Vereinigte Staaten Recalls
Verbraucherrückrufe von FDA, CPSC, NHTSA und USDA FSIS.
Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
UPC 25081900000 PLATTER PASTRY MINI BREAKFAST 28CT This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
UPC 25081900000 PLATTER PASTRY MINI BREAKFAST 28CT This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
Contains statement does not declare Almond
DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg, 96 Tablets, Distributed by: Drug Mart- Food Fair Medina, OH 44256, UPC: 0 93351 03992 8.
DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg, 96 Tablets, Distributed by: Drug Mart- Food Fair Medina, OH 44256, UPC: 0 93351 03992 8.
Presence of foreign substance: small metallic particles in chewable tablets.
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system
Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.
BD¿Spinal Tray with BD¿Whitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400868, 405652.
BD¿Spinal Tray with BD¿Whitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400868, 405652.
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
UPC 21136500000 Ready Meals BOWL SALMON TERIYAKI SS COLD UPC 21477800000 Ready Meals BOWL TERIYAKI SALMON LARGE SS COLD UPC 21502100000 Ready Meals MEAL SALMON TERIYAKI SS COLD This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
UPC 21136500000 Ready Meals BOWL SALMON TERIYAKI SS COLD UPC 21477800000 Ready Meals BOWL TERIYAKI SALMON LARGE SS COLD UPC 21502100000 Ready Meals MEAL SALMON TERIYAKI SS COLD This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
Contains statement does not declare Salmon
UPC 25811100000 CAKE RASPBERRY MOON 8IN 2-layer. This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
UPC 25811100000 CAKE RASPBERRY MOON 8IN 2-layer. This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
Contains statement does not declare Almond.
UPC 23179700000 SHRIMP KABOB 16-20 CT With JAMAICAN JRK MARINADE This is Albertson's store-made item and sold by random weight at point of sale with grocery store's scale label.
UPC 23179700000 SHRIMP KABOB 16-20 CT With JAMAICAN JRK MARINADE This is Albertson's store-made item and sold by random weight at point of sale with grocery store's scale label.
Contains statement does not declare Shrimp.
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Potential for the Cassette Loading Lever to break.
Atlan A350XL. Model Number: 8621600. anesthesia workstation
Atlan A350XL. Model Number: 8621600. anesthesia workstation
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
UPC 22394700000 Cake Almond Raspberry Pavillions 2-layer This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
UPC 22394700000 Cake Almond Raspberry Pavillions 2-layer This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
Contains statement does not declare Almond.
UPC 25606600000 PARFAIT CUP DUBAI CHOCOLATE This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
UPC 25606600000 PARFAIT CUP DUBAI CHOCOLATE This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
Contains statement does not declare Pistachio
Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050
PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050
The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the product solution and the stainless steel spring and may result in visible discoloration and the presence of trace levels of metallic elements (including iron, chromium, and nickel) in the solution during use.
Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number: 530201 Software Version: N/A Product Description: NES1725KFXL SPINAL EPID CLOSED TIP CATH Component: No
Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number: 530201 Software Version: N/A Product Description: NES1725KFXL SPINAL EPID CLOSED TIP CATH Component: No
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician, Model Numbers 210NDT4 and 210NCL4
Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician, Model Numbers 210NDT4 and 210NCL4
Some of the Calibration/Output Certificates had the outputs reversed.
Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C 20061890 (560074), SSK S C H (560214), SSK BJC H S (ORIGINAL CUST) (560272), SSK CA P M C (ORIGINAL CUST) (560327), SSK T M H (560394), SSK S O 20070208 (560428), SSK L G H (ORIGINAL CUST) (560462), SSK H M H (560465), SSK BUPIVACAINE TRAY 2068824 (560476), SSK K F H (560497), SSK T J U H (560513), SSK O M C (560521), SSK CUSTOM SPINAL TRAY (560523), SSK O R M C (560533), SSK B S H S 20115122 (560538), SSK M M (560572), SSK M S 27GA PENCAN SPINAL TRAY (560580), SSK S T H & C (560584), SSK U C (560587), SSK P25BKG (560603), SSK P24BKG (560606), SSK S25BKG (560607), SSK M C - BUPIVACAINE TRAY (560609), SSK T M C (560613), SSK PENCIL POINT SPINAL TRAY (560619), SSK E O & S H-SPINAL (560621), SSK BSW SPINAL TRAY (560628), SSK M C OB DEPT - SPINAL (560645), SSK B H M (560646), SSK M G M C (560647), SSK S M H (560648), SSK H H S (560660), O S U M C SPINAL TRAY SSK (560667), A M C, SSK (560670), S B H - SPINAL TRAY SSK (560672);
Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C 20061890 (560074), SSK S C H (560214), SSK BJC H S (ORIGINAL CUST) (560272), SSK CA P M C (ORIGINAL CUST) (560327), SSK T M H (560394), SSK S O 20070208 (560428), SSK L G H (ORIGINAL CUST) (560462), SSK H M H (560465), SSK BUPIVACAINE TRAY 2068824 (560476), SSK K F H (560497), SSK T J U H (560513), SSK O M C (560521), SSK CUSTOM SPINAL TRAY (560523), SSK O R M C (560533), SSK B S H S 20115122 (560538), SSK M M (560572), SSK M S 27GA PENCAN SPINAL TRAY (560580), SSK S T H & C (560584), SSK U C (560587), SSK P25BKG (560603), SSK P24BKG (560606), SSK S25BKG (560607), SSK M C - BUPIVACAINE TRAY (560609), SSK T M C (560613), SSK PENCIL POINT SPINAL TRAY (560619), SSK E O & S H-SPINAL (560621), SSK BSW SPINAL TRAY (560628), SSK M C OB DEPT - SPINAL (560645), SSK B H M (560646), SSK M G M C (560647), SSK S M H (560648), SSK H H S (560660), O S U M C SPINAL TRAY SSK (560667), A M C, SSK (560670), S B H - SPINAL TRAY SSK (560672);
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.
UPC 21600500000 READY MEALS SALAD PREMIUM BROCCOLI SS This is Albertson's store-made item and sold by random weight at point of sale with grocery store's scale label.
UPC 21600500000 READY MEALS SALAD PREMIUM BROCCOLI SS This is Albertson's store-made item and sold by random weight at point of sale with grocery store's scale label.
Contains statement does not declare Cashew
UPC 27852000000 Ready Meals BRIE ALMOND TRAY SMALL COLD This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
UPC 27852000000 Ready Meals BRIE ALMOND TRAY SMALL COLD This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
Contains statement does not declare Almond
Betaine Anhydrous, 2055kg, material packed in foil bags inside 15kg cardboard box Label reads in part as "***BETAINE ANHYDROUS 98%***Distributed by Creative Compounds, LLC Scott City, Missouri USA 63780***"
Betaine Anhydrous, 2055kg, material packed in foil bags inside 15kg cardboard box Label reads in part as "***BETAINE ANHYDROUS 98%***Distributed by Creative Compounds, LLC Scott City, Missouri USA 63780***"
Possible carbon steel foreign material (1-2mm)
72% CACAO CHOCOLATE WITH DATE SUGAR WAFERS Ingredients: Cacao Beans, Organic Date Powder, Organic Cocoa Powder Net Wt 25lb (11.3kg) Made in the USA GUITTARD CHOCOLATE COMPANY Burlingame, CA 94010 Item: 0568C25 UPC: 00071818367654
72% CACAO CHOCOLATE WITH DATE SUGAR WAFERS Ingredients: Cacao Beans, Organic Date Powder, Organic Cocoa Powder Net Wt 25lb (11.3kg) Made in the USA GUITTARD CHOCOLATE COMPANY Burlingame, CA 94010 Item: 0568C25 UPC: 00071818367654
Potential contamination with Salmonella
UPC 25216200000 Cheesecake Slice Colossal Dubai. This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
UPC 25216200000 Cheesecake Slice Colossal Dubai. This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
Contains statement does not declare pistachio.
UPC 25800800000 POP DOTS COCO & HAZELNUT 6CT This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
UPC 25800800000 POP DOTS COCO & HAZELNUT 6CT This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
Contains statement does not declare hazelnut