CLASS II Device recall · Reported 1 Apr 2020 · FDA Enforcement Report

Medline Stick Sponge Presaturated W/PVP recalled by Medline Industries

Medline Industries is recalling Medline Stick Sponge Presaturated W/PVP, distributed nationwide in the US. The recall was initiated on 10 Feb 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF DYND70288 2/PK Expiration 06/30/2022

Quantity recalled1,541,532 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-1544-2020
FDA event ID: 85022
Recalling firm: Medline Industries, Northfield, IL
Classification: Class II
Status: Terminated
Recall initiated: 10 Feb 2020
FDA classified: 20 Mar 2020
Reported: 1 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

10 Feb 2020	Recall initiated by company
20 Mar 2020	Classified by FDA	+39 days
1 Apr 2020	Published in enforcement report	+12 days

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

Reason for recall

Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022.

Where it was distributed

US Nationwide: MA, LA, IL, MO, MI, MN, NJ, KS, GA, NY, PA, SD, CT, TN, MD, OH, VA, FL, TX, KY, CO, IN, AL, CA, MT, OR, AK, AL, DC, IA, ME, NV, NE, SC, WV, WY, RI, NC, AZ, UT, DE and WI.

Nationwide Alaska Alabama Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan

Questions about this recall

Is Medline Stick Sponge Presaturated W/PVP recalled?

Yes. Medline Industries recalled Medline Stick Sponge Presaturated W/PVP on 10 Feb 2020. The recall is Class II and its status is Terminated. Recall number Z-1544-2020.

Why was it recalled?

Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.

Which lots are affected?

REF DYND70288 2/PK Expiration 06/30/2022

Where was it sold?

US Nationwide: MA, LA, IL, MO, MI, MN, NJ, KS, GA, NY, PA, SD, CT, TN, MD, OH, VA, FL, TX, KY, CO, IN, AL, CA, MT, OR, AK, AL, DC, IA, ME, NV, NE, SC, WV, WY, RI, NC, AZ, UT, DE and WI.

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 21 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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