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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
ReasonProducts within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.
ProductCARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
Quantity36 units
DistributionUS Nationwide distribution in the state of TN.
Initiated2024-10-04
Classified2024-11-08
Recall numberZ-0349-2025
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-0349-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95563/

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