Recall archive
Actionable records answer all three decision questions. Limited records remain available and clearly identify missing official information.
Product contains undeclared Yellow No. 5.
Missing from associated official evidence: action.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Missing from associated official evidence: action, consumer scope.
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Missing from associated official evidence: action.
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years...
Missing from associated official evidence: action, consumer scope.
insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin...
Missing from associated official evidence: action, consumer scope.
cGMP deviations.
Missing from associated official evidence: action.
Undeclared food colorings (Yellow 6, Blue 1, and Yellow 5) and unapproved Acid Red 14.
Missing from associated official evidence: action.
Labeling: Missing Label
Missing from associated official evidence: action.
Failed PH Specifications
Missing from associated official evidence: action.
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a co...
Missing from associated official evidence: action, consumer scope.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Missing from associated official evidence: action, consumer scope.
Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D)...
Missing from associated official evidence: action.
Foreign object found inside retail container.
Missing from associated official evidence: action.
Contains undeclared FD&C Yellow 6
Missing from associated official evidence: action.
Lack of Assurance of Sterility
Missing from associated official evidence: action.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Missing from associated official evidence: action, consumer scope.
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Missing from associated official evidence: action.
Product may contain foreign objects, specifically glass.
Missing from associated official evidence: action.
Undeclared allergen (almond).
Missing from associated official evidence: action.
There is a possibility of reagent leakage from the specimen container.
Missing from associated official evidence: action, consumer scope.
Cyber vulnerability of BLE communication was found by CISA VDP program.
Missing from associated official evidence: action.
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standard as required by the STURDY Act.
The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiat...
The pre-filled fuel containers violate the mandatory safety standards for portable fuel containers because they lack flame mitigation devices required under the Portable Fuel Container Safety Act, posing a deadly risk of flash fire. In addition, the Childre...
