Centurion Curette kits recalled for weak seals potentially compromising sterility
Medline Industries is recalling Centurion Curette kits because some may have weak seals that could compromise product sterility. The weak seal may not be detectable during inspection.
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: This is a Class II medical device recall involving sterile surgical instruments with a potential seal weakness that could compromise sterility. While no illnesses or injuries have been reported and the hazard is theoretical, sterile instruments where sterility cannot be assured represent a significant risk of harm.
Plain-English summary
Medline Industries, LP is recalling Centurion Curette kits due to a potential weak seal in the sterilized packaging. These sterile surgical instruments include multiple curette types used in ear and dermal procedures, with nine product codes involved in the recall.
The weak seal may result in a breach of sterility of the contents if the seal fails. The seal weakness may not be detectable by users, meaning healthcare providers cannot identify which units are affected through visual inspection.
Approximately 20,614 units were distributed worldwide, including to the United States, Panama, and Canada. Healthcare facilities and professionals who have received these products should contact Medline Industries, LP for information about affected lot numbers and replacement options.
The recalled product
- Product
- Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745; b) STERILE "1" EAR CURETTE (505629), Product Code 67050; c) STERILE FOX DERMAL CURETTE, 5MM(32923), Product Code 67430; d) STERILE EXCAVATOR CURETTE (P/S), Product Code…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 20,614
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) 66745
- UDI/DI 70653160060330 (case) 00653160060331 (each)
- Lot Numbers: 2023103090
- b) 67050
- UDI/DI 00653160357509 (case) 10653160357506 (each)
- c) 67430
- UDI/DI 10653160123514 (case) 00653160123517 (each)
- Lot Numbers: 2023022190
- d) I67970
- UDI/DI 20653160224744 (case) 00653160224740 (each)
- Lot Numbers: 2023041390
- 2023041490
- 2023061990
- 2023101290
- e) I68040
- UDI/DI 20653160228605 (case) 00653160228601 (each)
- 2023102090
- f) I68340
- UDI/DI 00653160279863 (case) 10653160279860 (each)
- Lot Numbers: 2023042490
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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