Sterilmed, Inc.
FDA Regulatory Profile
Sterilmed, Inc. appears in FDA public data with 9 recalls — including 1 Class I (most serious) —, 65 510(k) clearances, 5 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0574-2026, Class II) was initiated on October 8, 2025. Its most recent 510(k) clearance was granted on June 29, 2026.
Summary
- Total Recalls
- 9 (1 Class I)
- 510(k) Clearances
- 65
- Inspections
- 5
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0574-2026 | Class II | Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC | October 8, 2025 |
| Z-0573-2026 | Class II | Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Produ | October 8, 2025 |
| Z-0090-2019 | Class II | Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters | September 17, 2018 |
| Z-0213-2018 | Class I | St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F | June 2, 2017 |
| Z-2669-2017 | Class II | Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on t | May 8, 2017 |
| Z-1846-2016 | Class II | Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for m | April 26, 2016 |
| Z-0404-2016 | Class II | Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx onl | November 13, 2015 |
| Z-2819-2015 | Class II | Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model | August 24, 2015 |
| Z-0059-2015 | Class II | Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-1 | September 24, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K254149 | Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); R | June 29, 2026 |
| K240826 | Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiolog | October 11, 2024 |
| K190478 | Reprocessed ViewFlex Xtra ICE Catheter | November 14, 2019 |
| K190610 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology | August 15, 2019 |
| K182272 | Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis | April 15, 2019 |
| K161700 | SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultras | November 21, 2016 |
| K161086 | Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears wit | September 20, 2016 |
| K153006 | Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter | June 23, 2016 |
| K152090 | Reprocessed Steerable Introducer | March 23, 2016 |
| K152134 | Reprocessed Vessel Sealer | January 15, 2016 |
| K150357 | Reprocessed Electrophysiology Diagnostic Catheters | August 27, 2015 |
| K143562 | Reprocessed Cordless Ultrasonic Dissection Device | May 20, 2015 |
| K143260 | Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider | February 23, 2015 |
| K132566 | REPROCESSED HARMONIC SHEAR | June 14, 2014 |
| K133414 | REPROCESSED CLOSURE SYSTEM | January 22, 2014 |
| K123096 | REPROCESSED VESSEL SEALER | January 25, 2013 |
| K120040 | REPROCESSED SURGICAL ELECTRIC INSTRUMENT | October 5, 2012 |
| K121158 | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | August 6, 2012 |
| K121240 | REPROCESSED ENDOSCOPIC TROCARS | June 11, 2012 |
| K120204 | REPROCESSED FEMORAL COMPRESSION DEVICE | April 3, 2012 |