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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 21,440
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.
Part of a larger recall action
This product is one of 7 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.
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