The Recall Desk
HighFDA (Devices)·Z-1441-2024·Announced 2024-04-10

Centurion Surgical Instrument Kits Recalled for Potentially Weak Seals

Medline is recalling Centurion manual surgical kits with potentially weak seals that may result in a breach of sterility if the seal fails. The weak seal may not be detectable by all users.

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 medical device recall involving a risk of sterility breach in surgical instruments, but no illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported warrant a High severity rating.

Plain-English summary

Medline Industries is recalling Centurion manual surgical kits because they may have weak seals that could result in a breach of sterility if the seal fails. The recall affects approximately 60,075 units of various surgical instruments distributed nationwide in the United States and in Panama and Canada. The affected products were produced in 2023 and are identified by specific lot numbers.

The weak seal may not be detectable by all users, so a breach in sterility could occur without visible indication. Healthcare facilities and providers who have these recalled surgical kits should immediately stop using any units matching the affected lot numbers and contact Medline Industries for instructions on return or replacement.

For a complete list of affected product codes, lot numbers, and other recall details, consult the FDA recall notice. Contact Medline Industries directly with any questions about the affected products.

The recalled product

Product
Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256), Product Code 66225; b) ST. KELLY HEMO W/TIPS (SK8039), Product Code 66565; c) STERILE BUTTERFLY PROBE (P837), Product Code 66810; d) STERILE PROBE (PR5), Product Code 66900; e) STERILE
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) 66225
  • UDI/DI 60653160018327 (case) 00653160018325 (each)
  • Lot Numbers: 2023070390
  • b) 66565
  • UDI/DI 20653160059865 (case) 00653160059861 (each)
  • Lot Numbers: 2023022090
  • c) 66810
  • UDI/DI 60653160038547 (case) 00653160038545 (each)
  • Lot Numbers: 2023042490
  • d) 66900
  • UDI/DI 60653160038868 (case) 00653160038866 (each)
  • Lot Numbers: 2023030890
  • 2023100390
  • 2023111090
  • e) 67110
  • UDI/DI 50653160049751 (case) 00653160049756 (each)
  • 2023051590
  • 2023110290
  • f) 67285
  • UDI/DI 50653160089139 (case) 00653160089134 (each)

Distribution

Distributed nationwide across the United States.

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