Recall archive
Actionable records answer all three decision questions. Limited records remain available and clearly identify missing official information.
Possible cross-contamination resulting in undeclared allergen ingredient (Peanut)
Missing from associated official evidence: action.
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central...
Missing from associated official evidence: action.
Nitrile Exam Glove failed to meet specifications chemical permeation performance.
Missing from associated official evidence: action, consumer scope.
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
Missing from associated official evidence: action, consumer scope.
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Missing from associated official evidence: action, consumer scope.
Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes because the outer carton and blister pack are labeled as a 1 mL Luer Lock Tuberculin Syringe (Product Code...
Missing from associated official evidence: action, consumer scope.
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
Missing from associated official evidence: action.
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Missing from associated official evidence: action.
Failed Stability Specifications
Missing from associated official evidence: action.
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
Missing from associated official evidence: action.
Undeclared Milk Allergen,
Missing from associated official evidence: action.
The recalled magnetic balls violate the mandatory standard for toys because they are loose high-powered magnets, posing an ingestion hazard to children. When high-powered magnets are swallowed, they can attract each other, or other metal objects, and become...
The sauna's steam diffuser can be positioned too close to a consumer's body, allowing hot steam to come in contact with user, posing a burn hazard.
Consumers can place their fingers in a pinch point, when adjusting the lounge chair, posing an amputation risk.
The power switch on the sofa, loveseat, or recliner can malfunction and overheat posing a risk of serious injury from a fire hazard.
The recalled coin batteries are not in child-resistant packaging and do not bear the warning labels required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns, and...
The recalled toys violate the?mandatory safety standard for toys?because the mini flashlight included with the fidget spinner balls contains button cell batteries that can be easily accessed by children. If button cell or coin batteries are swallowed, the i...
The magnets violate the mandatory safety standard for magnets because the high-powered magnets fit within CPSC's small parts cylinder and are stronger than permitted, posing a deadly ingestion hazard to children. When high-powered magnets are swallowed, the...
The racket sets violate the mandatory standard for toys because the screw on the racket used to secure the battery compartment does not remain attached when opened, and the button cell batteries in the shuttlecock can be easily accessed by children. If butt...
The recalled sauna blankets can overheat, posing fire and burn hazards.
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risk of serious injuries or death to children. The dressers violate the mandatory safety standard as required by the STURDY Act.
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Missing from associated official evidence: action.
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow dr...
Missing from associated official evidence: action, consumer scope.
Failed Impurities/Degradation Specifications
Missing from associated official evidence: action.
