Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
FDA Food1. TNVitamins Ultrapotent Complete Green Superfood Moringa Capsules (120 count) 2. Doctor s Pride Complete Green Superfood Ultra Potent Moringa 10,000 mg (120 capsules)
1. TNVitamins Ultrapotent Complete Green Superfood Moringa Capsules (120 count) 2. Doctor s Pride Complete Green Superfood Ultra Potent Moringa 10,000 mg (120 capsules)
Product may be contaminated with Salmonella.
FDA DevicesNexxZr T Multi A3.5 W98-16mm, REF: 745451
NexxZr T Multi A3.5 W98-16mm, REF: 745451
Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk of fractures under functional stress.
FDA DevicesDigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.
FDA DevicesPlum Duo Precision IV Pump, 40002-0403
Plum Duo Precision IV Pump, 40002-0403
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
FDA FoodTiramisu [image] Cofee Cake The Original, Net Wt. 30 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790850320
Tiramisu [image] Cofee Cake The Original, Net Wt. 30 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790850320
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
FDA FoodCheesecake de Fresa [image] Strawberry Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852843
Cheesecake de Fresa [image] Strawberry Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852843
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
FDA DevicesPlum Duo Infusion Pump, 40002-0401
Plum Duo Infusion Pump, 40002-0401
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
FDA DevicesAllia IGS 5 Pulse angiographic X-ray system
Allia IGS 5 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.
FDA DevicesHintermann Series Talar Implant, Left, Size 2 REF 302112
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.
FDA DevicesProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
FDA DrugsPrimidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
FDA FoodMarquesita de Mango [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852706
Marquesita de Mango [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852706
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
FDA DevicesBrand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
FDA DevicesBoston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Sterile anchors my lack sterility assurance.
FDA FoodFarm Rich Pizza Cheese Crunchers
Farm Rich Pizza Cheese Crunchers
May contain metal pieces
FDA DevicesBrand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays.
Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays.
It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured. The potential clinical hazards include false or missed detection of M-protein (false positive); and falsely elevated or decreased M-protein concentration.
FDA DevicesProduct Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316
Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
FDA DevicesProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
FDA DevicesProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
FDA FoodMarquesita de Dulceleche [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852706
Marquesita de Dulceleche [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852706
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
FDA DevicesMOSAIQ Oncology Information System
MOSAIQ Oncology Information System
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
FDA DevicesBrand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Model/Catalog Number: 1023780 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 52 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave¿ sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A
Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Model/Catalog Number: 1023780 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 52 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave¿ sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A
Due to incorrect incubation process being performed on product.
FDA DevicesAllia IGS 3 Pulse angiographic X-ray system
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.
FDA DevicesProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.