Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Affected units: 16

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.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 7 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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