RegWardenFDA facility compliance records
Recall

Class II — Medline Industries, LP

Recalling firmMedline Industries, LP
Registered facilityView this company's 31 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonKits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
ProductConvenience kits CATARACT PACK DYNJ59881A
Quantity336
DistributionUS Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas.
Initiated2026-07-31
Classified2026-09-16
Recall numberZ-3210-2026
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, LP (Z-3210-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99667/

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