BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Contamination to in-vitro diagnostic test may result in false positives.
Missing from associated official evidence: action, consumer scope.
Recall archive
Actionable records answer all three decision questions. Limited records remain available and clearly identify missing official information.
Contamination to in-vitro diagnostic test may result in false positives.
Missing from associated official evidence: action, consumer scope.
Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
Missing from associated official evidence: action.
Product has the potential to be contaminated with Salmonella.
Missing from associated official evidence: action.
Product has the potential to be contaminated with Salmonella.
Missing from associated official evidence: action.
Subpotent drug
Missing from associated official evidence: action.
Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss,...
Missing from associated official evidence: action, consumer scope.
Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella.
Missing from associated official evidence: action.
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Missing from associated official evidence: action.
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Missing from associated official evidence: action, consumer scope.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Missing from associated official evidence: action.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Missing from associated official evidence: action.
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Missing from associated official evidence: action.
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Missing from associated official evidence: action.
Undeclared nut allergen (walnut) due to mislabeling. The product's printed tasting guide incorrectly identifies the Walnut Fudge and Peach Cobbler flavor chocolates (bonbons). Consumers relying on the printed materials could mistakenly consume a nut-contain...
Missing from associated official evidence: action.
The potential contamination with Clostridium botulinum, due to risk of temperature abuse during chilled storage at the firm
Missing from associated official evidence: action.
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Missing from associated official evidence: action, consumer scope.
Package integrity compromised.
Missing from associated official evidence: action.
Presence of Particulate Matter.
Missing from associated official evidence: action.
Presence of Particulate Matter.
Missing from associated official evidence: action.
Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms s...
Missing from associated official evidence: action, consumer scope.
Undeclared Milk.
Missing from associated official evidence: action.
Potential contamination with Salmonella.
Missing from associated official evidence: action.
Potential contamination with foreign materials.
Missing from associated official evidence: action.
Chemical contamination; presence of lead and lithium above specification
Missing from associated official evidence: action.