💊 Drugs Class I - Dangerous
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
All Recalls
95,018 total recalls in our database
Medicina Oral Tip Syringe 0.5ml Code: OT005
Medicina Uk
🏥 Medical Devices Class I - Dangerous
Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
🏥 Medical Devices Class I - Dangerous
Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Dimension Vista¿ High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an Abnormal Reaction [E145]: flag, a falsely depressed or elevated result ranging from -90% to 133% may be observed.
Medicina Oral Tip Syringe 2.5ml Code: OT25
Medicina Uk
🏥 Medical Devices Class I - Dangerous
Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
🏥 Medical Devices Class I - Dangerous
Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming volumes and kit contents for product code ASK-41552-JHVA1), instead of the packaged single-lumen 4.5 French catheter (and related priming volumes and kit contents for product code ASK-41541-JHVA1).
🏥 Medical Devices Class I - Dangerous
Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lead to inappropriate dosage adjustment, potentially affecting treatment efficacy.
N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
SIEMENS HEALTHCARE DIAGNOSTICS
🏥 Medical Devices Class I - Dangerous
N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
SIEMENS HEALTHCARE DIAGNOSTICS
🏥 Medical Devices Class I - Dangerous
N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).
🏥 Medical Devices Class I - Dangerous
Incidents of device splitting or detaching during use
🏥 Medical Devices Class I - Dangerous
An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.
CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
One lot of chest tube insertion trays, containing a silk suture component that is restricted to 1 cycle of sterilization, was processed though 2 cycles.
Medicina Reusable Oral syringe 5ml Code: OTH05
Medicina Uk
🏥 Medical Devices Class I - Dangerous
Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
🏥 Medical Devices Class I - Dangerous
Incidents of device splitting or detaching during use
Medicina Oral Tip Syringe 1ml Code: OT01
Medicina Uk
🏥 Medical Devices Class I - Dangerous
Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
🏥 Medical Devices Class I - Dangerous
Incidents of device splitting or detaching during use
Medicina Reusable Oral syringe 2.5ml Code: OTH25
Medicina Uk
🏥 Medical Devices Class I - Dangerous
Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
Synthes (USA) Products
🏥 Medical Devices Class I - Dangerous
The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.
Roche Molecular Systems
🏥 Medical Devices Class I - Dangerous
Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.