Centurion Sterile Trach Brush Recalled Due to Weak Seal
Medline Industries is recalling 1700 Centurion Sterile Trach Brush devices due to a potential weak seal that may breach product sterility if the seal fails. The defect may not be obvious to users.
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 an FDA Class II recall of a sterile medical device with a theoretical hazard (potential sterility breach) and no reported illnesses or injuries. Per the rubric, recalls with theoretical hazards score at most High (3).
Plain-English summary
Medline Industries, LP is recalling the Centurion STERILE TRACH BRUSH (Product Code 6225ST) due to a weak seal defect. This affects 1700 units distributed worldwide, including the United States, Panama, and Canada.
The product may have a weak seal that could result in a breach of sterility if the seal fails. A loss of sterility may allow contamination of the brush. The weak seal may not be detectable by all users.
The affected lot number is 2023021090. Units can be identified by UDI/DI 50653160004750 (case) or 00653160004755 (each).
The recalled product
- Product
- Centurion STERILE TRACH BRUSH, Product Code 6225ST
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 1,700
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 (3)
- UDI/DI 50653160004750 (case)
- 00653160004755 (each)
- Lot Numbers: 2023021090
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
See all →- CriticalIntubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
- SevereMedline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
- HighGood Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
- HighSurgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
Same hazard · weak seal
See all →- HighMedline Convenience Kits Recalled for Potential Weak Seals
FDA (Devices) · 2025-04-23
- HighMedline sterile convenience kits recalled for potentially weak packaging seals
FDA (Devices) · 2025-04-23
- HighMedline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals
FDA (Devices) · 2025-04-23
- HighMedline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals
FDA (Devices) · 2025-04-23
- HighMedline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals
FDA (Devices) · 2025-04-23
Similar recalls
- ModerateCenturion Sterile Weitlaner Retractor recalled for packaging puncture risk
FDA (Devices) · 2025-05-21
- SevereMedline recalls Centurion Laceration Trays for potential sterility defect
FDA (Devices) · 2024-03-06
- HighMedline Centurion Medical Procedure Kits Recalled for Sterility Risk
FDA (Devices) · 2024-10-30
- HighMedline Recalls Centurion CirClamp Sterile Surgical Devices for Packaging Defects
FDA (Devices) · 2024-10-30
- HighMedline Reprocessed Bruns Curette Surgical Instruments Recalled for Weak Sterile Seals
FDA (Devices) · 2025-01-01
- SevereMedline circumcision surgical kits recalled for sterility concerns
FDA (Devices) · 2024-03-06