Skip to content

O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000 recallZ-0755-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Nov 12, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.

FDA root cause category: Process control

What the company is doing

On November 25, 2024, the firm notified customers via letters titled IMMEDIATE ACTION REQUIRED. Customers were informed that specific items and lots of Pure Pouch Single-Sterile and Sterile Kits are being recalled due to weak seals. Affected product must be destroyed. The letter included instructions on actions to take to be issued a credit. Customers should immediately check their stock for affected product and quarantine all units. Affected lots should be destroyed. When the recalling firm has received your completed destruction form, your account will be issued a credit, if applicable. If you have any questions, please contact 866-359-1704.

Recall details

Recall number
Z-0755-2025
Status
Open, Classified
Initiated by the company
Nov 12, 2024
Posted by the FDA
Dec 23, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
21,440 total
Product code
LRW
Distribution
US Nationwide distribution.

Product description

O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000

Code information (models, lots, serial numbers)

UDI: 10193489191349 (ea) 20193489191346 (case); Lot 2023052490

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 95843).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page