The Recall Desk
HighFDA (Devices)·Z-1446-2024·Announced 2024-04-10

Sterile Rubber Band Recall for Weak Seal Risk

Medline Industries, LP is recalling Centurion STERILE #16 rubber bands because the package seal may be weak, potentially compromising product sterility. The defect may not be visible to users before opening.

What this means for you

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 recall of a sterile medical device with a defective seal that could compromise product sterility. Although the defect is confirmed, no illnesses, injuries, or hospitalizations have been reported, placing this at a High severity level.

Plain-English summary

Medline Industries, LP is recalling Centurion STERILE #16 rubber bands (Product Code EB16). The recall affects 150 units distributed worldwide, including the United States, Panama, and Canada. The affected lots are 2023022290 and 2023041190.

The product may have a weak seal that could allow the sterility of the package to be compromised. The weak seal may not be visible to the user when inspecting the package, which means the product could be used while already compromised.

Healthcare facilities and medical professionals who have received this product should stop using it immediately and check the lot number on their inventory.

If you have any questions or believe you may have a compromised product, contact Medline Industries or the FDA.

The recalled product

Product
Centurion STERILE #16 RUBBER BAND, Product Code EB16
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • weak-seal
  • contamination-risk

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 (3)

  • UDI/DI 10653160129240 (case) 00653160129243 (each)
  • Lot Numbers: 2023022290
  • 2023041190

Distribution

Distributed nationwide across the United States.