United States Recalls
Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit ...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Allia IGS 3 Pulse angiographic X-ray system
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-d...
Presence of Particulate matter: Particulate matter identified as glass.
Napolitano [image] Neapolitan The Original, Net Wt. 22 oz, packaged in a transpa...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
ESTRELLA, Bebida de Parcha (Passion Fruit Drink), multiple sizes, 14 OZ.FL. (41...
Undeclared FD&C Red 40
NEURO NOURISH dietary supplement; 6-IN-1 PREBIOTIC, PROBIOTIC, VITAMIN, MINERAL,...
Premature lipid oxidation causing quality issue potentially causing product to have an off odor and bitter taste.
Cake de Guayaba [image] Guava Cake The Original, Net Wt. 47 oz, packaged in a pl...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
MOSAIQ Oncology Information System
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle...
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Cake de Mango [image] Mango Cake The Original, Net Wt. 47 oz, packaged in a rigi...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; ...
Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.
Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPO...
Due to incorrect incubation process being performed on product.
Individual Unit Label (both lid and front of cup): Whole Foods Market Kitchens M...
Contains undeclared allergen (shrimp).
BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propo...
Microbial Contamination of Non-Sterile Products
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Sterile anchors my lack sterility assurance.
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUS...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Cheesecake de Guava [image] Guava Cheesecake The Original, Net Wt. 26 oz, packag...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Hintermann Series Talar Implant, Left, Size 2 REF 302112
Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.
Allia Moveo angiographic X-ray system
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
Halyard, Pain Pack. Kit Code: AMPK48-01.
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Cake de Capuchino [image] Capuchino Cake The Original, Net Wt. 63 oz, packaged i...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
DRAGONFLY Thai Ginger Powder Net Weight: 4.37 oz (125 g) PRODUCT OF THAILAND Pa...
Potential contamination with lead.
Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23,...
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.