Sterilmed, Inc.
Sterilmed, Inc. holds FDA 510(k) medical device clearances, first cleared 2001, most recent 2026, with 9 FDA device recalls on record.
Top product codes for Sterilmed, Inc.
FDA recalls by Sterilmed, Inc.
- Z-0574-2026 — Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Component: N/A
- Z-0573-2026 — Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135910 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Component: N/A
- Z-0090-2019 — Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c) large curl (50 mm curve type/71 cm length), Product Code STJ408324
- Z-0213-2018 — St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
- Z-2669-2017 — Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables serve two different purposes. They either serve as an extension between an EP catheter and equipment out of reach or they interface an EP catheter with the appropriate external stimulation of recording equipment.
- Z-1846-2016 — Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.
- Z-0404-2016 — Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
- Z-2819-2015 — Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106, Reprocessed by Sterilmed. Products are individually packaged in a Tyvek¿/poly pouch. There are 5 pouches placed inside a casepack box. Each sales unit (casepack) contains 5 devices.
- Z-0059-2015 — Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Sterilmed, Inc.
- K254149 — Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825) +3 more
- K240826 — Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter
- K190478 — Reprocessed ViewFlex Xtra ICE Catheter
- K190610 — Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
- K182272 — Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis
- K161700 — SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters
- K161086 — Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)
- K153006 — Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter
- K152090 — Reprocessed Steerable Introducer
- K152134 — Reprocessed Vessel Sealer
- K150357 — Reprocessed Electrophysiology Diagnostic Catheters
- K143562 — Reprocessed Cordless Ultrasonic Dissection Device
- K143260 — Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider
- K132566 — REPROCESSED HARMONIC SHEAR
- K133414 — REPROCESSED CLOSURE SYSTEM
- K123096 — REPROCESSED VESSEL SEALER
- K120040 — REPROCESSED SURGICAL ELECTRIC INSTRUMENT
- K121158 — REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
- K121240 — REPROCESSED ENDOSCOPIC TROCARS
- K120204 — REPROCESSED FEMORAL COMPRESSION DEVICE
- K111794 — REPROCESSED HARMONIC SCALPEL
- K110076 — REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER
- K111002 — REPROCESSED ENDOSCOPIC TROCARS
- K102560 — REPROCESSED PULSE OXIMETER SENSORS
- K101789 — REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
- K100707 — REPROCESSED PINS
- K092158 — REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
- K092368 — REPROCESSED PULSE OXIMETER SENSORS
- K083636 — REPROCESSED EXTERNAL FIXATION DEVICE
- K083060 — REPROCESSED HARMONIC SCALPEL
- K081814 — REPROCESSED ENT SHAVERS
- K081586 — REPROCESSED EXTERNAL FIXATION DEVICE
- K081342 — REPROCESSED EXTERNAL FIXATION ACCESSORIES
- K073613 — REPROCESSED SCISSOR TIPS
- K070930 — REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS
- K070859 — REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS
- K063844 — REPROCESSED HEART STABILIZERS AND POSITIONERS
- K052299 — REPROCESSED ENDOSCOPIC TROCAR
- K053188 — REPROCESSED BALOON INFLATION DEVICE
- K042648 — REPROCESSED COLD BIOPSY FORCEPS
- K050136 — REPROCESSED HOT BIOPSY FORCEPS
- K051220 — REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
- K043592 — REPROCESSED ENDOSCOPIC TROCAR
- K050343 — REPROCESSED HARMONIC SCALPELS
- K043453 — STERILEMED REPROCESSED IVUS IMAGING CATHETER
- K043513 — STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER
- K041127 — MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS
- K012677 — REPROCESSED PULSE OXIMETER SENSORS
- K012537 — REPROCESSED IMAGING CATHETERS
- K012523 — REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
- K012678 — REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
- K012574 — REPROCESSED FEMORAL COMPRESSION DEVICE
- K012556 — REPROCESSED GUIDEWIRES
- K012581 — REPROCESSED STONE RETRIEVAL BASKETS
- K012685 — REPROCESSED ENDOSCOPIC ELECTRODES
- K012597 — STERILMED REPROCESSED COMPRESSION SLEEVES
- K012684 — REPROCESSED ELECTROSURGICAL ELECTRODE
- K012579 — REPROCESSED PHACO TIPS
- K012679 — REPROCESSED RF ARTHROSCOPY PROBES
- K012682 — REPROCESSED LASER PROBE
- K012571 — REPROCESSED HARMONIC
- K012578 — REPROCESSED ENDOSCOPIC TROCAR
- K012598 — REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS
- K012536 — REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES
- K003857 — STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES
Data sourced from openFDA. This site is unofficial and independent of the FDA.