Diversatek Vietnam Company Limited
2 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (2)
Devices registered here (1)
- Esophageal, Mucosal, Electrical CharacterizationProduct code QIS (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1450
Recalls & enforcement
- Class IIOngoing2026-03-18The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
- Class IITerminated2021-10-29M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2021 and 10-22-2021, may contain incorrect inner polybag labeling. The outer package labeling is correct.
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. “Diversatek Vietnam Company Limited (FEI 3009106214) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009106214-diversatek-vietnam-company-limited/
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