Agency classClass IIOur severity:High FDA (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.

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 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
Category: Medical Device — Surgical Trays / Procedural Kits
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.

Part of a larger recall action

This product is one of 38 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 38 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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