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General Purpose Dental Tray
FDA product code OFX · Class 1 · Dental
1,331
Registered devices
35
Adverse events
20
Recalls
0
510(k) clearances
Devices with this code
STRADIS HEALTHCARE — STRADIS MEDICAL, LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.STRADIS HEALTHCARE — STRADIS MEDICAL, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCAligned Medical Solutions — Aligned Medical SolutionsCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-04 | Medline Industries, LP | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie |
| 2026-03-19 | Medline Industries, LP | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market |
| 2026-01-07 | Medline Industries, LP | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster |
| 2026-01-07 | Medline Industries, LP | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster |
| 2025-03-03 | MEDLINE INDUSTRIES, LP - Northfield | There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2024-11-08 | Cardinal Health 200, LLC | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. |
| 2024-11-08 | Cardinal Health 200, LLC | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. |
| 2024-10-09 | MEDLINE INDUSTRIES, LP - Northfield | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-09-04 | MEDLINE INDUSTRIES, LP - Northfield | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product |
| 2024-06-27 | MEDLINE INDUSTRIES, LP - Northfield | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/ |
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