The Recall Desk
HighFDA (Devices)·Z-1080-2023·Announced 2023-02-15

Medline Sterile Procedural Trays Recalled Due to Blade Puncture Risk

Medline recalls sterile surgical trays (Universal Plastic and Knee Arthroscopy Pack) because sterile blades can puncture the outer foil packaging, potentially compromising sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of sterile surgical trays where blades may puncture sterile packaging, creating potential infection risk. Score applies as a risk-of-harm product without reported illnesses or injuries.

Plain-English summary

Medline Industries, LP is recalling sterile procedural trays sold as Universal Plastic and Knee Arthroscopy Pack, which contain sterile blades.

The sterile blades within these kits have the potential to puncture the outer foil layer of the sterile packaging. Puncture of the packaging could compromise the sterile environment of the contents.

The recall affects approximately 104 units distributed across 26 cases to locations worldwide, including the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates.

This is a Class II recall issued by the FDA.

The recalled product

Product
Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PACK
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • puncture
  • sterility-compromise

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • a. UNIVERSAL PLASTIC
  • Item Number: DYNJ04047C
  • Case UDI/GTIN: 40888277855060
  • Unit UDI/GTIN: 10888277855069
  • Lot Number: 22IBH860
  • 22IBJ054
  • b. KNEE ARTHROSCOPY PACK
  • Item Number: DYNJ24784C
  • Case UDI/GTIN: 40889942732587
  • Unit UDI/GTIN: 10889942732586
  • Lot Number: 22JBM001

Distribution

Distributed nationwide across the United States.