Recall archive
Actionable records answer all three decision questions. Limited records remain available and clearly identify missing official information.
Failed Dissolution Specifications
Missing from associated official evidence: action.
Potential for overpressure alerts.
Missing from associated official evidence: action, consumer scope.
Potential for Salmonella
Missing from associated official evidence: action.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable pro...
Missing from associated official evidence: action.
Defective container:may contain bottles with incomplete seals
Missing from associated official evidence: action.
Product requires refrigeration but the label is missing a "Keep Refrigerated" statement
Missing from associated official evidence: action.
Labeling: Incorrect or Missing Lot and/or Exp Date
Missing from associated official evidence: action.
GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. I...
Missing from associated official evidence: action, consumer scope.
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
Missing from associated official evidence: action.
Firm observed oily and sticky substance on direct food contact surface packaging of finished product.
Missing from associated official evidence: action.
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Missing from associated official evidence: action, consumer scope.
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
Missing from associated official evidence: action, consumer scope.
Product tested positive for Salmonella
Missing from associated official evidence: action.
CGMP Deviations; deficiencies observed during FDA inspection
Missing from associated official evidence: action.
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Missing from associated official evidence: action, consumer scope.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from th...
Missing from associated official evidence: action, consumer scope.
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
Missing from associated official evidence: action, consumer scope.
The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.
Missing from associated official evidence: action, consumer scope.
Undeclared Allergen (Soy)
Missing from associated official evidence: action.
Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
Missing from associated official evidence: action, consumer scope.
Plain salt was labeled as iodized and iodized salt was labeled as plain.
Missing from associated official evidence: action.
Due to unsealed portions of pouches.
Missing from associated official evidence: action, consumer scope.
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled a...
Missing from associated official evidence: action, consumer scope.
Subpotent Drug
Missing from associated official evidence: action.
