Recalls in Michigan
Remote Diagnostic Technologies Philips Tempus Pro Patient Monitor and USB 2-Channel IBP Module
Philips Tempus Pro Patient Monitor measures ICP and BDR but these measurements are unvalidated, potentially leading to incorrect clinical decisions.
Integra LifeSciences Codman Microsensor and CereLink ICP Sensor Basic Kits
The Codman Microsensor Basic Kit may have corrosion stains on its included needle.
2 productsSecuritas Arial 900 MHz Call Stations
Arial 900 MHz Call Stations may fail to transmit a low battery alert before battery failure.
2 productsMedline Hudson RCI Medium Concentration Oxygen Masks
Medline Hudson RCI Medium Concentration Oxygen Masks can have tubing disconnect, delaying patient care and causing shortness of breath.
IMRIS HFD100 Head Fixation Device
The Head Fixation Device HFD100 has a torque screw that may crack or separate, risking patient injury.
Philips Smart-Hopping 2.0 AP 1.4 GHz Patient Monitor
It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.
Baraka French Style Puff Pastry and Gourmet Pastry Kunafe
Baraka French Style Puff Pastry and Gourmet Pastry Kunafe may contain partially hydrogenated oils.
2 productsMeijer Steam Distilled Water
Meijer Steam Distilled Water contains a floating black foreign substance.
123Herbals Silintan 25 Pills
Silintan capsules contain undeclared meloxicam, which can cause serious life-threatening events.
Aptany Eco Sendero M/T2 Tires
Aptany Eco Sendero M/T2 tires may have sidewall separation, which can cause tire failure and increase crash risk.
McCain Foods Ore-Ida Tater Tots and Sysco Imperial Potato Tater Barrels
McCain Foods is recalling its Ore-Ida Tater Tots shaped potatoes and Sysco Imperial Potato Tater Barrel because of clear hard plastic fragments.
2 productsSpecGx Oxycodone and Acetaminophen CII Tablets
Oxycodone and Acetaminophen CII Tablets may have a missing imprint on the tablets.
2 productsAvKARE Rosuvastatin Tablets
Rosuvastatin Tablets, USP, 10 mg, are out of specification for dissolution.
Blue Bird Vision and All American Transit Buses
Wheelchair restraint retractors may not lock, allowing an unsecured wheelchair to move and increase injury risk.
Beckman Coulter UniCel DxI 600 and DxI 800 Immunoassay Systems
Beckman Coulter UniCel Dxl 600 and UniCel Dxl 800 analyzers may not restart after a standard shutdown, causing delayed results.
2 productsLS2 Rebellion Helmets
LS2 Rebellion helmets may lack proper impact protection, increasing the risk of injury during a crash.
Rivian: R1S and R1T (2022-2025)
Rivian R1S and R1T vehicles may have a toe link joint that separates, increasing the risk of a crash.
Blue Bird All American Transit Buses
All American transit buses have a loose 12-volt cable that may disconnect, causing loss of electrical systems and increasing crash risk.
Mayej Comercializadora Italian Parsley
Italian Parsley may contain Cyclospora cayetanensis.
Town Food Service Aluminum Sauce Pans
Aluminum sauce pans contain leachable lead levels.
Meridian Bioscience Revogene C. Difficile Assay
The Revogene C. difficile assay may show a decline in performance over time, leading to false-negative results.
MediNatura ReBoost and ClearLife Nasal Sprays
ReBoost Nasal Spray and ClearLife Allergy Nasal Spray contain yeast, mold, and microbial contamination.
2 productsVolvo EX30
The Volvo EX30 has a high-voltage battery that may short circuit and overheat, increasing the risk of a fire.
Roche Diagnostics Elecsys Anti-TSHR Immunoassay
The Elecsys Anti-TSHR immunoassay results vary by instrument platform and calibrator lot, which may lead to delayed or incorrect diagnosis.
Alembic Fesoterodine Fumarate Extended-Release Tablets
Failed impurities/degradation specifications due to levels of 'Diester Impurity' exceeding the specification limit.
Imprimis NJOF Dexamethasone Moxifloxacin and Tri-Moxi+ Intraocular Injections
Dexamethasone Moxifloxacin intraocular injections contain particulate matter - glass like particles.
3 productsApplied Medical Kii Low Profile Bladed Dual Pack
Kii Low Profile, Bladed Dual Pack has a potential for extended blade obturator length after assembly.
Tom Bumble Nutty Peanut Butter Flake Candy
Tom Bumble Nutty Peanut Butter Flake Candy with Peanut & Chocolate may contain foreign material.
Abbott FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors
A manufacturing issue may cause carbon build up in the sensor, leading to incorrect low glucose results.
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