Microtek Medical, Inc.
Medical device manufacturer in Northfiled, IL.
25510(k) clearances
0PMA approvals
25recalls
Device types
- KAE Forceps, Ent 3
- JOW Sleeve, Limb, Compressible 3
- FYA Gown, Surgical 2
- KKX Drape, Surgical, Antimicrobial 2
- LFB Button, Nasal Septal 1
- LHI Set, I.V. Fluid Transfer 1
- DWJ System, Thermal Regulating 1
- MUI Media, Coupling, Ultrasound 1
- EFQ Gauze/Sponge, Internal 1
- FWP Prosthesis, Chin, Internal 1
- DZI Drill, Bone, Powered 1
- KAI Mirror, Ent 1
- EPP Splint, Nasal 1
- ETB Prosthesis, Partial Ossicular Replacement 1
- GBX Catheter, Irrigation 1
- JYJ Gauge, Measuring 1
- KAL Retractor, Ent 1
- JZB Scissors, Ear 1
- JYO Knife, Ear 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K251676 | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II…LHI · Traditional | 09/16/2025SE |
| K110358 | Venodyne V810JOW · Traditional | 05/05/2011SE |
| K102971 | Freedomaire III Surgical Helmet System Model 10322STKFYA · Traditional | 02/23/2011SE |
| K062899 | Microtek Medical Surgical Gown/TogaFYA · Traditional | 01/25/2007SE |
| K060200 | Microtek Medical Warming DrapeKKX · Traditional | 05/31/2006SE |
| K050322 | Microtek Equipment DrapesKKX · Traditional | 05/17/2005SE |
| K022903 | ChillbusterDWJ · Traditional | 11/27/2002SE |
| K020956 | Vivosonic Dianostic Ultrasound Imaging Coupling MediaMUI · Traditional | 05/16/2002SE |
| K011318 | Venodyne DVT Advantage PlusJOW · Traditional | 10/25/2001SE |
| K001802 | Venodyne DVT Advantage Model 610JOW · Traditional | 01/09/2001SE |
| K950906 | Lesinski Surgical Ear DressingEFQ · Traditional | 06/22/1995SE |
| K925610 | Flexible Hydroxylapatite/Silicone Soft Chin ImplanFWP · Traditional | 11/18/1994SE |
| K874535 | Microtek Mini-Max Drill SystemDZI · Traditional | 11/23/1987SE |
| K862497 | Microtek Septal ButtonLFB · Traditional | 07/14/1986SE |
| K862496 | Microtek Intranasal SplintEPP · Traditional | 07/14/1986SE |
| K860460 | Microtek Stainless Steel PistonETB · Traditional | 07/11/1986SE |
| K844061 | Microtek Irrigation SystemGBX · Traditional | 05/21/1985SE |
| K833608 | Gold Alligator ForcepsKAE · Traditional | 01/11/1984SE |
| K833607 | Mcgee ForcepsKAE · Traditional | 01/03/1984SE |
| K833606 | Implant Measuring GaugeJYJ · Traditional | 01/03/1984SE |
| K833605 | Cupped ForcepsKAE · Traditional | 01/03/1984SE |
| K833604 | Adjustable Fork RetractorKAL · Traditional | 01/03/1984SE |
| K833603 | Scissors Shea BelluccJZB · Traditional | 01/03/1984SE |
| K833602 | Roller Knife-Transverse -SagittalJYO · Traditional | 01/03/1984SE |
| K833601 | Antrum & Attic MirrorKAI · Traditional | 01/03/1984SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1963-2025 Class II | Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI…Due to non-sterile products being labeled as sterile | 04/13/2025Open, Classified |
| Z-2643-2024 Class II | Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a poly/Tyvek…During sterile barrier testing performed on the decanter product line, the samples were identified to have… | 06/03/2024Open, Classified |
| Z-2642-2024 Class II | Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek…During sterile barrier testing performed on the decanter product line, the samples were identified to have… | 06/03/2024Open, Classified |
| Z-2641-2024 Class II | Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek…During sterile barrier testing performed on the decanter product line, the samples were identified to have… | 06/03/2024Open, Classified |
| Z-2640-2024 Class II | Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek…During sterile barrier testing performed on the decanter product line, the samples were identified to have… | 06/03/2024Open, Classified |
| Z-2639-2024 Class II | C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a…During sterile barrier testing performed on the decanter product line, the samples were identified to have… | 06/03/2024Open, Classified |
| Z-2251-2023 Class II | Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecolab Absorbent…Certain lots of the products have a Naphthalene odor. | 06/23/2023Open, Classified |
| Z-2250-2023 Class II | Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51…Certain lots of the products have a Naphthalene odor. | 06/23/2023Open, Classified |
| Z-1071-2022 Class II | TMJ Arthroscopy Drape, 85''x 96''Latex content in product was labeled incorrectly as latex free. | 04/08/2022Terminated |
| Z-1349-2015 Class II | INTEGRAL WAND W/TUBING, STERILE, REF 24185, QTY 24/CS, STERILE EO Intended use: The…This recall is being conducted because a cohesive band used to package the devices contains latex and the… | 03/10/2015Terminated |
| Z-1348-2015 Class II | LASER RESISTANT WAND - STERILE, 7/8" X 8" (2.22cm x 20.32cm), REF 24013, QTY 10 EA…This recall is being conducted because a cohesive band used to package the devices contains latex and the… | 03/10/2015Terminated |
| Z-1347-2015 Class II | (S) TUBE SET 1/4" X 10' (0.64 cm X 304.8 cm) with 7/8" (2.22 cm) Adaptor, Sterile, REF…This recall is being conducted because a cohesive band used to package the devices contains latex and the… | 03/10/2015Terminated |
| Z-1346-2015 Class II | TUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, QTY 3/CS, NON STERILE, NO LATEX…This recall is being conducted because a cohesive band used to package the devices contains latex and the… | 03/10/2015Terminated |
| Z-1345-2015 Class II | VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), WITH TUBING EXTENDER, STERILE, REF 24010…This recall is being conducted because a cohesive band used to package the devices contains latex and the… | 03/10/2015Terminated |
| Z-1344-2015 Class II | VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERILE Intended…This recall is being conducted because a cohesive band used to package the devices contains latex and the… | 03/10/2015Terminated |
| Z-1343-2015 Class II | TUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\CS, STERILE EO Intended use:…This recall is being conducted because a cohesive band used to package the devices contains latex and the… | 03/10/2015Terminated |
| Z-1342-2015 Class II | Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' (2.22 cm x 487.88…This recall is being conducted because a cohesive band used to package the devices contains latex and the… | 03/10/2015Terminated |
| Z-1341-2015 Class II | LAPAROSCOPIC TUBING SET, 3/16" X 10' (48cm x 304.8cm) WITH MALE LUER LOCK - STERILE, REF…This recall is being conducted because a cohesive band used to package the devices contains latex and the… | 03/10/2015Terminated |
| Z-1340-2015 Class II | FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, NO LATEX…This recall is being conducted because a cohesive band used to package the devices contains latex and the… | 03/10/2015Terminated |
| Z-1339-2015 Class II | FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO LATEX…This recall is being conducted because a cohesive band used to package the devices contains latex and the… | 03/10/2015Terminated |
| Z-1338-2015 Class II | FREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical…This recall is being conducted because a cohesive band used to package the devices contains latex and the… | 03/10/2015Terminated |
| Z-1337-2015 Class II | FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MOTOR MODULE…This recall is being conducted because a cohesive band used to package the devices contains latex and the… | 03/10/2015Terminated |
| Z-1885-2011 | MDI(R), S.A.L.T. Airway Device, Supraglottic Airway Laryngopharyngeal Tube, Intended for…Product contains Triad Lubricating Jelly which was recalled. | 01/05/2011Terminated |
| Z-0592-2011 | Microtek Medical, Inc., Microscope Drape for Zeiss Standard Model/Catalog Number:…This product is being recalled due the product is miss-labeled as being sterilized by EO processing… | 08/23/2010Terminated |
| Z-2109-2010 | MICROTEK MEDICAL, INC, STACKHOUSE LASER RESISTANT SUCTION PROBE, Size: 1/4" x 9" (0.64cm…Product labeled as sterile was distributed without sterilization. | 05/25/2010Terminated |