FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: 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)
- Recall number
- Z-1180-2024
- 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)
- Status
- Open, Classified
- Initiated
- 2023-12-20
- Posted
- 2024-02-22
- Terminated
- not on file
- Reason
- 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
- 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
- 1,314,719 units
- Distribution
- US and territories, S. Korea, Panama, and Dubai
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRJ
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28