The Recall Desk
HighFDA (Devices)·Z-1035-2023·Announced 2023-02-08

Non-sterile procedural knee trays recalled for potential packaging breach

Medline Industries recalls non-sterile Total Knee procedural trays because sterile blades inside can puncture the outer foil packaging. This could compromise sterile blade integrity.

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 medical device with potential risk of sterile packaging breach, but no reported illnesses or injuries. Per the rubric, products with risk of harm where injury has not been reported warrant a High (3) severity score.

Plain-English summary

Medline Industries, LP is recalling non-sterile procedural trays labeled as TOTAL KNEE KIT, Item Number DYNJ904310F. The affected product consists of 16 units (Lot Number 22IBD724) distributed in Arkansas, Maryland, Washington, and Wisconsin.

The kits contain sterile surgical blades. There is potential for these sterile blades to puncture the outer foil layer of the kit, causing a breach in the sterile packaging of the blades.

A breach in the sterile packaging could compromise the sterile integrity of the blades prior to use.

The recalled product

Product
Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Procedural Trays
Hazard
  • packaging-breach
  • 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 (4)

  • Item Number: DYNJ904310F
  • UDI/GTIN Case: 40195327116188
  • UDI/GTIN Each: 10195327116187
  • Lot Number: 22IBD724

Distribution

Distributed nationwide across the United States.

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