95,064 total recalls in our database
Avkare Incorporated
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
Avkare Incorporated
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Avkare Incorporated
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Supterpotent Drug
The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
Hitachi Healthcare Americas Corp Informatics Division
The secure filesystem client software used in the interface between the Vidistar PACS and an EHR system may cause intermixed images from multiple patients showing in a single study.
The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of bolts may compromise the structural integrity of the system which could lead to the OCS disengaging from the ceiling mount and this may cause injury to the patient or the operator.
PerkinElmer Life and Analytical Sciences, Wallac, OY
The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information required to assess the acceptability of measured control values which may result in a delay in reporting IRT results.
A size 22mm threaded peg was found in the package of a 10mm unit.
Quasar Bio-Tech
Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.
Vials labeled for the prescriptions contained incorrect lenses
Medline Industries
Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit component #52655) attached to the outside of the sterile pack. This may pose potential risk of infection. However, the kits have been in distribution since March 2016. Many of these kits have been used with no reported infections or adverse patient events. In addition, the BIOPATCH is impregnated with CHG, a well-known antiseptic agent with broad-spectrum anti-microbial and antifungal activity.
After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.
Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling.
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
Incorrect use-by date on the device registration/patient file labels.
Medline Industries
Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit component #52655) attached to the outside of the sterile pack. This may pose potential risk of infection. However, the kits have been in distribution since March 2016. Many of these kits have been used with no reported infections or adverse patient events. In addition, the BIOPATCH is impregnated with CHG, a well-known antiseptic agent with broad-spectrum anti-microbial and antifungal activity.
Exactech
Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on the device is incorrect. The GTIN on the device reads 10885862525629, when it should read 10885862525628.