DYNAREX CORP.
3 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (3)
- Inspections (1)
Devices registered here (1)
- Tubes, Gastrointestinal (And Accessories)Product code KNT (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5980
Recalls & enforcement
- Class IITerminated2018-05-08The device is equipped with a dial that has an inaccurate flow rate indicator.
- Class IITerminated2016-03-03Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.
- Class IITerminated2014-07-02"THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if the wrong labeling is followed by caregivers.
FDA inspections (1)
- VAI2017-03-02Voluntary Action Indicated · Compliance: Devices · citations posted
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “DYNAREX CORP. (FEI 2431014) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2431014-dynarex-corp/
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