Microtek Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
22
510(k) Clearances
25
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1963-2025Class IIMicrotek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (0April 13, 2025
Z-2639-2024Class IIC-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek materialJune 3, 2024
Z-2643-2024Class IITransfer Device, REF 2008S. Packaged on a form, fill and seal machine with a poly/Tyvek material theJune 3, 2024
Z-2641-2024Class IIBottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material theJune 3, 2024
Z-2642-2024Class IIVial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then June 3, 2024
Z-2640-2024Class IIBag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material theJune 3, 2024
Z-2250-2023Class IIEquipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in June 23, 2023
Z-2251-2023Class IIEquipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecolab Absorbent Table CoveJune 23, 2023
Z-1071-2022Class IITMJ Arthroscopy Drape, 85''x 96''April 8, 2022
Z-1345-2015Class IIVACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), WITH TUBING EXTENDER, STERILE, REF 24010, QTY 24\CS, STMarch 10, 2015
Z-1342-2015Class IISmoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' (2.22 cm x 487.88 cm), REF 24244March 10, 2015
Z-1337-2015Class IIFREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MOTOR MODULE, REF 11110STMarch 10, 2015
Z-1348-2015Class IILASER RESISTANT WAND - STERILE, 7/8" X 8" (2.22cm x 20.32cm), REF 24013, QTY 10 EA, STERILE EO, NOMarch 10, 2015
Z-1341-2015Class IILAPAROSCOPIC TUBING SET, 3/16" ¿ X 10' (48cm x 304.8cm) WITH MALE LUER LOCK - STERILE, REF 24311 QTMarch 10, 2015
Z-1338-2015Class IIFREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet SyMarch 10, 2015
Z-1339-2015Class IIFREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO LATEX The SurgicMarch 10, 2015
Z-1346-2015Class IITUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, QTY 3/CS, NON STERILE, NO LATEX IntendedMarch 10, 2015
Z-1349-2015Class IIINTEGRAL WAND W/TUBING, STERILE, REF 24185, QTY 24/CS, STERILE EO Intended use: The smoke evacuatMarch 10, 2015
Z-1347-2015Class II(S) TUBE SET 1/4" X 10' (0.64 cm X 304.8 cm) with 7/8" (2.22 cm) Adaptor, Sterile, REF 24155, QTY 10March 10, 2015
Z-1343-2015Class IITUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\CS, STERILE EO Intended use: The smoke March 10, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (200September 16, 2025
K110358VENODYNE V810May 5, 2011
K102971FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STKFebruary 23, 2011
K062899MICROTEK MEDICAL SURGICAL GOWN/TOGAJanuary 25, 2007
K060200MICROTEK MEDICAL WARMING DRAPEMay 31, 2006
K050322MICROTEK EQUIPMENT DRAPESMay 17, 2005
K022903CHILLBUSTERNovember 27, 2002
K020956VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIAMay 16, 2002
K011318VENODYNE DVT ADVANTAGE PLUSOctober 25, 2001
K001802VENODYNE DVT ADVANTAGE MODEL 610January 9, 2001
K950906LESINSKI SURGICAL EAR DRESSINGJune 22, 1995
K925610FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLANNovember 18, 1994
K874535MICROTEK MINI-MAX DRILL SYSTEMNovember 23, 1987
K862497MICROTEK SEPTAL BUTTONJuly 14, 1986
K862496MICROTEK INTRANASAL SPLINTJuly 14, 1986
K860460MICROTEK STAINLESS STEEL PISTONJuly 11, 1986
K844061MICROTEK IRRIGATION SYSTEMMay 21, 1985
K833608GOLD ALLIGATOR FORCEPSJanuary 11, 1984
K833605CUPPED FORCEPSJanuary 3, 1984
K833606IMPLANT MEASURING GAUGEJanuary 3, 1984