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Medline Industries, LP recalls

The FDA has posted 490 enforcement recalls from Medline Industries, LP since 2025, including 69 Class I (most serious) recalls. Most recent report: Oct 7, 2026.

Class I: 69Class II: 421
Class IIOngoingZ-3269-2026

Medline Industries, LP recalls Medline Convenience Kits: 1) ANTERIOR SPINE PACK

The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neu…

  • Orthopedic Tray
  • Nonconforming Material/Component
Medline Industries, LPILSep 30, 2026
Class IIOngoingZ-3268-2026

Medline Industries, LP recalls Medline Convenience Kits: 1) MAJOR NEURO VCH

The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neu…

  • Neurological Tray
  • Nonconforming Material/Component
Medline Industries, LPILSep 30, 2026
Class IIOngoingZ-3267-2026

Medline Industries, LP recalls Medline Convenience Kits: 1) MFC CRANIOTOMY PACK

The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neu…

  • General Surgery Tray
  • Nonconforming Material/Component
Medline Industries, LPILSep 30, 2026
Class IIOngoingZ-3265-2026

Medline Industries, LP recalls Medline Convenience Kits: 1) PEDS SINUS PACK

The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neu…

  • Nose And Throat Surgical Tray Ear
  • Nonconforming Material/Component
Medline Industries, LPILSep 30, 2026
Class IIOngoingZ-3266-2026

Medline Industries, LP recalls Medline Convenience Kits: 1) MAJOR PACK

The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neu…

  • Laparoscopy Kit
  • Nonconforming Material/Component
Medline Industries, LPILSep 30, 2026
Class IOngoingZ-3125-2026

Medline Industries, LP recalls Medline Convenience Kits: 1) DYKM1000B

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides.…

  • I.V. Start Kit
  • Nonconforming Material/Component
Medline Industries, LPILSep 23, 2026

Firm name as filed with the FDA: “Medline Industries, LP”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.