Sterilmed, Inc.

FDA Regulatory Profile

Summary

Total Recalls
9 (1 Class I)
510(k) Clearances
64
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0574-2026Class IIBrand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTICOctober 8, 2025
Z-0573-2026Class IIBrand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM ProduOctober 8, 2025
Z-0090-2019Class IIReprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular cathetersSeptember 17, 2018
Z-0213-2018Class ISt. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 FJune 2, 2017
Z-2669-2017Class IIElectrophysiology catheter cables are designed as electrode cables with a multi-pin connector on tMay 8, 2017
Z-1846-2016Class IIReprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for mApril 26, 2016
Z-0404-2016Class IIZimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx onlNovember 13, 2015
Z-2819-2015Class IIZimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model August 24, 2015
Z-0059-2015Class IIBiosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-1September 24, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar ElectrophysiologOctober 11, 2024
K190478Reprocessed ViewFlex™ Xtra ICE CatheterNovember 14, 2019
K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyAugust 15, 2019
K182272Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisApril 15, 2019
K161700SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco UltrasNovember 21, 2016
K161086Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears witSeptember 20, 2016
K153006Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) CatheterJune 23, 2016
K152090Reprocessed Steerable IntroducerMarch 23, 2016
K152134Reprocessed Vessel SealerJanuary 15, 2016
K150357Reprocessed Electrophysiology Diagnostic CathetersAugust 27, 2015
K143562Reprocessed Cordless Ultrasonic Dissection DeviceMay 20, 2015
K143260Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/DividerFebruary 23, 2015
K132566REPROCESSED HARMONIC SHEARJune 14, 2014
K133414REPROCESSED CLOSURE SYSTEMJanuary 22, 2014
K123096REPROCESSED VESSEL SEALERJanuary 25, 2013
K120040REPROCESSED SURGICAL ELECTRIC INSTRUMENTOctober 5, 2012
K121158REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERSAugust 6, 2012
K121240REPROCESSED ENDOSCOPIC TROCARSJune 11, 2012
K120204REPROCESSED FEMORAL COMPRESSION DEVICEApril 3, 2012
K111794REPROCESSED HARMONIC SCALPELJanuary 11, 2012