Medline Bleach Germicidal Wipes Recalled for Incorrect Shelf-Life Labeling
Medline is recalling 1.3 million units of bleach germicidal wipes due to stability concerns. Products labeled for 24-month shelf life are only safe and effective for 12 months.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for shelf-life labeling error with no reported illnesses or injuries. The hazard is loss of disinfectant efficacy, not contamination or direct physical harm, consistent with precautionary labeling recalls.
Plain-English summary
Medline Industries is recalling 1,314,719 units of MEDLINE MICRO-KILL Bleach Germicidal Wipes due to shelf-life stability concerns. The recalled products include five different models distributed in the US, US territories, South Korea, Panama, and Dubai.
The company has determined that while products are labeled with a 24-month shelf life, they are only safe and effective for up to 12 months. After 12 months, stability of the bleach solution cannot be assured, and the disinfectant effectiveness may be compromised.
Consumers and healthcare facilities should check the lot numbers on their packages against the recall information. If you have affected products, stop using them after 12 months from the manufacturing date, regardless of the 24-month expiration date printed on the package.
For questions or concerns, contact Medline Industries. The FDA is monitoring this Class II medical device recall.
The recalled product
- 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) MSC35141
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- shelf-life-mislabeling
- stability-issue
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
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