Microtek Medical Inc.
8 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Microtek Medical Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-06-18FDA-DeviceClass IIMicrotek 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 adapters function as accessories for a device or drape, serving to connect a drape's drain hose to a fluid management device. Their purpose is to reduce the opening of the drain hose to a smaller size.
Due to non-sterile products being labeled as sterile
- 2024-08-28FDA-DeviceClass IITransfer 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.
- 2024-08-28FDA-DeviceClass IIVial 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.
- 2024-08-28FDA-DeviceClass IIBottle 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.
- 2024-08-28FDA-DeviceClass IIBag 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.
- 2024-08-28FDA-DeviceClass IIC-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.
- 2023-08-09FDA-DeviceClass IIEquipment 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 Table Cover w/Transfer Sheet, Model ABTSLSN, 25/case, non-sterile; Surgical Room Turnover (SRT) Kits: (3) Ecolab Genesys CleanOp Infection Control System, Model ALHS-02, 12/case, non-sterile; (4) Ecolab Genesys CleanOp Infection Control System, Model ALHS-SS-01, 12/case, non-s
Certain lots of the products have a Naphthalene odor.
- 2023-08-09FDA-DeviceClass IIEquipment 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 in), Model 60040S, pkgs. 25/case, sterile; (3) Ecolab Microtek Banded Bag with Elastic Opening, Circular, 127 cm (50 in), Model 60050S, pkgd. 25/case, sterile; (4) Ecolab Genesys Equipment Drape, Universal X-Ray Equipment Drape, 104 cm x 318 cm, Model 890017, pkgd. 6/case,
Certain lots of the products have a Naphthalene odor.
Get notified about new Microtek Medical Inc. recalls
Free weekly digest. We email when a new federal recall affects Microtek Medical Inc. or anything else in your household.
Get the Sunday Brief