Sterilmed, Inc.
Medical device manufacturer in Plymouth, MN.
65510(k) clearances
0PMA approvals
41recalls
Device types
- NLH Catheter, Recording, Electrode, Reprocessed 10
- NLQ Single-Use Reprocessed Ultrasonic Surgical… 8
- NUJ Electrosurgical, Cutting & Coagulation… 7
- NLM Laparoscope, General & Plastic Surgery… 6
- OWQ Reprocessed Intravascular Ultrasound Catheter 6
- NLF Oximeter, Reprocessed 4
- KTT Appliance, Fixation, Nail/Blade/Plate… 3
- NLL Staple, Implantable, Reprocessed 2
- JOW Sleeve, Limb, Compressible 2
- NMF Clamp, Vascular, Reprocessed 2
- NLW Electrode, Electrosurgical, Active… 1
- PNE Reprocessed Catheter Introducer 1
- NLU Forceps, Biopsy, Electric, Reprocessed 1
- NON Forceps, Biopsy, Non-Electric, Reprocessed 1
- NML Catheter, Biliary, Reprocessed 1
- FFL Dislodger, Stone, Basket, Ureteral, Metal 1
- JOS Electrode, Electrosurgical 1
- GEX Powered Laser Surgical Instrument 1
- GEI Electrosurgical, Cutting & Coagulation &… 1
- NKX Needle, Phacoemulsification, Reprocessed 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K254149 | Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System…OWQ · Traditional | 06/29/2026SE |
| K240826 | Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…NLH · Traditional | 10/11/2024SE |
| K190478 | Reprocessed ViewFlex Xtra ICE CatheterOWQ · Traditional | 11/14/2019SE |
| K190610 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyNLQ · Traditional | 08/15/2019SE |
| K182272 | Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisNLQ · Traditional | 04/15/2019SE |
| K161700 | SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D…OWQ · Traditional | 11/21/2016SE |
| K161086 | Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed…NUJ · Traditional | 09/20/2016SE |
| K153006 | Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) CatheterNLH · Traditional | 06/23/2016SE |
| K152090 | Reprocessed Steerable IntroducerPNE · Traditional | 03/23/2016SE |
| K152134 | Reprocessed Vessel SealerNUJ · Traditional | 01/15/2016SE |
| K150357 | Reprocessed Electrophysiology Diagnostic CathetersNLH · Traditional | 08/27/2015SE |
| K143562 | Reprocessed Cordless Ultrasonic Dissection DeviceNLQ · Traditional | 05/20/2015SE |
| K143260 | Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/DividerNUJ · Traditional | 02/23/2015SE |
| K132566 | Reprocessed Harmonic ShearNLQ · Traditional | 06/14/2014SE |
| K133414 | Reprocessed Closure SystemNLM · Traditional | 01/22/2014SE |
| K123096 | Reprocessed Vessel SealerNUJ · Traditional | 01/25/2013SE |
| K120040 | Reprocessed Surgical Electric InstrumentNUJ · Traditional | 10/05/2012SE |
| K121158 | Reprocessed Electrophysiology Diagnostic CathetersNLH · Traditional | 08/06/2012SE |
| K121240 | Reprocessed Endoscopic TrocarsNLM · Traditional | 06/11/2012SE |
| K120204 | Reprocessed Femoral Compression DeviceNMF · Traditional | 04/03/2012SE |
| K111794 | Reprocessed Harmonic ScalpelNLQ · Traditional | 01/11/2012SE |
| K110076 | Reprocessed 3D Diagnostic Ultrasound CatheterOWQ · Traditional | 08/18/2011SE |
| K111002 | Reprocessed Endoscopic TrocarsNLM · Traditional | 07/18/2011SE |
| K102560 | Reprocessed Pulse Oximeter SensorsNLF · Traditional | 02/18/2011SE |
| K101789 | Reprocessed Electrophysiology Diagnostic CathetersNLH · Traditional | 08/19/2010SE |
| K100707 | Reprocessed PinsNDM · Special | 06/25/2010SE |
| K092158 | Reprocessed Electrophysiology Diagnostic CathetersNLH · Traditional | 01/14/2010SE |
| K092368 | Reprocessed Pulse Oximeter SensorsNLF · Traditional | 11/03/2009SE |
| K083636 | Reprocessed External Fixation DeviceKTT · Traditional | 03/02/2009SE |
| K083060 | Reprocessed Harmonic ScalpelNLQ · Traditional | 01/09/2009SE |
| K081814 | Reprocessed ENT ShaversERL · Traditional | 12/17/2008SE |
| K081586 | Reprocessed External Fixation DeviceKTT · Traditional | 08/18/2008SE |
| K081342 | Reprocessed External Fixation AccessoriesKTT · Traditional | 08/13/2008SE |
| K073613 | Reprocessed Scissor TipsNUJ · Traditional | 02/12/2008SE |
| K070930 | Reprocessed Autosuture Gia Endoscopic StaplersNLL · Traditional | 10/18/2007SE |
| K070859 | Reprocessed Ethicon Ets Endoscopic Linear CuttersNLL · Traditional | 09/12/2007SE |
| K063844 | Reprocessed Heart Stabilizers and PositionersNQG · Traditional | 03/15/2007SE |
| K052299 | Reprocessed Endoscopic TrocarNLM · Traditional | 05/23/2006SE |
| K053188 | Reprocessed Baloon Inflation DeviceNKU · Traditional | 05/04/2006SE |
| K050136 | Reprocessed Hot Biopsy ForcepsNLU · Traditional | 07/20/2005SE |
| K042648 | Reprocessed Cold Biopsy ForcepsNON · Traditional | 07/20/2005SE |
| K051220 | Reprocessed Deflectable Electrophysiology Diagnostic CathetersNLH · Traditional | 06/14/2005SE |
| K043592 | Reprocessed Endoscopic TrocarNLM · Traditional | 05/23/2005SE |
| K050343 | Reprocessed Harmonic ScalpelsNLQ · Traditional | 04/12/2005SE |
| K043513 | Sterilmed Reprocessed Deflectable Electrophysiology Diagnostic CatheterNLH · Traditional | 03/01/2005SE |
| K043453 | Sterilemed Reprocessed Ivus Imaging CatheterOWQ · Traditional | 03/01/2005SE |
| K041127 | Modification to: Reprocessed Oximax Pulse Oximeter SensorsNLF · Traditional | 09/23/2004SE |
| K012677 | Reprocessed Pulse Oximeter SensorsNLF · Traditional | 03/28/2003SE |
| K012537 | Reprocessed Imaging CathetersOWQ · Traditional | 10/11/2002SE |
| K012678 | Reprocessed Sealed Electrophysiology Diagnostic CathetersNLH · Traditional | 08/14/2002SE |
| K012523 | Reprocessed Electrophysiology Diagnostic CathetersNLH · Traditional | 08/14/2002SE |
| K012574 | Reprocessed Femoral Compression DeviceNMF · Traditional | 07/18/2002SE |
| K012556 | Reprocessed GuidewiresNML · Traditional | 04/29/2002SE |
| K012685 | Reprocessed Endoscopic ElectrodesNLW · Traditional | 02/14/2002SE |
| K012581 | Reprocessed Stone Retrieval BasketsFFL · Traditional | 02/14/2002SE |
| K012597 | Sterilmed Reprocessed Compression SleevesJOW · Traditional | 02/11/2002SE |
| K012684 | Reprocessed Electrosurgical ElectrodeJOS · Traditional | 01/18/2002SE |
| K012682 | Reprocessed Laser ProbeGEX · Traditional | 11/08/2001SE |
| K012679 | Reprocessed RF Arthroscopy ProbesGEI · Traditional | 11/08/2001SE |
| K012579 | Reprocessed Phaco TipsNKX · Traditional | 11/08/2001SE |
| K012598 | Reprocessed Laparoscopic Electric InstumentsNUJ · Traditional | 11/07/2001SE |
| K012578 | Reprocessed Endoscopic TrocarNLM · Traditional | 11/07/2001SE |
| K012571 | Reprocessed HarmonicNLQ · Traditional | 11/07/2001SE |
| K012536 | Reprocessed Powered Arthroscopic AccessoriesHRX · Traditional | 11/02/2001SE |
| K003857 | Sterilmed Intermittent Compression System, Garment Models 400 SeriesJOW · Traditional | 10/18/2001SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0574-2026 Class II | Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV…Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or… | 10/08/2025Open, Classified |
| Z-0573-2026 Class II | Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS…Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or… | 10/08/2025Open, Classified |
| Z-0090-2019 Class II | Reprocessed Agilis Steerable Introducer: indicated for introducing various…Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for… | 09/17/2018Terminated |
| Z-0213-2018 Class I | St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm…Inadequate seal due to lack of adhesive glue | 06/02/2017Terminated |
| Z-2669-2017 Class II | Electrophysiology catheter cables are designed as electrode cables with a multi-pin…Sterilmed is recalling all lots of specific product codes of unexpired Sterilmed Reprocessed EP Ablation… | 05/08/2017Terminated |
| Z-1846-2016 Class II | Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and…Sterlilmed is recalling all unexpired Scissor Tips because of a potential manufacturing defect that can… | 04/26/2016Terminated |
| Z-0404-2016 Class II | Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed…Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. Sterilmed cannot assure… | 11/13/2015Terminated |
| Z-2819-2015 Class II | Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC)…Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot number… | 08/24/2015Terminated |
| Z-0059-2015 Class II | Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters, Catalog…Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an issue affecting… | 09/24/2014Terminated |
| Z-0577-2009 | Reamers Model #'s: HAL5091-144 and ZIMS5979-95-41 An orthopedic manual surgical…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0576-2009 | Taps Model #'s: SYN311.15 SYN311.190 SYN311.39 and SYN311.32 An orthopedic manual…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0575-2009 | Biopsy Forceps, Cold Model #'s: BAR000386 BAR000388 MIC1012 MIC1331 MIC1333 MIC1337…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0574-2009 | Open & Unused Items - This refers to a sterilization service provided by by SterilMed…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0573-2009 | TURP Electrodes Model #'s: CIRMLE-24-012 CIRMLE-24-015 OLYA22205C STO27050F STO27050G…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0572-2009 | Tourniquet Cuffs Model #'s: INSDT-7024-02 INSDT-7218-01 SMI553322 SMI7010-7002…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0571-2009 | Stone Retrieval Basket Model #': BOS390-105 Used to entrap and remove renal stones and…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0570-2009 | Scissor Tips Model #'s: AESPO888 AESPO889 ENCES0102 MIC3112 MIC3122 MIC3142 MIC3152…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0569-2009 | Saw Blade Model #'s: BIO506112 BIO506113 DEP2555-91-000 DEP5627-11-500 HAL5023-118…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0568-2009 | RF Arthroscopy Probe Model #'s: ARTA1325-01 ARTA1335-01 ARTA1345-01 ARTA1730-01…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0567-2009 | Retractors Model #'s: ADE3204 BOS820-175 LON3304 and LON3334-4G A manual surgical…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0566-2009 | Rasps Model #'s: KOMKM5100-37-113 KOMKM-82 STR1675-115 STR5100-37-113 and STR5100-37-115…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0565-2009 | Phaco Tips Model #'s: ALC30RTS ALC8065740806 ALC8065740809 ALC8065740837 ALC8065740839…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0564-2009 | Multi-Clip Applier Model #'s: APPCA080 AUT134031 AUT134046 AUT134051 AUT134053 AUT176625…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0563-2009 | Masks - Laryngeal Model #'s: AMB321-300-000 AMB321-400-000 AMB321-500-000 LMA12015…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0562-2009 | Laser Probe Model #': SYN55.26.25 Reprocessed laser probes are part of a laser delivery…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0561-2009 | Lap Instruments/Graspers/Forceps - COLD Model #'s: AUT173030 AUT174233 AUT174317…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0560-2009 | Lap Instruments/Graspers/Forceps - HOT Model #'s: AUT173016 AUT174301 AUT176643…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0559-2009 | Harmonic Scalpel Model #'s: ETHACE14S ETHACE23P ETHACE36P ETHCS14C ETHFCS9 ETHHDH05…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0558-2009 | Guidewires - Endoscopic (Jag Wires) Model #'s: MIC5658 and MIC630-100 Intended to be…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0557-2009 | Femoral Compression Device Model #'s: RAD11163 Intended for use in the compression of…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0556-2009 | External Fixation Device Model #'s: ORT99-36501 SYN390.005 SYN390.008 SYN394.84…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0555-2009 | EP Catheter Model #'s: BIOD6-DR-005-RT BIOD6-DR-010-RT DAI401381 DAI401449 DAI401904…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0554-2009 | EP Cables Model #'s: BAR560004P BIOC10MR10MSTKS BIOC5-MH/NAVMH-S CORC6-MR10/EPTR-S…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0553-2009 | Compression Sleeves Model #'s: HUNDVT10-1 and KEN5329 The SterilMed Intermittent…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0552-2009 | Colorado Electrodes Model #'s: COLN104A COLN112A and STRN103A Intended for precision…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0551-2009 | Cardiac Imaging Catheter Model #'s: ACU08267996 and ACU55790 Intended for intravascular…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0550-2009 | Burrs Model #'s: ANSL-3SB ANSL-5D ANSQD11-4OVDC HAL5056-118 HAL5056-166 HAL5091-106…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0549-2009 | Biopsy Forceps, Hot Model #'s: BAL60110 BAR000852 BAR000854 and MIC1550 Laparoscopic…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0548-2009 | Drill Bits Model #'s: DEP14043 MIC8053-019 RIC21-0438 RIC21-0439 RIC21-0441 RIC21-0442…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0547-2009 | Bed Check Model #'s: BED65815-021 BED65815-025 BED65815-025IT BED65815-030 BED65815-031…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0546-2009 | Balloon Inflation Device Model #'s: MED15-105 MED15-106 and SCI04527-01 The reprocessed…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |