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Microtek Medical LLC

United States·US-MF-000019222

Last updated September 17, 2026

Information

Country: United States
Address: Three, Lakes Drive, Northfield, United States
Website: www.microtekmed.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1-800-Medline
PRRC Contact: Lam Duong
EUDAMED SRN: US-MF-000019222
FDA FEI Number: 3014342658
DUNS Number: 106908437

Catalogue (1418)

Page 29 of 29

Device	Model / Reference	Registries	Class	Status
Adjustable Fork Retractor	K833604	FDA 510(k)	Class I	Active
Cupped Forceps	K833605	FDA 510(k)	Class I	Active
Roller Knife-Transverse -sagittal	K833602	FDA 510(k)	Class I	Active
Microtek Medical Warming Drape	K060200	FDA 510(k)	Class II	Active
Chillbuster	K022903	FDA 510(k)	Class II	Active
Scissors Shea Bellucc	K833603	FDA 510(k)	Class I	Active
Microtek Medical Surgical Gown/Toga	K062899	FDA 510(k)	Class II	Active
Freedomaire Iii Surgical Helmet System Model 10322stk	K102971	FDA 510(k)	Class II	Active
Microtek Mini-Max Drill System	K874535	FDA 510(k)	Class II	Active
Microtek Equipment Drapes	K050322	FDA 510(k)	Class II	Active
Microtek Irrigation System	K844061	FDA 510(k)	Class I	Active
Microtek Septal Button	K862497	FDA 510(k)	U	Active
Mcgee Forceps	K833607	FDA 510(k)	Class I	Active
Microtek Stainless Steel Piston	K860460	FDA 510(k)	Class II	Active
Vivosonic Dianostic Ultrasound Imaging Coupling Media	K020956	FDA 510(k)	Class II	Active
Flexible Hydroxylapatite/Silicone Soft Chin Implan	K925610	FDA 510(k)	Class II	Active
Implant Measuring Gauge	K833606	FDA 510(k)	Class I	Active
Microtek	3827	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Microtek Medical B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (25)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 13, 2025	Z-1963-2025	—	open, classified	Due to non-sterile products being labeled as sterile
Jun 3, 2024	Z-2643-2024	—	open, classified	During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
Jun 3, 2024	Z-2639-2024	—	open, classified	During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
Jun 3, 2024	Z-2640-2024	—	open, classified	During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
Jun 3, 2024	Z-2642-2024	—	open, classified	During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
Jun 3, 2024	Z-2641-2024	—	open, classified	During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
Jun 23, 2023	Z-2251-2023	—	open, classified	Certain lots of the products have a Naphthalene odor.
Jun 23, 2023	Z-2250-2023	—	open, classified	Certain lots of the products have a Naphthalene odor.
Apr 8, 2022	Z-1071-2022	—	terminated	Latex content in product was labeled incorrectly as latex free.
Mar 10, 2015	Z-1348-2015	—	terminated	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.
Mar 10, 2015	Z-1342-2015	—	terminated	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.
Mar 10, 2015	Z-1349-2015	—	terminated	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.
Mar 10, 2015	Z-1344-2015	—	terminated	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.
Mar 10, 2015	Z-1337-2015	—	terminated	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.
Mar 10, 2015	Z-1346-2015	—	terminated	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.
Mar 10, 2015	Z-1341-2015	—	terminated	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.
Mar 10, 2015	Z-1339-2015	—	terminated	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.
Mar 10, 2015	Z-1347-2015	—	terminated	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.
Mar 10, 2015	Z-1343-2015	—	terminated	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.
Mar 10, 2015	Z-1340-2015	—	terminated	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.
Mar 10, 2015	Z-1338-2015	—	terminated	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.
Mar 10, 2015	Z-1345-2015	—	terminated	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.
Jan 5, 2011	Z-1885-2011	—	terminated	Product contains Triad Lubricating Jelly which was recalled.
Aug 23, 2010	Z-0592-2011	—	terminated	This product is being recalled due the product is miss-labeled as being sterilized by EO processing; however, the product was processed using Gamma sterilization.
May 25, 2010	Z-2109-2010	—	terminated	Product labeled as sterile was distributed without sterilization.