Centurion Dental Kits Recalled for Weak Seal Risk
Medline has recalled Centurion dental kits due to weak seals that may compromise sterility. No illnesses or injuries have been reported.
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 involving sterile medical devices with potential for loss of sterility. While no illnesses or injuries have been reported, the hazard poses a theoretical risk of infection if the seal fails. Per the severity rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Medline Industries, LP has recalled Centurion dental kits due to weak seals that may compromise sterility. The affected products include Dental Instrument Kits (Product Code DH760) and Sterile Cotton Dental Rolls (Product Code 9125ST6).
The weak seal may result in a breach of sterility if the seal fails during use or storage. The weak seal may not be detectable by visual inspection, so affected units could appear normal while containing non-sterile contents.
2310 units have been distributed worldwide, including the United States, Panama, and Canada. The recall affects healthcare facilities and dental practitioners who have received these products.
The recalled product
- Product
- Centurion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6; c) DENTAL INSTRUMENT KIT, Product Code DH760
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 2,310
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 (10)
- a) DH760
- UDI/DI 20653160237713 (case)
- 00653160237719 (unit)
- Lot Numbers: 2023042790
- b) 9125ST6
- UDI/DI 10653160129257 (case)
- 00653160129250 (unit)
- Lot Numbers: 2023060790
- c) DH760
- Lot Numbers: 2023110990
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
- HighCenturion Dental Kits Recalled Due to Incomplete Sterile Package Seals
FDA (Devices) · 2020-02-12
- HighMedline Centurion Medical Procedure Kits Recalled for Sterility Risk
FDA (Devices) · 2024-10-30
- SevereMedline Centurion dialysis kits recalled due to sterility concerns
FDA (Devices) · 2024-03-06
- HighCenturion Medical Recalls Daily Driveline Kits Due to Sterile Packaging Concerns
FDA (Devices) · 2019-08-14
- HighCenturion Medical Recalls Sterile NICU Line Change Kits Due to Seal Issues
FDA (Devices) · 2020-02-12
- HighRUMMELL Medline Medical Device Weak Seals Sterility Risk Recall
FDA (Devices) · 2025-01-01