All recalls8,424 total
Product tested positive for Listeria Monocytogenes.
Potential contamination with leachable lead.
Product tested positive for Listeria Monocytogenes.
The products contain an unallowed color Carmoisine (E122) - Acid Red 14.
Potential contamination with leachable lead.
Potential contamination with leachable lead.
Product tested positive for Listeria Monocytogenes.
The products contain an unallowed color Carmoisine (E122) - Acid Red 14.
Product tested positive for Listeria Monocytogenes.
The products contain an unallowed color Carmoisine (E122) - Acid Red 14.
Product tested positive for Listeria Monocytogenes.
Product tested positive for Listeria Monocytogenes.
Product tested positive for Listeria Monocytogenes.
Product tested positive for Listeria Monocytogenes.
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Emphasizing instructions for LVP duration programming located in the IFU.
Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.
Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of breath leading to hypoxia, which may require medical intervention to prevent further respiratory deterioration.
Product may be contaminated with Salmonella
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Incorrect Product Formulation
Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or delay in accessing stored items, delay in the replenishment of ADCs or patient specific medications stored outside of ADCs.
Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.
Products found to contain leachable lead levels (3.00 mg/L)
Products found to contain leachable lead levels (0.323mg/L)
Product tested high for lead.
Product tested high for lead.
Undeclared allergen ingredient (wheat).
Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
Plastic fragments. Pieces of semi-rigid plastic embedded in the recalled Tater Gems product.
partially hydrogenated oils (PHOs) in foods exported to the US
partially hydrogenated oils (PHOs) in foods exported to the US
Cross Contamination with Other Products
Recalled lots were manufactured with double the amount of preservative concentration.
When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.
It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.
Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar reconstruction applied; Manual rotation applied, could result in inaccurate length measurement tool values that could compromise diagnostic accuracy, lead to misdiagnosis or inappropriate follow-up.
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.
A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment.