The Recall Desk
HighFDA (Devices)·Z-1437-2024·Announced 2024-04-10

Medline Centurion Surgical Forceps Kits Recalled for Defective Seals

Medline Industries recalls 274,410 units of Centurion and Medline branded surgical forceps kits for potentially weak seals that could compromise sterility and may not be detectable during use.

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 sterile surgical instruments with weak seals that could compromise sterility. The hazard presents a risk-of-harm product where sterility breach could lead to infection during surgical use. No injuries have been reported, consistent with a High severity rating per the rubric.

Plain-English summary

Medline Industries, LP is recalling 274,410 units of Centurion Forceps kits and related Medline branded surgical forceps kits. The products are distributed in the United States, Panama, and Canada, and include multiple types of sterile surgical forceps and needleholders.

The recall is due to potentially weak seals on these sterile surgical instrument kits. A weak seal may result in a breach of sterility if the seal fails, and the weakness may not be detectable by users.

Sterile surgical forceps are intended for use during surgical procedures. If the seal is compromised and the instruments become contaminated, they may pose a risk during surgical use.

Affected users should contact Medline Industries for further instructions. No injuries or illnesses related to this recall have been reported.

The recalled product

Product
Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code 66165; b) STERILE WEBSTER NEEDLEHOLDER, Product Code 66185; c) STERILE ADSON FORCEP SERR (598), Product Code 66195; d) STERILE DRESSING FORCEP SERR (DF6003), Product Code 66200; e) STERIL
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical forceps
Hazard
Affected units
274,410

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)

  • Centurion: a) 66165
  • UDI/DI 60653160018334 (case) 00653160018332 (each)
  • Lot Numbers: 2023111790
  • b) 66185
  • UDI/DI 60653160004887 (case) 00653160004885 (each)
  • Lot Numbers: 2023041090
  • 2023072590
  • 2023120190
  • c) 66195
  • UDI/DI 60653160006638 (case) 00653160006636 (each)
  • Lot Numbers: 2023042090
  • 2023053090
  • 2023090890
  • 2023111790
  • d) 66200
  • UDI/DI 60653160022607 (case) 00653160022605 (each)
  • Lot Numbers: 2023020890
  • e) 66205
  • UDI/DI 60653160031944 (case) 00653160031942 (each)
  • Lot Numbers: 2023030390

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 29 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 29 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · defective seal

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