The Recall Desk
HighFDA (Devices)·Z-1449-2024·Announced 2024-04-10

Centurion Manual surgical kits recalled due to weak seals risking sterility breach

Medline's Centurion Manual surgical kits may have weak seals that fail to maintain sterility. If seals breach, microorganisms could contaminate the sterile contents, posing infection risk during surgery.

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 sterile surgical instruments with potential for loss of sterility, constituting a risk-of-harm product. No illnesses, injuries, or hospitalizations have been reported, meeting the criterion for Score 3.

Plain-English summary

Medline Industries, LP is recalling Centurion Manual surgical kits distributed worldwide, including the United States, Canada, and Panama. The recall affects six types of sterile scissors and cutters with various product codes and lot numbers.

The recalled kits may have weak seals that could fail to maintain sterility of the contents. While the weak seal may not be visually detectable by users, if the seal breaches, microorganisms could enter the sterile packaging, potentially contaminating the surgical instruments and posing an infection risk to patients.

Approximately 84,224 units have been distributed. Users should verify the lot numbers and product codes provided by the FDA to determine if they have affected units.

Healthcare facilities and individuals with affected kits should discontinue use and contact Medline or their supplier for information about replacement or return of the recalled products.

The recalled product

Product
Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Product Code 65140; b) SHARP/SHARP SCISSORS 41/2", Product Code 65840; c) STERILE WIRE CUTTER (WCS144), Product Code 66240; d) STERILE LISTER BANDAGE SCISSOR (LS122), Product Code 66855; e) STERILE
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • sterility-breach
  • infection-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 (20)

  • a) 65140
  • UDI/DI 60653160008380 (case) 00653160008388 (each)
  • Lot Numbers: 2023060790
  • 2023101090
  • b) 65840
  • UDI/DI 60653160010208 (case) 00653160010206 (each)
  • Lot Numbers: 2023022790
  • 2023041190
  • c) 66240
  • UDI/DI 60653160008793 (case) 00653160008791 (each)
  • Lot Numbers: 2023112790
  • d) 66855
  • UDI/DI 50653160007188 (case) 00653160007183 (each)
  • Lot Numbers: 2023022490
  • 2023041990
  • 2023102690
  • e) 67225
  • UDI/DI 50653160001766 (case) 00653160001761 (each)
  • Lot Numbers: 2023031690
  • 2023111490

Distribution

Distributed nationwide across the United States.