Agency classClass IIOur severity:High FDA (Devices)·Z-1034-2023·Announced 2023-02-08

Procedural Trays with Sterile Blades May Have Damaged Packaging

Medline Industries is recalling 45 units of procedural trays containing sterile surgical blades. The sharp blades may puncture the outer sterile packaging, potentially compromising sterility and increasing infection risk.

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 is a Class II FDA medical device recall involving surgical instruments where the hazard presents a potential risk of infection from loss of sterility. No injuries or illnesses have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported receive a score of 3 (High).

Plain-English summary

Medline Industries, LP is recalling 45 units of procedural trays labeled as THEDA CLARK TOTAL KNEE CDS that contain sterile surgical blades. The product is intended for use in surgical procedures.

The sterile blades included in these trays have the potential to puncture the outer foil packaging layer that maintains their sterility. If the packaging is breached during handling or storage, the blades may become contaminated or no longer maintain their sterile status, potentially increasing the risk of infection if used in surgical procedures.

The affected product has item number CDSOPP508AG, lot number 22HBO323, and was distributed nationwide to healthcare facilities in Arkansas, Maryland, Washington, and Wisconsin. Affected customers should cease use of these trays and contact Medline Industries for instructions regarding product return or replacement.

The recalled product

Product: Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Surgical Trays
Hazard: sterile-compromise
packaging-breach
infection-risk
Affected units: 45

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: CDSOPP508AG
UDI/GTIN Case: 40195327145140
UDI/GTIN Each: 10195327145149
Lot Number: 22HBO323

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

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 · sterile compromise