Centurion Scalpel Handles Recalled Due to Weak Seal Risk
Medline Industries is recalling Centurion scalpel handle kits due to weak seals that may compromise sterility. Users cannot always detect the defect.
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 of surgical instruments with potential for sterility loss, which poses a significant risk for infection. No illnesses or injuries reported, placing this within the High category per rubric criteria for risk-of-harm products without reported injury.
Plain-English summary
Medline Industries, LP is recalling Centurion scalpel handle kits (Product Codes 66825 and I68290) distributed worldwide. The products are sterile surgical instruments that may have weak seals.
The weak seal may allow the sterility of the contents to be compromised if the seal fails. The defect may not be visible to users before use.
Approximately 3,860 units have been distributed in the United States, Panama, and Canada. Affected lot numbers are 2023091990, 2023111590 (Product Code 66825), and 2023100690 (Product Code I68290).
Consumers and healthcare facilities should stop using these products and contact Medline Industries for return or replacement instructions. No injuries or illnesses have been reported.
The recalled product
- Product
- Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825; b) STERILE PAS #3 BLADE HANDLE (BH3PAS), Product Code I68290
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 3,860
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 (6)
- a) 66825
- UDI/DI 60653160053588 (case) 00653160053586 (each)
- Lot Numbers: 2023091990
- 2023111590
- b) I68290 UDI/DI 00653160275056 (case) 10653160275053 (each)
- Lot Numbers: 2023100690
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.
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