Saint Paul, MN, United States
Microtek Medical Inc. recalls
4 recalls recorded since 2018, most recently on 13 April 2025. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)3
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 13 April 2025
- Reason
- Due to non-sterile products being labeled as sterile
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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 adapter
Ongoing Class II Medical devices
- Recall started
- 3 June 2024
- Reason
- During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
- Distribution
- Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2640-2024, Z-2642-2024, Z-2641-2024, Z-2639-2024, Z-2643-2024
- 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).
- 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).
- 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).
- 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).
- 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).
Ongoing Class II Medical devices
- Recall started
- 23 June 2023
- Reason
- Certain lots of the products have a Naphthalene odor.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2250-2023, Z-2251-2023
- 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
- 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 Tabl
Terminated Class II Medical devices
- Recall started
- 8 April 2022
- Terminated
- 5 June 2024
- Reason
- Latex content in product was labeled incorrectly as latex free.
- Distribution
- Distributed nationwide to CO, PA, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1071-2022
- TMJ Arthroscopy Drape, 85''x 96''
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.