Agency classClass IIOur severity:High FDA (Devices)·Z-1064-2023·Announced 2023-02-15

Sterile Procedural Trays Recalled Over Potential Blade Puncture of Packaging

Medline Industries is recalling sterile procedural trays because sterile blades inside could puncture the outer foil packaging, compromising sterility. The recall affects units distributed worldwide.

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: This recall affects a sterile medical device where a defect could compromise sterility. While no illnesses or injuries have been reported, the potential for contamination from a breached sterile package represents a risk-of-harm product without reported injury, meeting the rubric criterion for High severity.

Plain-English summary

Medline Industries, LP is recalling the UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Trays due to a product defect. The sterile blades contained within the sterile kits have the potential to puncture the outer foil layer of the sterile packaging. If the protective foil is compromised, the sterility of the tray cannot be assured, creating a risk of contamination for surgical use.

The affected product has been distributed worldwide, including throughout the United States, Canada, Japan, Mexico, Panama, Turks and Caicos, and the United Arab Emirates. The recalled lot is identified by Lot Number 22IBJ862, with Item Number DYNJ52230. A total of 20 cases containing 120 units have been recalled.

Patients and healthcare providers who have these trays should not use them. Facilities should identify and quarantine any remaining inventory of the affected lot and return it to Medline Industries or their distributor.

The recalled product

Product: UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Sterile Procedural Trays
Hazard: puncture
sterility-breach

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: DYNJ52230
Case UDI/GTIN: 40889942252269
Unit UDI/GTIN: 10889942252268
Lot Number: 22IBJ862

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

See all →

Critical
Intubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
Severe
Medline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
High
Good Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
High
Surgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
High
Surgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03

Same hazard · puncture