Pro-Dex Inc

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0280-2025Class IIKLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction wiSeptember 23, 2024
Z-2098-2023Class IIKLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction withFebruary 15, 2023
Z-1391-2023Class IIKLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to conneFebruary 14, 2023
Z-2340-2019Class IIPRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-September 25, 2018
Z-1094-2016Class IIBattery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max DrivDecember 23, 2015
Z-1095-2016Class IIBattery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battDecember 23, 2015