Steris Corp

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
21
Inspections
6
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0518-2016Class IIKindest Kare Antimicrobial Foaming Handwash, Hand Soap, 0.75% Triclosan, 444 ml (15 fl oz) bottles, October 27, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP BJune 6, 2025
K242773Electro Lube NXTApril 15, 2025
DEN230085VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) IndicatorNovember 12, 2024
K242189CELERITY HP Indicator Tape (PCC077)August 20, 2024
K241344MetriCide™ OPA Plus Solution Test StripJune 11, 2024
K241055Electro Lube NXTMay 31, 2024
K240760CELERITY HP Indicator TapeApril 10, 2024
K232826Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator InjectMarch 8, 2024
K233654VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing SyDecember 8, 2023
K233187Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)October 27, 2023
K232951BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (007111October 20, 2023
K233065V-PRO maX 2 Low Temperature Sterilization SystemOctober 20, 2023
K232485AMSCO 600 Steam SterilizerSeptember 13, 2023
K231488Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU ChemicalAugust 7, 2023
K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low TemperatSeptember 30, 2022
K222440Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization TraysSeptember 9, 2022
K222093V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization SystemSeptember 9, 2022
K222543AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low TemperaAugust 25, 2022
K220473CELERITY 20 HP Challenge PackMarch 18, 2022
K203223Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideJanuary 28, 2021