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Microtek Medical Inc.

Microtek Medical Inc. Recalls

All product recalls associated with Microtek Medical Inc..

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Recall Summary

Total Recalls

1000

Past Year

620

Class I (Serious)

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 961–980 of 10937 recalls

C-Flow Bag Decanter (Microtek Medical) – Packaging Integrity Issue (2024)

During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

FDAJun 3, 2024Nationwide• Microtek Medical Inc.

Transfer Device (Microtek Medical) – Packaging Integrity Issue (2024)

During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

FDAJun 3, 2024Nationwide• Microtek Medical Inc.

Bottle Decanter (Microtek Medical) – Packaging Integrity Issue (2024)

During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

FDA

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Jun 3, 2024

Nationwide

• Microtek Medical Inc.

Vial Decanter (Microtek Medical) – Packaging Integrity Issue (2024)

During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

FDAJun 3, 2024Nationwide• Microtek Medical Inc.

ABL800 FLEX Analyzer (Radiometer) – Calibration Solution Issue (2024)

Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased out-of-specification pH results on blood samples.

FDAMay 31, 2024Nationwide• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Colby Jack Cheese Slices (Tillamook) – plastic material (2024)

Plastic material. The piece of plastic material was detected in a 40lb. cheese block and smaller fragments of the plastic material may be found in the cheese slices.

Class IIModerate

FDAMay 30, 2024IN, UT, WA• Tillamook County Creamery Association

PROBEAT-FR (Hitachi) – Image Matching Software Error (2024)

During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.

FDAMay 27, 2024Nationwide• Hitachi America, Ltd., Particle Therapy Division

WOM Tube Set (WOM) – Transponder Data Error (2024)

Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery

FDAMay 24, 2024Nationwide• WOM World Of Medicine AG Alte Poststr. 11 Ludwigsstadt Germany

Endo Model M Tibial Components (Waldemar Link) – Surgical Screw Issue (2024)

Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique

FDAMay 22, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Endo Model SL Tibial Components (Waldemar Link) – Surgical Screw Problem (2024)

Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique

FDAMay 22, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Prelude Roadster Guide Sheath (Merit Medical) – Connection Risk (2024)

Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body.

FDAMay 22, 2024Nationwide• Merit Medical Systems, Inc.

Super Lube Products (Kano Laboratories) – Poisoning Risk (2024)

Fire/Burn Risk

The recall involves Super Lube products which include the following: Syncopen Synthetic Penetrant, Fire Resistant Hydraulic Fluid, and Metal Protectant and Corrosion Inhibitor. The products are used to prevent corrosion in various machinery. Super Lube Syncopen Synthetic Penetrant was sold in a four-ounce white spray bottle (item number 85004), a 32-ounce or one-quart trigger spray black plastic bottle (item number 85032), and a one-gallon (item number 85010) white plastic bottle with a handle. The container bears the brand Super Lube followed by a flag of green, blue, orange, and yellow stripes. Super Lube Fire Resistant Hydraulic Fluid was sold in a one-gallon white plastic bottle (item number 86010) with a handle. Super Lube Metal Protectant & Corrosion Inhibitor was sold in a 32-ounce or one-quart trigger spray black plastic bottle with a handle (item numbers 83032 / 83032A). The Super Lube products have one of the following lot numbers located on the bottom or rear label: Super Lube Syncopen Synthetic Penetrant Size Item Number Lot Number 1.0 Gallon Bottle 85010 17348 L24 - 23320 K26 1.0 Quart Trigger Sprayer 85032 17290 J35 - 23320 K26 4 ounce Bottle 85004 17348 L24 - 23320 K26 Super Lube Fire Resistant Hydraulic Fluid Size Item Number Lot Number 1 Gallon Bottle 86010 16120 D48 - 24040 B16 Super Lube Metal Protectant & Corrosion Inhibitor Size Item Number 1 Quart Trigger Sprayer 83032 / 83032A 17348 L24 - 23297 J49

CPSCMay 16, 2024Nationwide• Kano Laboratories LLC, of Bohemia, New York

Philips Allura Xper FD20 System (PHILIPS) – Brake Engagement Problem (2024)

When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.

FDAMay 16, 2024OK• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

TourniKwik Tourniquet Set (Medtronic) – Component Placement Error (2024)

Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.

FDAMay 16, 2024Nationwide• Medtronic Perfusion Systems

Philips Allura Xper FD10 System (PHILIPS) – Brake Engagement Issue (2024)

When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.

FDAMay 16, 2024OK• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Philips Allura Xper FD20 System (PHILIPS) – Brake Engagement Problem (2024)

When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.

FDAMay 16, 2024OK• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Inspire Model 3028 Pulse Generator (Inspire Medical) – Electrical Leakage (2024)

There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG,

FDAMay 16, 2024Nationwide• Inspire Medical Systems Inc.

A610 Clinician Programmer (Medtronic) – MRI Limitation (2024)

Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.

FDAMay 15, 2024Nationwide• Medtronic Neuromodulation

Total Knee Procedure Tray (American Contract Systems) – EO/ECH Residuals (2024)

Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.

FDAMay 15, 2024Nationwide• American Contract Systems Inc

Total Knee Procedure Kit (American Contract Systems) – EO/ECH Residuals (2024)

Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.

FDAMay 15, 2024Nationwide• American Contract Systems Inc