RegWardenFDA facility compliance records
Recall

Class II — MEDLINE INDUSTRIES, LP - Northfield

Recalling firmMedline Industries, LP
Registered facilityView this company's 31 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonSurgical gowns were manufactured with the wrong sleeve.
ProductMedline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
Quantity2,100 gowns
DistributionDistribution was made to MD, OH, TN, TX, and WI. There was no government/military/foreign distribution.
Initiated2023-11-29
Classified2024-01-11
Recall numberZ-0711-2024
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 - Northfield (Z-0711-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93560/

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