The Recall Desk
HighFDA (Devices)·Z-0758-2025·Announced 2025-01-01

Medline Reprocessed Bruns Curette Surgical Instruments Recalled for Weak Sterile Seals

Medline is recalling 21,440 reprocessed Bruns curettes due to weak sterile seals that may fail without user detection. This increases the risk of contamination and infection.

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 with theoretical risk of contamination and infection due to seal failure. No illnesses or injuries have been reported, fitting the rubric criterion for risk-of-harm products without reported injury.

Plain-English summary

Medline Industries, LP is recalling 21,440 reprocessed Bruns curettes (#00, Medline Item No. 67600K, UDI 10653160382140) distributed nationwide. The devices have weak seals that may fail to maintain sterility, and this failure may not be detectable to the user.

A breach in sterile seals can allow contamination and increase the risk of infection when the instruments are used in surgical or medical procedures. Medical professionals and healthcare facilities that have received these instruments should stop using them immediately.

Affected units are identified by Lot 2023012490. Healthcare providers should contact Medline Industries or the FDA for instructions on return or replacement of recalled devices.

The recalled product

Product
ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Instruments
Hazard
  • seal-failure
  • sterility-breach
  • infection

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 (2)

  • UDI: 10653160382140 (ea) 00653160382143 (case)
  • Lot 2023012490

Distribution

Distributed nationwide across the United States.

Related recalls

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