Manufacturer

Microtek Medical, Inc.

22 recalls in our database name Microtek Medical, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 22
Critical: 0
Severe: 1
Most recent: 2025-06-18

Of the 22 recalls from Microtek Medical, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (5%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–22 of 22

SevereFDA (Devices)·Z-1963-2025·2025-06-18
Microtek Patient Drape Adapter Plug Kits Recalled for Non-Sterile Labeling
Microtek Medical is recalling Patient Drape adapter plug kits (models AP6MMN and AP8MMN) because non-sterile products were labeled as sterile. The affected adapters are used to connect drain hoses to fluid management devices.
Product
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 adapters function as accessories for a device or drape, serving to
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-2640-2024·2024-08-28
Bag Decanter II Medical Device Recalled for Sterile Packaging Defects
Microtek Medical Inc. is recalling Bag Decanter II medical devices due to pinholes and tears identified in the sterile packaging film during quality testing, which could compromise product sterility.
Product
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).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2643-2024·2024-08-28
Transfer Device REF 2008S Sterile Barrier Packaging Defect Recall
Microtek Medical's Transfer Device REF 2008S is being recalled due to pin holes and tears in the sterile packaging barrier identified during testing. These defects compromise sterility and could allow contamination.
Product
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).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2641-2024·2024-08-28
Bottle Decanter REF 2004S Recalled for Sterile Barrier Packaging Defects
Microtek Medical Inc. is recalling Bottle Decanter REF 2004S units due to pin holes and tears found in the sterile barrier packaging during testing. Compromised packaging could allow contamination of the medical device.
Product
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).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2642-2024·2024-08-28
Vial Decanter Medical Device Recalled for Compromised Sterile Packaging
Microtek Medical Inc. recalls Vial Decanter units (REF 2006S) due to pin holes and tears in the sterile packaging film discovered during testing. Compromised sterile barriers could allow microbial contamination.
Product
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).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2639-2024·2024-08-28
C-Flow Bag Decanter Packaging Defects Prompt Sterile Barrier Recall
Microtek Medical Inc. recalls C-Flow Bag Decanters (10,366 cases) due to pin holes and tears in sterile barrier packaging discovered during quality testing. The defects could allow bacterial contamination.
Product
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).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2251-2023·2023-08-09
Surgical table drapes and infection control kits recalled for naphthalene odor
Microtek Medical Inc. is recalling certain lots of surgical table drapes and infection control kits due to detection of naphthalene odor. The affected products are distributed nationwide in the US and in Canada.
Product
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 Table Cover w/Transfer Sheet, Model ABTSLSN, 25/case, non-steril
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2250-2023·2023-08-09
Ecolab Medical Device Drapes Recalled for Naphthalene Odor
Microtek Medical Inc. is recalling certain lots of Ecolab sterile medical device drapes due to naphthalene odor. The recall affects five models distributed in the United States and Canada.
Product
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 (40 in), Model 60040S, pkgs. 25/case, sterile; (3) Ecolab M
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1071-2022·2022-05-18
TMJ Arthroscopy Drape incorrectly labeled latex-free when containing latex
Microtek Medical Inc. is recalling TMJ Arthroscopy Drapes that contain latex but were mislabeled as latex-free, posing an allergic reaction risk to patients and healthcare workers with latex sensitivities.
Product
TMJ Arthroscopy Drape, 85''x 96''
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1338-2015·2015-04-08
Microtek Medical Recalls Surgical Helmet Motor Modules for Latex Packaging
Microtek Medical Inc is recalling 38 units of FREEDOMAIRE Motor Modules because the packaging contains latex but lacks the required warning label.
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 fl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1341-2015·2015-04-08
Microtek Medical Recalls Laparoscopic Tubing Sets Due to Unlabeled Latex Packaging
Microtek Medical Inc. is recalling 270 units of sterile laparoscopic tubing sets because the packaging contains latex but lacks the required warning label.
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 procedu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1346-2015·2015-04-08
Microtek Medical Smoke Evacuator Tubing Set Recalled for Latex Packaging
Microtek Medical is recalling smoke evacuator tubing sets because the packaging contains latex but lacks the required warning label.
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 Operatin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1337-2015·2015-04-08
Microtek Medical Recalls Freedomaire Surgical Helmet Systems Due to Latex Packaging
Microtek Medical is recalling 10 Freedomaire Surgical Helmet Systems because the packaging contains latex but lacks the required warning label.
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
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1339-2015·2015-04-08
Microtek Medical Recalls Freedomaire Surgical Helmets Due to Latex Packaging
Microtek Medical Inc is recalling 153 Freedomaire Surgical Helmets because the packaging contains latex but lacks the required warning label.
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 contaminat
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1344-2015·2015-04-08
Microtek Medical Recalls Vacuum Tubing Due to Unlabeled Latex Packaging
Microtek Medical Inc is recalling non-sterile vacuum tubing because the packaging contains latex but lacks the required warning label.
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, T
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1340-2015·2015-04-08
Microtek Medical Recalls Freedomaire Surgical Helmets Due to Latex Packaging
Microtek Medical Inc is recalling 11 units of Freedomaire Surgical Helmet Systems because the packaging contains latex but lacks the required warning label.
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 contaminati
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1349-2015·2015-04-08
Microtek Medical recalls sterile smoke evacuator wands due to latex packaging
Microtek Medical is recalling sterile smoke evacuator wands because the packaging contains latex but lacks the required warning label.
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, Endosc
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1342-2015·2015-04-08
Microtek Smoke Evacuation Tubing Set Recalled for Latex Packaging Labeling Error
Microtek Medical Inc is recalling 303 Smoke Evacuation Tubing Sets because the packaging contains latex but lacks the required warning label.
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 sur
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1345-2015·2015-04-08
Microtek Medical Recalls Sterile Vacuum Tubing Due to Unlabeled Latex Packaging
Microtek Medical Inc is recalling sterile vacuum tubing because the packaging contains latex but lacks the required warning label.
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. Locati
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1347-2015·2015-04-08
Microtek Medical Smoke Evacuator Tube Sets Recalled for Latex Packaging
Microtek Medical Inc is recalling sterile smoke evacuator tube sets because the packaging contains latex without the required warning label.
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 p
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1343-2015·2015-04-08
Microtek Medical Smoke Evacuator Tubing Recalled for Unlabeled Latex Packaging
Microtek Medical is recalling smoke evacuator tubing because the packaging contains latex but lacks the required warning label.
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,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1348-2015·2015-04-08
Microtek Medical Recalls Sterile Laser Resistant Wands Due to Latex Packaging
Microtek Medical Inc is recalling sterile laser resistant wands because the packaging contains latex but lacks the required warning label.
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. Location
Category
Medical Device
Distribution
Distributed nationwide