CLASS II ONGOING Device recall · Reported 28 Feb 2024 · FDA Enforcement Report

These wipes are saturated with 0.65% bleach solution recalled

Medline Industries LP - Northfield is recalling These wipes are saturated with 0.65% bleach solution. The recall was initiated on 20 Dec 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) 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

Quantity recalled1,314,719 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1180-2024
FDA event ID: 93745
Recalling firm: Medline Industries LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 20 Dec 2023
FDA classified: 22 Feb 2024
Reported: 28 Feb 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

20 Dec 2023	Recall initiated by company
22 Feb 2024	Classified by FDA	+64 days
28 Feb 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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)

Where it was distributed

US and territories, S. Korea, Panama, and Dubai

Questions about this recall

Why was it recalled?

There is stability concern for products dated with a 24-month shelf life. Product is safe and effective up to 12 months shelf life.

Which lots are affected?

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

Where was it sold?

US and territories, S. Korea, Panama, and Dubai

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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