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
ReasonMedline identified that there may be a potential for voids in the packaging seal and loss of sterility on the outside of the foil pouch.
ProductCustom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products, labeled as follows: Part Description Part Number ABDOMINAL HYSTERECTOMY DYNJ906478 ABDOMINAL HYSTERECTOMY DYNJ906478A ACCESSORY HIP PACK-LF DYNJ0781865M ARTHRO/SHOULDER PACK DYNJ30056J ARTHRO/SHOULDER PACK DYNJ30056K ARTHRO/SHOULDER PACK DYNJ30056L ARTHRO/SHOULDER PACK DYNJ30056M BODY PACK DYNJ55107A BODY PACK DYNJ55107C BODY PACK DYNJ55107D C SECTION CDS CDS984613D C SECTION CDS CDS830172I C SECTION CDS CDS984613F C SECTION CDS CDS830172J C SECTION PACK CMPJ17294I C SECTION…
Quantity92,902 kits
Distributionnationwide
Initiated2020-03-09
Classified2020-05-15
Terminated2022-02-22
Recall numberZ-2040-2020
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-2040-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85581/

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