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Microtek Medical Recalls
22 recalls on record · April 8, 2015 to June 18, 2025 · Medical Devices
Recalls by year
15
22
23
24
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 18, 2025Medical DevicesFDA
Microtek Medical, Inc. recalls Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986
Hazard: Due to non-sterile products being labeled as sterile
August 28, 2024Medical DevicesFDA
Microtek Medical Inc. recalls Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products
Hazard: During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
August 28, 2024Medical DevicesFDA
Microtek Medical Inc. recalls Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products t
Hazard: During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
August 28, 2024Medical DevicesFDA
Microtek Medical Inc. recalls Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products
Hazard: During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
August 28, 2024Medical DevicesFDA
Microtek Medical Inc. recalls Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products
Hazard: During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
August 28, 2024Medical DevicesFDA
Microtek Medical Inc. recalls C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 prod
Hazard: During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
August 9, 2023Medical DevicesFDA
Microtek Medical Inc. recalls Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecolab Absorbent Table Cover W/Transfer Sheet &
Hazard: Certain lots of the products have a Naphthalene odor.
August 9, 2023Medical DevicesFDA
Microtek Medical Inc. recalls Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 6362
Hazard: Certain lots of the products have a Naphthalene odor.
May 18, 2022Medical DevicesFDA
Microtek Medical Inc. recalls TMJ Arthroscopy Drape, 85''x 96''
Hazard: Latex content in product was labeled incorrectly as latex free.
April 8, 2015Medical DevicesFDA
Microtek Medical Inc recalls INTEGRAL WAND W/TUBING, STERILE, REF 24185, QTY 24/CS, STERILE EO Intended use: The smoke evacuator and accessories a
Hazard: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
April 8, 2015Medical DevicesFDA
Microtek Medical Inc recalls LASER RESISTANT WAND - STERILE, 7/8" X 8" (2.22cm x 20.32cm), REF 24013, QTY 10 EA, STERILE EO, NO LATEX Intended u
Hazard: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
April 8, 2015Medical DevicesFDA
Microtek Medical Inc recalls (S) TUBE SET 1/4" X 10' (0.64 cm X 304.8 cm) with 7/8" (2.22 cm) Adaptor, Sterile, REF 24155, QTY 10/CS, STERILE EO, NO
Hazard: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
April 8, 2015Medical DevicesFDA
Microtek Medical Inc recalls TUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, QTY 3/CS, NON STERILE, NO LATEX Intended use: The smoke evac
Hazard: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
April 8, 2015Medical DevicesFDA
Microtek Medical Inc recalls VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), WITH TUBING EXTENDER, STERILE, REF 24010, QTY 24\CS, STERILE EO Intended
Hazard: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
April 8, 2015Medical DevicesFDA
Microtek Medical Inc recalls VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERILE Intended use: The smoke evacuator and
Hazard: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
April 8, 2015Medical DevicesFDA
Microtek Medical Inc recalls TUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\CS, STERILE EO Intended use: The smoke evacuator and access
Hazard: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
April 8, 2015Medical DevicesFDA
Microtek Medical Inc recalls Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' (2.22 cm x 487.88 cm), REF 24244, QTY 3/CS, NON STER
Hazard: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
April 8, 2015Medical DevicesFDA
Microtek Medical Inc recalls LAPAROSCOPIC TUBING SET, 3/16" ¿ X 10' (48cm x 304.8cm) WITH MALE LUER LOCK - STERILE, REF 24311 QTY 10/CS, STERILE EO
Hazard: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
April 8, 2015Medical DevicesFDA
Microtek Medical Inc recalls FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is i
Hazard: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
April 8, 2015Medical DevicesFDA
Microtek Medical Inc recalls FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is
Hazard: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
April 8, 2015Medical DevicesFDA
Microtek Medical Inc recalls FREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to
Hazard: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
April 8, 2015Medical DevicesFDA
Microtek Medical Inc recalls FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MOTOR MODULE, REF 11110STK, QTY 1/CS, NON STE
Hazard: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.