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Diversatek Healthcare FDA Recalls
7 recalls on file across devices, 0 of them Class I and 6 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08Class IIMar 18, 2026The catheter inflation tag attached to the device may contai |
| Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20Class IIMar 18, 2026The catheter inflation tag attached to the device may contai |
| Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18Class IIMar 18, 2026The catheter inflation tag attached to the device may contai |
| Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15Class IIMar 18, 2026The catheter inflation tag attached to the device may contai |
| Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10Class IIIJun 4, 2025Anorectal manometry procedure kit outer kit label is mislabe |
| ZVU Functional GI Software, REF: ZVU-3Class IIIJul 25, 2023GI Software labelled as revision 3.3.0 is incorrectly labele |
| Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve sClass IIOct 29, 2021M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001 |