Data / Medical devices / United States / Microtek Medical LLC
Microtek Medical LLC: FDA-registered device maker in Northfield, IL, United States, 6 510(k) clearances
Microtek Medical LLC is registered with the FDA (registration 3014342658) in Northfield, IL, United States. It lists 14 device types. The FDA files 6 510(k) clearances under its listings, the newest dated September 16, 2025. 7 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014342658
- Address
- 3 Lakes Dr, Northfield, IL, United States, 60093
- Owner or operator
- Medline Industries, LP (1417592)
- Roles
- Specification developer
- First device listed
- December 30, 1991
- Registered through
- 2027
- Brand names listed
- ACCU-SORB, AKTORmed, Accu-Wrap, Aquablation Therapy, BEDDING, Bandages, CURAD, CleanOp: bedding and cleaning supplies and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 16, 2025 | 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 | Microtek Medical, LLC | accessdata.fda.gov |
| October 25, 2001 | K011318 | VENODYNE DVT ADVANTAGE PLUS | JOW | Substantially Equivalent | Microtek Medical, Inc. | accessdata.fda.gov |
| June 18, 1981 | K811268 | BOTTLE-TO-BOTTLE | KPE | Substantially Equivalent | Medi-Plast Intl., Inc. | accessdata.fda.gov |
| June 18, 1981 | K811234 | I.V. BOTTLE (RIDGID) | KPE | Substantially Equivalent | Medi-Plast Intl., Inc. | accessdata.fda.gov |
| June 17, 1981 | K811233 | I.V. PLASTIC BAG | KPE | Substantially Equivalent | Medi-Plast Intl., Inc. | accessdata.fda.gov |
| June 16, 1981 | K811269 | GLASS VIALS | KPE | Substantially Equivalent | Medi-Plast Intl., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 3, 2024 | 94780 | Class II | Ongoing | 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. | accessdata.fda.gov |
| June 23, 2023 | 92577 | Class II | Ongoing | 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 | Certain lots of the products have a Naphthalene odor. | accessdata.fda.gov |
| April 8, 2022 | 89956 | Class II | Terminated | TMJ Arthroscopy Drape, 85''x 96'' | Latex content in product was labeled incorrectly as latex free. | accessdata.fda.gov |
| January 11, 2021 | 87173 | Class II | Terminated | 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 infe | accessdata.fda.gov |
| September 14, 2018 | 81244 | Class II | Terminated | 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 | 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. | accessdata.fda.gov |
| November 22, 2017 | 80160 | Class III | Terminated | 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 agains | The incorrect IFU was shipped with the product. | accessdata.fda.gov |
| October 13, 2017 | 78419 | Class II | Terminated | 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 mai | Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch. | accessdata.fda.gov |
Compare with other makers
- All makers of Drape, Surgical, Exempt
- All makers of Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- All makers of Container, I.V.
- All makers of Light, Surgical, Accessories
- All makers of Bandage, Elastic
- All makers of Warmer, Irrigation Solution
Updated September 16, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.