Complete FDA and NHTSA recall records dated in September 2018.
These records include useful source details for the selected month.
Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
Multiple surgical packs were assembled with a non-sterile CHG applicators labeled as "ChloraPrep" (kit component numbers: 29183, 52115, 82279, and 82281). The non-sterile components 29183,…
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
The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled sterile (kit component #80532NS). The non-sterile component 80532NS was supposed to be placed…
Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.
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…
There is the potential for a scenario where a punctured cup of sterilant expires while the system is powered down, upon power-up the unit will not detect the expired cup of sterilant;…
The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
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…
Complete delivery System (CDS) # CDS984746C was assembled using a non-sterile cardiac insulation pad, Medline component number 32369. The non-sterile component (32369) was placed within the…
Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals.
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.
It was found when an operator performs a radiography using the wireless flat panel detector (FPD), a message window was displayed on the monitor stating image transmission was not completed…
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…
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…
Incorrect use-by date on the device registration/patient file labels.
The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
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.
After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
