Microtek Medical Inc. recall records

8 reported ongoing

9 records in this archive. Latest source date Apr 13, 2025.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

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: ...

Due to non-sterile products being labeled as sterile

Class IIReported ongoing

Distribution: U.S.: AL. AR, CA, CO, CT, FL, GA, IA, IL, IN, KY, MA, MI, NC, NY, OH, OR, TN, TX, and VA O.U.S.: N/A

Official source for Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01...
FDA device enforcement

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 IIReported ongoing

Distribution: Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.

Official source for C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek mater...
FDA device enforcement

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 IIReported ongoing

Distribution: Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.

Official source for Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material ...
FDA device enforcement

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 IIReported ongoing

Distribution: Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.

Official source for Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material ...
FDA device enforcement

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 IIReported ongoing

Distribution: Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.

Official source for Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material th...
FDA device enforcement

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 IIReported ongoing

Distribution: Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.

Official source for Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a poly/Tyvek material ...

Reasons in these listed records

  • Due to non-sterile products being labeled as sterile
  • During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
  • Certain lots of the products have a Naphthalene odor.
  • Latex content in product was labeled incorrectly as latex free.

These examples come from this result page and are not a ranking of every recall reason.

Checking Microtek Medical Inc.

Is there a recall on microtek medical inc. right now?

This archive contains 9 records, including 8 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

Keep checking