RegWardenFDA facility compliance records
Recall

Class II — Medline Industries Inc

Recalling firmMedline Industries, LP
Registered facilityView this company's 31 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonVoids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.
ProductMedline Winged Sponges Presaturated W/PVP REF DYND70289 DYND70289H Expiration 06/30/2022.
Quantity117,874 units
DistributionUS 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.
Initiated2020-02-10
Classified2020-03-20
Terminated2023-02-13
Recall numberZ-1545-2020
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Medline Industries Inc (Z-1545-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85022/

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