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Microtek Medical, Inc. FDA Recalls
9 recalls on file across devices, 0 of them Class I and 8 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 Class IIApr 13, 2025Due to non-sterile products being labeled as sterile |
| Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 productsClass IIJun 3, 2024During sterile barrier testing performed on the decanter pro |
| Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 productsClass IIJun 3, 2024During sterile barrier testing performed on the decanter pro |
| Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 productsClass IIJun 3, 2024During sterile barrier testing performed on the decanter pro |
| C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 prodClass IIJun 3, 2024During sterile barrier testing performed on the decanter pro |
| Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products tClass IIJun 3, 2024During sterile barrier testing performed on the decanter pro |
| Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 6362Class IIJun 23, 2023Certain lots of the products have a Naphthalene odor. |
| Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecolab Absorbent Table Cover W/Transfer Sheet &Class IIJun 23, 2023Certain lots of the products have a Naphthalene odor. |
| TMJ Arthroscopy Drape, 85''x 96''Class IIApr 8, 2022Latex content in product was labeled incorrectly as latex fr |