95,018 total recalls in our database
Aurobindo Pharma USA
Failed Impurities/Degradation Specifications
cGMP Deviations
ABC Sales 1
Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.
Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
The firm received reports indicating PTD tip separation during use.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.
The firm received reports indicating PTD tip separation during use.
Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner label stating the product is Catalog #0919K Haemophilus influenza. The organism has been confirmed to be C. coli, indicating this is a labeling error and the organism is the correct organism.
The firm received reports indicating PTD tip separation during use.
Missing bushing on Liko M220 and M230 causing wear and potential for patient falling
Potential cessation in ventilation can occur under specific conditions.
The firm received reports indicating PTD tip separation during use.
Howmedica Osteonics
There is a potential for the outer Tyvek lid to de-bond from the sealed package.
Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin
The product does not have 510(k) clearance.
There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.
Merete Medical GmbH
Incorrect marketing label (25 mm) was applied to product size 20 mm.
Olympus Corporation of the Americas
The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent will be dispensed instead of alcohol for the alcohol cycle, resulting in a ineffective endoscope reprocessing and patient exposure to residual detergent