, Lot Numbers: 090922B, 033023V, 060723V; d) MSC3560012, UDI/DI 847713000350, Lot Numbers: 102022C, 102122C, 102122C2, 102422C, 102522C, 021523C, 021623C, 022023C, 022223C, 040423C, 041023C, 041223C, 102423C2, 102623C2, 102723C2; e) MSC351450BG4, UDI/DI 00193489015242, Lot Numbers: 090922B, 033023V, 060723V

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1180-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1180-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-22

Product code LRJ

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)