Microtek Medical Inc: 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.

Agency Publication Date: March 27, 2015

Affected Products

Product: FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MOTOR MODULE, REF 11110STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body fluids and microorganisms.

Lot Numbers: C10078 and C11056

Lot Numbers:

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Product: FREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body fluids and microorganisms.

Lot Numbers: C11049, C11076, C12339, C13063, C13091, C13109, C13218, C13364

Lot Numbers:

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Product: FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body fluids and microorganisms.

Lot Numbers: C9257, C9324, C10025, C10043, C10067, C10165, C10230, C10237, C11321, C11325, C12251, C13063, C13325

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Product: FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body fluids and microorganisms.

Lot Numbers: C9272 and C10078

Lot Numbers:

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Product: LAPAROSCOPIC TUBING SET, 3/16" ¿ X 10' (48cm x 304.8cm) WITH MALE LUER LOCK - STERILE, REF 24311 QTY 10/CS, STERILE EO Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.

Lot Numbers: C10104, C10272, C11080, C14052

Lot Numbers:

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Product: 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 STERILE NO LATEX Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.

Lot Numbers: C11020, C11129, C11238, C11276, C12013, C12044, C12079, C12094, C12108, C12124, C12212, C12236, C12243, C12254, C12271, C12334, C13031, C13070, C13080, C13162, C13168, C13189, C13205, C13254, C13294, C13345, C14020, C14055, C14072, C14120

Lot Numbers:

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Product: TUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\CS, STERILE EO Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.

Lot Numbers: C9336, C9355, C10005, C10015, C10050, C10065, C10126, C10189, C10214, C10224, C10265, C10320, C11122, C11154, C11270, C11315, C11335, C12051, C12089, C12101, C12121, C12130, C12201, C12268, C12304, C13002, C13018, C13043, C13070, C13093, C13155, C13190, C13228, C13281, C14052, C14147, C14174, C14195.

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Product: VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERILE Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.

Lot Numbers: C9344, C10091, C10158, C10214, C10221, C10257, C10264, C10298, C10342, C11060, C11104, C11118, C11136, C11180, C11216, C11237, C11290, C11313, C11334, C12060, C12096, C12180, C12206, C12235, C12243, C12334, C12355, C13008, C13032, C13042, C13053, C13067, C13128, C13179, C13212, C13248, C13281, C13303, C13317, C13338, C14036, C14057, C14121, C14140, C14169, C14183, C14197, C14233

Lot Numbers:

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Product: VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), WITH TUBING EXTENDER, STERILE, REF 24010, QTY 24\CS, STERILE EO Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.

Lot Numbers: C10147, C10166, C10169, C10174, C10196, C10201, C10207, C10210, C10236, C10298, C11067, C11089, C11108, C11194, C11208, C11238, C11271, C11311, C11362, C12009, C12020, C12032, C12034,C12058, C12081, C12118, C12165, C12187, C12214, C12228, C12303, C12333, C13014, C13050, C13072, C13214, C13282, C13291, C13322, C14090, C14209

Lot Numbers:

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Product: 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 evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.

Lot Numbers: C9225, C9232, C10239, C10285, C11042, C11129, C11136, C11172, C11209, C11216, C11279, C11300, C11332, C12010, C12023, C12102, C12157, C12194, C12215, C12251, C12290, C12339, C12348, C13008, C13056, C13057, C13092, C13157, C13164, C13176, C13268, C13295, C13308, C13337, C13340, C14027, C14057, C14094, C14135, C14195, C14209 C14232, C14238

Lot Numbers:

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Product: (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 LATEX Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.

Lot Numbers: C10042, C10062, C10099, C10133, C10188, C10264, C10327, C11207, C11221, C11285, C12006, C12019, C12083, C12114, C12135, C12157, C12207, C12347, C13011, C13086, C13126, C13144, C13260, C13289, C13340, C14037

Lot Numbers:

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Product: LASER RESISTANT WAND - STERILE, 7/8" X 8" (2.22cm x 20.32cm), REF 24013, QTY 10 EA, STERILE EO, NO LATEX Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.

Lot Numbers: C10102, C10141, C10161, C10326, C10341, C11024, C11055, C11098, C11153, C11215, C11265, C11284, C11326, C11342, C12020, C12101, C12152, C12201, C12276, C12339, C13031, C13100, C13175, C13254, C13291, C14052

Lot Numbers:

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Product: INTEGRAL WAND W/TUBING, STERILE, REF 24185, QTY 24/CS, STERILE EO Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.

Lot Numbers: C10081, C10138, C10181, C10231, C10235, C11269, C11311, C12005, C12051, C12065, C12143, C12172, C12199, C12363, C13015, C13085, C13148, C13189, C13213, C13240, C13295, C13319, C13365, C14104, C14167

Lot Numbers:

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 70721

Status: Resolved

Manufacturer: Microtek Medical Inc

Manufactured In: United States

Units Affected: 13 products (10 units; 38 units; 153 Units; 11 units; 270 units; 303 units; 32496 units; 30796 units; 56904 units; 5889 units; 3180 units; 6540 units; 9168 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lot Numbers: C10078 and C11056

Lot Numbers:

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Lot Numbers: C11049, C11076, C12339, C13063, C13091, C13109, C13218, C13364

Lot Numbers:

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Lot Numbers: C9257, C9324, C10025, C10043, C10067, C10165, C10230, C10237, C11321, C11325, C12251, C13063, C13325

Lot Numbers:

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Lot Numbers: C9272 and C10078

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Lot Numbers: C10104, C10272, C11080, C14052

Lot Numbers:

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 70721

Status: Resolved

Manufacturer: Microtek Medical Inc

Manufactured In: United States

Units Affected: 13 products (10 units; 38 units; 153 Units; 11 units; 270 units; 303 units; 32496 units; 30796 units; 56904 units; 5889 units; 3180 units; 6540 units; 9168 units)