Microtek Medical LLC

Tyler, TX, US

Microtek Medical LLC appears in FDA device records in Tyler, TX. FDA records list 32 510(k) clearances between 1984-01-03 and 2025-09-16, no PMA records and 5 registered establishments. As of 2026-09-10, FDA records show 42 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 32
PMA records: 0
Recall records: 42
Registered establishments: 5

FDA records under these names

1 name

FDA records resolved to Microtek Medical LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Ecolab, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 32 510(k) clearances for Microtek Medical LLC between 1984 and 2025. The busiest year on record is 1984, with 8. The most recent is 2025, with 1.

Clearances by year, as a table

510(k) clearance decisions for Microtek Medical LLC, by decision year
Year	Clearances
1984	8
1985	1
1986	3
1987	1
1988	1
1994	1
1995	1
2001	2
2002	2
2005	1
2006	1
2007	1
2011	2
2014	2
2015	1
2016	1
2018	1
2019	1
2025	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K251676	Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)	LHI	Substantially Equivalent	2025-09-16
K182164	Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand	NHV	Substantially Equivalent	2019-03-29
K173164	Ecolab POU Water Filter	NHV	Substantially Equivalent	2018-06-29
K152522	ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes	LHC	Substantially Equivalent	2016-01-15
K150190	IntraTemp Solution Warmer	LHC	Substantially Equivalent	2015-02-26
K142173	NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE	LHC	Substantially Equivalent	2014-12-30
K142080	NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED	LHC	Substantially Equivalent	2014-08-28
K110358	VENODYNE V810	JOW	Substantially Equivalent	2011-05-05
K102971	FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK	FYA	Substantially Equivalent	2011-02-23
K062899	MICROTEK MEDICAL SURGICAL GOWN/TOGA	FYA	Substantially Equivalent	2007-01-25
K060200	MICROTEK MEDICAL WARMING DRAPE	KKX	Substantially Equivalent	2006-05-31
K050322	MICROTEK EQUIPMENT DRAPES	KKX	Substantially Equivalent	2005-05-17
K022903	CHILLBUSTER	DWJ	Substantially Equivalent	2002-11-27
K020956	VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA	MUI	Substantially Equivalent	2002-05-16
K011318	VENODYNE DVT ADVANTAGE PLUS	JOW	Substantially Equivalent	2001-10-25
K001802	VENODYNE DVT ADVANTAGE MODEL 610	JOW	Substantially Equivalent	2001-01-09
K950906	LESINSKI SURGICAL EAR DRESSING	EFQ	Substantially Equivalent	1995-06-22
K925610	FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN	FWP	Substantially Equivalent	1994-11-18
K883593	#400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY	CAE	Substantially Equivalent	1988-09-30
K874535	MICROTEK MINI-MAX DRILL SYSTEM	DZI	Substantially Equivalent	1987-11-23
K862497	MICROTEK SEPTAL BUTTON	LFB	Substantially Equivalent	1986-07-14
K862496	MICROTEK INTRANASAL SPLINT	EPP	Substantially Equivalent	1986-07-14
K860460	MICROTEK STAINLESS STEEL PISTON	ETB	Substantially Equivalent	1986-07-11
K844061	MICROTEK IRRIGATION SYSTEM	GBX	Substantially Equivalent	1985-05-21
K833608	GOLD ALLIGATOR FORCEPS	KAE	Substantially Equivalent	1984-01-11
K833607	MCGEE FORCEPS	KAE	Substantially Equivalent	1984-01-03
K833606	IMPLANT MEASURING GAUGE	JYJ	Substantially Equivalent	1984-01-03
K833605	CUPPED FORCEPS	KAE	Substantially Equivalent	1984-01-03
K833604	ADJUSTABLE FORK RETRACTOR	KAL	Substantially Equivalent	1984-01-03
K833603	SCISSORS SHEA BELLUCC	JZB	Substantially Equivalent	1984-01-03
K833602	ROLLER KNIFE-TRANSVERSE -SAGITTAL	JYO	Substantially Equivalent	1984-01-03
K833601	ANTRUM & ATTIC MIRROR	KAI	Substantially Equivalent	1984-01-03

Registered establishments

FDA registered establishments for Microtek Medical LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3006116468	3006116468	Microtek Medical B.V.	HEKKEHORST 24, Zutphen Gelderland 7207 BN NL	2026	GCJ ITX JOP KME PUI
3005425620	3005425620	Microtek Medical LLC	2319 E Erwin St, TYLER, TX 75702 US	2026	KME PUI
3013401749	3013401749	Microtek Medical LLC	13000 Deerfield Parkway, Suite 300, Alpharetta, GA 30004 US	2026	FQM GZI GZJ HCC HMT IPF KME KPI KPY LHC and 1 more, listed in full below
3014342658	3014342658	Microtek Medical LLC	3 Lakes Dr, Northfield, IL 60093 US	2026	FNP FQM FTA GCY JOW KME KPE KPY LHC LHI and 2 more, listed in full below
3021970868	3021970868	Microtek Medical LLC	990 Lone Oak Road, Eagan, MN 55121 US	2026	BYY CAE EYY FNP FQM FTA GCY HMT JOL KGY and 8 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Showing 25 of 42

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1963-2025	Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient Drape, 8mm Adapter Plug Kit REF AP8MMN UDI code: (01)10748426139429 These adapters function as accessories for a device or drape, serving to connect a drape's drain hose to a fluid management device. Their purpose is to reduce the opening of the drain hose to a smaller size.	Due to non-sterile products being labeled as sterile	Class II	2025-04-13	Open, Classified
Z-2643-2024	Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).	During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.	Class II	2024-06-03	Open, Classified
Z-2642-2024	Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).	During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.	Class II	2024-06-03	Open, Classified
Z-2641-2024	Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).	During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.	Class II	2024-06-03	Open, Classified
Z-2640-2024	Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).	During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.	Class II	2024-06-03	Open, Classified
Z-2639-2024	C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).	During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.	Class II	2024-06-03	Open, Classified
Z-2251-2023	Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecolab Absorbent Table Cover W/Transfer Sheet & Armboard Covers, Model #ABTSLSAN, 20/case, non-sterile; (2) Microtek/Ecolab/CleanOp Absorbent Table Cover w/Transfer Sheet, Model ABTSLSN, 25/case, non-sterile; Surgical Room Turnover (SRT) Kits: (3) Ecolab Genesys CleanOp Infection Control System, Model ALHS-02, 12/case, non-sterile; (4) Ecolab Genesys CleanOp Infection Control System, Model ALHS-SS-01, 12/case, non-sterile; (5) Ecolab CleanOp Infection Control System, Model BPGN-02, 10/case, non-sterile; (6) Ecolab Genesys CleanOp Infection Control System, Model HFH-02, 12/case, non-sterile; (7) Ecolab Genesys CleanOp Infection Control System, Model HKHA-02, 15/case, non-sterile; (8) Ecolab CleanOp Infection Control System, Model JFKSC-01, 15/case, non-sterile; (9) Ecolab Genesys CleanOp Infection Control System, Model LH-LD-05, 12/case, non-sterile; (10) Ecolab CleanOp Infection Control System, Model NEGM-CV-01D, 9/case, non-sterile; (11) Ecolab Genesys CleanOp Infection Control System, Model PMMC-02D, 12/case, non-sterile; (12) Ecolab Genesys CleanOp Infection Control System, Model PMMC-SP-01D, 12/case, non-sterile; (13) Ecolab Genesys CleanOp Infection Control System, Model SHMC-06, 15/case, non-sterile; (14) Ecolab CleanOp Infection Control System, Model SR-01D, 12/case, non-sterile; (15) Ecolab CleanOp Infection Control System, Model SVB-OSC-01, 12/case, non-sterile; (16) Ecolab CleanOp Infection Control System, Model UCLA-LD-03, 12/case, non-sterile; (17) Ecolab CleanOp Infection Control System, Model VAIC-03, 12/case, non-sterile; and (18) Ecolab Genesys CleanOp Infection Control System, Model VAIC-CP-02, 15/case, non-sterile.	Certain lots of the products have a Naphthalene odor.	Class II	2023-06-23	Open, Classified
Z-2250-2023	Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 63620RT, pkgd. 25/case, sterile; (2) Ecolab Microtek Banded Bag with Elastic Opening, Circular, 102 cm (40 in), Model 60040S, pkgs. 25/case, sterile; (3) Ecolab Microtek Banded Bag with Elastic Opening, Circular, 127 cm (50 in), Model 60050S, pkgd. 25/case, sterile; (4) Ecolab Genesys Equipment Drape, Universal X-Ray Equipment Drape, 104 cm x 318 cm, Model 890017, pkgd. 6/case, sterile; and (5) Ecolab Genesys Microtek C-Arm / Mobile X-Ray Drape, 104 cm x 188 cm (41 in x 74 in), Model 4951N, pkgd. 50/case, sterile.	Certain lots of the products have a Naphthalene odor.	Class II	2023-06-23	Open, Classified
Z-1071-2022	TMJ Arthroscopy Drape, 85''x 96''	Latex content in product was labeled incorrectly as latex free.	Class II	2022-04-08	Terminated
Z-1141-2021	Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage: single-use equipment cover intended for use during various surgeries where warm irrigation, slush and/or cold solution is required.	Slits were identified in a low quantity of ORS-320 Slush + Warmer Disc Drapes from a single lot. A source for potential manufacturing error was identified and investigation is underway to prevent further recurrence. The slits may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment. This could pose a risk of infection to patients receiving warmed irrigation fluid or surgical slush if used during a procedure.	Class II	2021-01-11	Terminated
Z-0234-2019	Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]	The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a breach in the sterility of the product.	Class II	2018-09-14	Terminated
Z-0233-2019	Disposable Accessory Kit, 3-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]	The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a breach in the sterility of the product.	Class II	2018-09-14	Terminated
Z-0232-2019	Camera Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]	The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a breach in the sterility of the product.	Class II	2018-09-14	Terminated
Z-0231-2019	Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system Distribute by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]	The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a breach in the sterility of the product.	Class II	2018-09-14	Terminated
Z-2333-2018	ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe).	The incorrect IFU was shipped with the product.	Class III	2017-11-22	Terminated
Z-2332-2018	ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe).	The incorrect IFU was shipped with the product.	Class III	2017-11-22	Terminated
Z-0523-2018	Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches are packaged 10 each inside a poly liner. 5 rows of 10 pouches are placed in a labeled corrugated mailer box. Product Usage: Intended to be used as a disposable barrier for a surgical lighting system and which allows a surgical team member to manually adjust the lighting system. Single use device.	Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch.	Class II	2017-10-13	Terminated
Z-0753-2017	Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.	The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the incorrect expiration date (2015-10-01) on the label while the individual pouch labels and outer shipper have the correct expiration date (2018-10-01). The manufacturing date was inadvertently used as the expiration date on the inner carton box labels.	Class III	2016-11-30	Terminated
Z-2744-2016	Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.	Ecolab is recalling 2 models of Angiography Drapes with Radiation Shields because the sterile packaging may contain small holes in the film of the pouch.	Class II	2016-07-14	Terminated
Z-2793-2015	Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.	The sterile packaging may contain small (less than 250 microns wide) channels in the seal of the pouch. If channels are present, the package integrity is compromised and there is a remote chance that a non-sterile drape may be used during a surgical procedure.	Class II	2015-08-18	Terminated
Z-1349-2015	INTEGRAL WAND W/TUBING, STERILE, REF 24185, QTY 24/CS, STERILE EO Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.	This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.	Class II	2015-03-10	Terminated
Z-1348-2015	LASER RESISTANT WAND - STERILE, 7/8" X 8" (2.22cm x 20.32cm), REF 24013, QTY 10 EA, STERILE EO, NO LATEX Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.	This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.	Class II	2015-03-10	Terminated
Z-1347-2015	(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 10/CS, STERILE EO, NO LATEX Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.	This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.	Class II	2015-03-10	Terminated
Z-1346-2015	TUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, QTY 3/CS, NON STERILE, NO LATEX Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.	This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.	Class II	2015-03-10	Terminated
Z-1345-2015	VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), WITH TUBING EXTENDER, STERILE, REF 24010, QTY 24\CS, STERILE EO Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.	This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.	Class II	2015-03-10	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain