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STERIS

Medical device makerAI in IrelandAI. FDA records under 6 spellings of its name, each linked to the record.

  • Records across the group: 873, 26 entitiesAI
  • 510(k) clearances: 706
  • Device recalls: 166
  • Drug recalls: 1

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, STERIS and its 25 subsidiaries

Latest Records

Newest first across sources; each opens the record
DateRecordSource
Oct 29, 2026V-Pro maX 2 Low Temperature Sterilization SystemK263530 · MLR510(k) clearances
Oct 28, 2026VERIFY RESI-TEST SWAB Protein Detection IndicatorK260822 · SDC510(k) clearances
Oct 2, 2026MEDIVATORS™ ADVANTAGE NXT™ Automated Endoscope ReprocessorK261791 · FEB510(k) clearances
Jun 24, 2026AMSCO 700 Steam SterilizerK261055 · FLE510(k) clearances
May 1, 2026Prolystica Pass Thru Disinfectant WipesDEN240075 · SHM510(k) clearances
Apr 8, 2026SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900K251666 · MED510(k) clearances
Apr 8, 2026Celerity 5 HP Biological Indicator (LCB052)K260766 · FRC510(k) clearances
Sep 24, 2025Celerity™ 20 HP Biological IndicatorK252680 · FRC510(k) clearances
Aug 10, 2022Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test Class III · Product contains incorrect chemical indicators in packaging.Device recalls
Oct 27, 2015Kindest Kare Antimicrobial Foaming Handwash, Hand Soap, 0.75% Triclosan, 444 ml (15 fl oz) bottles, STERIS Corporation, 7501 Page Avenue, StClass II · Labeling: Not Elsewhere Classified; Incorrect/Undeclared Excipients: Outdated previous version of label applied to produDrug recalls

Subsidiaries and Divisions

25 firms in the STERIS group, most records first

Canada and Imports

Across the STERIS group, matched by company name
Active Health Canada device licences
49, as of Nov 10, 2026

Names and Identifiers

Appears as
STERIS CorporationSteris CorporationSterisSteris CorpSTERIS
Website
steris.com
Wikidata
Q80947821

Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.