All recalls7,819 total
Potential contamination with Salmonella.
Potential contamination with leachable lead.
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.