The print plate artwork for this lot was found to state: Central Line <34 Weeks Kit displaying an incorrect sign in front of the 34. The description for this device should have stated Central Line >34 Weeks Kit. The defect may lead to the product to be used on patient population that is <34 weeks rather than intended population of >34 weeks.
All Recalls
95,114 total recalls in our database
Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex.
PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
Arrow International
the catheter peel-away component hub tabs may prematurely detach. One injury reported.
Iris International is recalling the iChemVELOCITY systems because they do not maintain the on-board strip stability claim of 5 days at 18-28 degrees celsius at 20-80% relative humidity (RH) as stated in the iChemVELOCITY product labeling.
The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.
RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.
RAYSEARCH LABORATORIES AB
Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used. The ROI contraction tool uses six distances as input: right/left, inferior/superior and posterior/anterior. These contraction distances are, in error, pairwise reversed, i.e. right is interpreted as left, inferior is interpreted as superior, and posterior is interpreted as anterior.
Contain 0.1% Benzalkonium Chloride in the 5/8 bandages inside the assortment which is not listed as an active ingredient in the product label.
The device may have improper screw hole placement due to inaccurate location of the index line.
ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructed Radiograph (DRR) for x-ray correction and verification.
Pink Giraffe Animal Purse
Wan Le Xiang Bao Shang hang, of Yiwu, China
The red paint on the zipper contains excessive levels of lead, violating the federal lead paint standard.
Tadpoles Baby and Kids Moses Basket and Stand
Unknown Manufacturer
The Moses basket fails to meet the federal hand-held infant carrier standard and the stand fails to meet the bassinet/cradle standard. The basket can slide off an inclined surface and the stand can tip, posing a fall hazard for infants.
USB Cord & Wall Chargers for iPhone 5/5S
Unknown Manufacturer
The chargers can overheat and catch fire while in use, posing a fire hazard.
Huffy bicycles equipped with front disc brakes
Unknown Manufacturer
An open quick release lever on the bicycle's front wheel hub can come into contact with the front disc brake assembly, causing the front wheel to come to a sudden stop or separate from the bicycle, posing a risk of injury to the rider.
Paintball Markers (Guns)
Unknown Manufacturer
Trigger safety can fail and allow paintballs to fire unexpectedly, posing an impact hazard.
Listeria contamination due to various GMP violations. possible.
Listeria contamination due to various GMP violations. possible.
Listeria contamination due to various GMP violations. possible.
Listeria contamination due to various GMP violations. possible.
Listeria contamination due to various GMP violations. possible.
Listeria contamination due to various GMP violations. possible.