Diversatek Healthcare recalls
4 official recalls and safety alerts involving Diversatek Healthcare since 2022-09, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Diversatek Healthcare or the relevant agency.
- 2026-04-29
USDiversatek Healthcare recalls Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
FDA · DeviceDiversatek HealthcareUS: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ,…Official notice →- 2025-08-20
- US
Diversatek Healthcare recalls Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct…
FDA · DeviceDiversatek HealthcareWorldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the…Official notice → - 2023-09-13
- US
Diversatek Healthcare recalls ZVU Functional GI Software, REF: ZVU-3
GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
FDA · DeviceDiversatek Healthcareworldwide - US Nationwide distribution in the states of NJ, MN, TN, WA, KY,…Official notice → - 2022-09-28
- US
Diversatek Healthcare recalls Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve severed polyps,…
M-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.