Health Canada Issues Type III Recall of Aleve Caplets Over Distribution Error
Aleve 200 mg caplets by Aleve
Customer-returned products were inadvertently reintroduced into saleable inventory and distributed to the wholesale level. Health Canada…
Aleve 200 mg caplets by Aleve
Customer-returned products were inadvertently reintroduced into saleable inventory and distributed to the wholesale level. Health Canada…
Aleve caplets by Aleve
Customer-returned products were inadvertently reintroduced into saleable inventory and distributed to the wholesale level. The notice…
HemosIL AcuStar HIT-IgG(PF4-H) by Instrumentation Laboratory Co.
A performance issue with Lot B38062 may result in a negative analytical bias and calibration-related failures.…
cobas c 303 analytical unit by Roche Diagnostics GmbH
Vacuum tubing in the cell rinse unit can deteriorate prematurely. If the tubing ruptures, fluid may…
Tracoe Experc Percut Dilation Tracheostomy Set W/Trachatraumatic Inserter by Tracoe Medical GmbH
The silicone sleeve may detach from the guiding catheter when the insertion system of the tracheostomy…
CareLink SmartSync Device Manager by Medtronic Inc.
Bluetooth disconnections during a SmartSync patient session may lead to harm due to undesirable or incomplete…
Philips Allura Xper Systems by Philips Medical Systems Nederland
A software issue may cause the FlexVision application to become unresponsive during clinical use. The FlexVision…
Argatroban Injection 250 mg/2.5 mL (100 mg/mL) by Par Health and Endo USA
The injection may contain particulate matter, identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly…
PDP-DIPHENHYDRAMINE 25 MG CAPSULE by Pendopharm
The impurity N-Nitroso-N-Desmethyl Diphenhydramine is out of specification in the affected lots, which is a product…
Carvedilol 25 mg Tablets by Sanis
The impurity N-nitroso-carvedilol may be out of specification in the affected lots of Carvedilol 25 mg…
Automated Impella Controllers (AIC) by Abiomed Inc.
Certain controllers did not receive the FCN 113 updates, which may cause the screen to freeze…
hCG One Step Pregnancy Test Device (Urine/Serum) and hCG One Step Pregnancy Test Strip (Urine) by Innovacon, Inc.
The tests may detect low levels of HCG below the stated assay sensitivity. This may produce…
hCG Cassettes (hCG Combo Cassette 25, hCG Cassette 25) by Abbott Rapid Diagnostics ULC
The cassettes may detect low levels of HCG below the stated assay sensitivity, which may result…
Medline Single Sterile C-Section Drapes W/Incise by Medline Industries, LP
Customers reported that the C-section drapes were difficult to remove from patients. The drapes left adhesive…
CareLink SmartSync Device Manager by Medtronic Inc.
A software error in SmartSync and CareLink for Micra VR2 and Micra AV2 devices can produce…
Medline Sterile Surgical Kits containing Medline C-Section Drape w/Incise by Medline Industries, LP
The C-Section Drape w/Incise in the affected kits may be difficult to remove from patients and…
Glutathione Injection 200 mg/mL, 10 mL multidose vial (compounded) by Greenwich Rx
Injectable products with elevated endotoxin levels could cause significant medical events including fevers, hypotension, inflammatory reactions,…
Medline Convenience Kits Containing Cannula Components with Female Luer Lock Connectors by Medline Industries, LP
The female Luer Lock connectors on the cannula components do not conform to ISO 80369-7 dimensional…
Ethicon Nylon Suture by Ethicon LLC
Some ETHILON Nylon Suture from the recalled lot have needles that are distorted or twisted in…
Radiography 7000 M by Philips Medical Systems DMC GmbH
The drive function of the Radiography 7000 M system (Model 712010) may fail immediately after an…