The Recall Desk
HighFDA (Devices)·Z-1444-2024·Announced 2024-04-10

Medline Centurion surgical scissors recalled due to weak seals

Medline Industries is recalling Centurion surgical scissors due to potentially weak seals that may compromise sterility. Users cannot reliably detect the defect, creating risk if compromised instruments are used in 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: FDA Class II recall of surgical instruments with potential sterility compromise. No illnesses or injuries have been reported. This qualifies as a risk-of-harm product where the hazard is contingent on seal failure.

Plain-English summary

Medline Industries, LP is recalling Centurion manual surgical scissors kits distributed worldwide, including the United States, Canada, and Panama. The recall affects approximately 568,849 units across multiple product codes and lot numbers.

The scissors are being recalled because the packaging seals may be weak and could fail, potentially breaching the sterility of the surgical instruments. A breach of sterility could expose the instruments to contamination prior to surgical use. The weak seal may not be detectable by visual inspection, making it difficult for users to identify affected packages before use.

Surgical facilities and healthcare providers with these Centurion scissors should immediately cease use and contact Medline Industries regarding return or replacement options. Users should verify their product codes and lot numbers against those listed in the official recall notice.

The recalled product

Product
Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145; b) STERILE S/B SCISSOR 4-1/2" (I142), Product Code 65940; c) STERILE S/B SCISSOR 5-1/2" (I140), Product Code 65945; d) STERILE CURV IRIS SCISSOR (IC164), Product Code 66
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Instruments
Hazard
  • weak-seal
  • 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 (20)

  • a) 65145
  • UDI/DI 60653160023758 (case) 00653160023756 (each)
  • Lot Numbers: 2023071990
  • 2023100390
  • b) 65940
  • UDI/DI 70653160018805 (case) 00653160018806 (each)
  • Lot Numbers: 2023112290
  • c) 65945
  • UDI/DI 60653160024823 (case) 00653160024821 (each)
  • Lot Numbers: 2023041290
  • 2023042890
  • 2023050190
  • 2023051890
  • 2023051990
  • 2023052290
  • 2023052490
  • 2023052590
  • 2023062090
  • 2023071490
  • 2023071790

Distribution

Distributed nationwide across the United States.

Related recalls

Same category