Vereinigte Staaten Recalls
Verbraucherrückrufe von FDA, CPSC, NHTSA und USDA FSIS.
FDA DevicesProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
FDA FoodWeiKFiELD Custard Powder Kesar Pista, Net Wt. 300g (10.6 OZ.), Poly Jar , 24 units per outer case.
WeiKFiELD Custard Powder Kesar Pista, Net Wt. 300g (10.6 OZ.), Poly Jar , 24 units per outer case.
The ingredient, Pista, currently declared on our label should be corrected to the standard American nomenclature, Pistachio.
FDA DevicesProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
FDA FoodJumbo Brazo Gitano Caramelo [image] Jumbo Caramel Roll The Original, Net Wt. 40 oz, packaged in a rigid plastic clamshell container with a transparent dome lid, one unit per container. KEEP REFRIGERATED. UPC 824790852645
Jumbo Brazo Gitano Caramelo [image] Jumbo Caramel Roll The Original, Net Wt. 40 oz, packaged in a rigid plastic clamshell container with a transparent dome lid, one unit per container. KEEP REFRIGERATED. UPC 824790852645
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
FDA FoodJumbo Napolitano [image] Jumbo Neapolitan, Net Wt. 26 oz, packaged in a rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 824790853086
Jumbo Napolitano [image] Jumbo Neapolitan, Net Wt. 26 oz, packaged in a rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 824790853086
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
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 FoodCheesecake de Mango [image] Mango Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852836
Cheesecake de Mango [image] Mango Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852836
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
FDA FoodFlan Cake [image] Custard Cake The Original, Net Wt. 30 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852959
Flan Cake [image] Custard Cake The Original, Net Wt. 30 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852959
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
FDA DevicesCGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
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 DevicesProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
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 FoodCheesecake de Guava [image] Guava Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790853116
Cheesecake de Guava [image] Guava Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790853116
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
FDA FoodNapolitano [image] Neapolitan The Original, Net Wt. 22 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852256
Napolitano [image] Neapolitan The Original, Net Wt. 22 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852256
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
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 DrugsZep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by: Zap Inc., 350 Joe Frank Harris Parkway, SE, Emerson, GA 30137, NDC 66949-133-85.
Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by: Zap Inc., 350 Joe Frank Harris Parkway, SE, Emerson, GA 30137, NDC 66949-133-85.
Microbial contamination of sterile products
FDA DevicesFresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100
Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100
A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument model number BENCH R-100 which could under very rare specific misuse circumstances potentially allow human access to infrared laser light levels in excess of the safety Classification of the product.
FDA FoodESTRELLA, Bebida de Parcha (Passion Fruit Drink), multiple sizes, 14 OZ.FL. (413 ML), 64 OZ.FL (1,920mL), 120 OZ.FL. (3.54LT.) 14 OZ.FL Plastic Bottles packed in cases of 25 bottles. KEEP REFRIGIRATED.
ESTRELLA, Bebida de Parcha (Passion Fruit Drink), multiple sizes, 14 OZ.FL. (413 ML), 64 OZ.FL (1,920mL), 120 OZ.FL. (3.54LT.) 14 OZ.FL Plastic Bottles packed in cases of 25 bottles. KEEP REFRIGIRATED.
Undeclared FD&C Red 40
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: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
FDA DevicesAdvance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains different first aid instructions, most critically in that the Ferric Sulfate insert instructs users to induce vomiting in the case of ingestion, while the correct Aluminum Chloride insert instructs users not to induce vomiting.
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 DevicesMerlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
FDA DevicesAllia IGS Pulse angiographic X-ray system
Allia IGS 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.