All recalls8,506 total
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini.
The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management.
The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.
Organic Spinach has the potential to be contaminated with Listeria monocytogenes.
Potential contamination with Listeria monocytogenes.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
The nasal feeding tube may be occluded
The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.
There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).
A labeling error was identified on the affected product. The expiration date on the kit box label and on the vial labels incorrectly stated the expiration date as 2026-01-16. The correct expiration date should be 2027-01-17.
There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).
Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
The nasal feeding tube may be occluded
The nasal feeding tube may be occluded
The nasal feeding tube may be occluded
The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.
The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.
Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue causing Malfunction 12: "Pump cannot operate, the mobile app can no longer receive data from the pump. Insulin delivery and any active CGM Sessions have been stopped", which could result in hyperglycemia.
The nasal feeding tube may be occluded
Mozzarella Cheese ingredient potential to be contaminated with metal shavings.
Potential metal fragments from supplier raw material (downstream recall)
Undeclared allergen ingredients (fish, soy, and wheat)
Potential metal fragments from supplier raw material (downstream recall)
Potential presence of foreign material (metal) in the product
Potential metal fragments from supplier raw material (downstream recall)
Potential presence of foreign material (metal) in the product
Potential presence of foreign material (metal) in the product
Potential metal fragments from supplier raw material (downstream recall)
Undeclared sulfites in product label.
Potential metal fragments from supplier raw material (downstream recall)
Potential metal fragments from supplier raw material (downstream recall)
Product contains undeclared egg, FD&C Yellow 5, and FD&C Yellow 6.
Potential metal fragments from supplier raw material (downstream recall)
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout.
Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.
It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for visual verification of device location within the patient s anatomy.
Recall notification from supplier of Potential listeria contamination.
Recall notification from supplier of Potential listeria contamination.
Possible stainless steel pieces in product.