Vereinigte Staaten Recalls
Verbraucherrückrufe von FDA, CPSC, NHTSA und USDA FSIS.
CPSCTarget Recalls Gigglescape™ Under the Sea Popping Toy Due to Choking Hazard
Target Recalls Gigglescape™ Under the Sea Popping Toy Due to Choking Hazard
The clear plastic dome can detach from the blue plastic base, making the small plastic balls inside the toy accessible to children, posing a choking hazard.
CPSCConair Recalls Over One Million Cuisinart Grill Brushes Due to Ingestion Hazard
Conair Recalls Over One Million Cuisinart Grill Brushes Due to Ingestion Hazard
Small metal wire bristles can detach from the brushes and stick to the grill or food, posing an ingestion hazard and risk of serious internal injuries that could require surgery.
CPSCWinco Fireworks International Recalls Unity 7 Shot 200 Gram Aerial Cake Fireworks Due to Risk of Serious Injury from Explosion and Burn Hazards
Winco Fireworks International Recalls Unity 7 Shot 200 Gram Aerial Cake Fireworks Due to Risk of Serious Injury from Explosion and Burn Hazards
The recalled fireworks can tip over, posing a risk of serious injury from explosion and burn hazards.
NHTSAAltec Industries, Inc. - Incorrectly Routed Inverter AC Wiring May Short and Overheat
Altec Industries, Inc. - Incorrectly Routed Inverter AC Wiring May Short and Overheat
A short may cause the inverter AC wiring to overheat, increasing the risk of a fire.
NHTSAWARN Industries, Inc. - Wireless Remote May Fail to Stop Winch
WARN Industries, Inc. - Wireless Remote May Fail to Stop Winch
A winch that operates unintentionally may increase the risk of injury.
NHTSAJayco, Inc. - Grounding Connection Not Installed
Jayco, Inc. - Grounding Connection Not Installed
The electrical system may overheat without a ground, increasing the risk of a fire. There is also an increased risk of injury from electrical shock.
NHTSANissan North America, Inc. - Rear Seat Belts May Not Secure Child Seat/FMVSS 208
Nissan North America, Inc. - Rear Seat Belts May Not Secure Child Seat/FMVSS 208
An improperly secured child restraint system may not restrain an occupant as intended, increasing the risk of injury during a crash.
NHTSAHyundai Motor America - Park Outside: High Voltage Battery May Catch Fire
Hyundai Motor America - Park Outside: High Voltage Battery May Catch Fire
A fire increases the risk of injury.
NHTSAKia America, Inc. - Park Outside: High Voltage Battery May Catch Fire
Kia America, Inc. - Park Outside: High Voltage Battery May Catch Fire
A fire increases the risk of injury.
NHTSAKia America, Inc. - Park Outside: Fire from Overheated Power Seat Motors
Kia America, Inc. - Park Outside: Fire from Overheated Power Seat Motors
A fire increases the risk of injury.
NHTSAJayco, Inc. - Grounding Connection Not Installed
Jayco, Inc. - Grounding Connection Not Installed
The electrical system may overheat without a ground, increasing the risk of a fire. There is also an increased risk of injury from electrical shock.
FDA FoodPearl Milling Company Original Pancake & Waffle Mix Complete (Mezcla Para Panqueques y Waffles) Net Wt 5.99 oz (170 g). Packed in 50 - 5.99 oz BOPP Pouch units per master case. Keep in a cool, dry place.
Pearl Milling Company Original Pancake & Waffle Mix Complete (Mezcla Para Panqueques y Waffles) Net Wt 5.99 oz (170 g). Packed in 50 - 5.99 oz BOPP Pouch units per master case. Keep in a cool, dry place.
Undeclared allergens: Milk and Soy
FDA DrugsCorlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60
Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60
Presence of Foreign Substance.
FDA DevicesOctopus 4 Tissue Stabilizer, Model 29400
Octopus 4 Tissue Stabilizer, Model 29400
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
FDA DevicesSurgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
FDA DevicesAbiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
Potential for thrombus formation during prolonged use of the introducer.
FDA FoodJoy Mango-Pina-Strawberry Lassi 16 oz.
Joy Mango-Pina-Strawberry Lassi 16 oz.
Product not adequately pasteurized
FDA FoodJoy Pineapple Lassi 16 oz.
Joy Pineapple Lassi 16 oz.
Product not adequately pasteurized
FDA DrugsSensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30
Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30
CGMP Deviations
FDA FoodSpring & Mulberry Mulberry Fennel Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a burgundy box, UPC 850055470149, Dist. By Spring & Mulberry Raleigh, NC 27606. Wholesale product packed 48 bars (caddied)/56 bars (uncaddied) per case. Retail product sold individually or as a 3-pk, 6-pk, or 12-pk (Amazon only).
Spring & Mulberry Mulberry Fennel Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a burgundy box, UPC 850055470149, Dist. By Spring & Mulberry Raleigh, NC 27606. Wholesale product packed 48 bars (caddied)/56 bars (uncaddied) per case. Retail product sold individually or as a 3-pk, 6-pk, or 12-pk (Amazon only).
Potential Salmonella contamination.
FDA Food2.0 oz Dirty Maui Onion Chip, Plastic Bag.
2.0 oz Dirty Maui Onion Chip, Plastic Bag.
Potential presence of Salmonella.
FDA DevicesConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. AAA DYNJ905651B ARTERIOGRAM TRAY 00-402001S AV SHUNT PACK-LF DYNJ0842516F BASIC IR PACK-LF PHS463660F CATH PROCEDURAL TRAY DYNJ43580C CONGENITAL ADD-ON KIT DYNDA2213A CUSTOM PROCEDURE KIT DYNJ65277A DEEP BRAIN STIMULATION PACK DYNJ0842793F HOSPITAL REGIONAL DE CONCEPCIO DYNJ67918 INTERVENTIONAL PACK DYNJ56666B INVASIVE LINE INSERTION DYNJ44123A JUDKINS PACK DYNJ51126B LARKIN CUSTOM NEURO TRAY PAIN1454 MAJOR PLUS PACK DYNJ905160I MINIMALLY INVASIVE PACK-LF DYNJ0843063J NEURO ANGIO PACK SJF-LF DYNJ37304F NON-VASCULAR PACK DYNJ56386B OR HYBRID-MRMC DYNJ907758 PACER PACK DYNJ40952 PAIN PACK DYNJ60715 PICC PHC DYNJ37484B ROBOTIC PACK DYNJ908706A THORACOTOMY PACK-LF DYNJ0101339J DYNJ69090 VENOUS PACK DYNJ56260B
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. AAA DYNJ905651B ARTERIOGRAM TRAY 00-402001S AV SHUNT PACK-LF DYNJ0842516F BASIC IR PACK-LF PHS463660F CATH PROCEDURAL TRAY DYNJ43580C CONGENITAL ADD-ON KIT DYNDA2213A CUSTOM PROCEDURE KIT DYNJ65277A DEEP BRAIN STIMULATION PACK DYNJ0842793F HOSPITAL REGIONAL DE CONCEPCIO DYNJ67918 INTERVENTIONAL PACK DYNJ56666B INVASIVE LINE INSERTION DYNJ44123A JUDKINS PACK DYNJ51126B LARKIN CUSTOM NEURO TRAY PAIN1454 MAJOR PLUS PACK DYNJ905160I MINIMALLY INVASIVE PACK-LF DYNJ0843063J NEURO ANGIO PACK SJF-LF DYNJ37304F NON-VASCULAR PACK DYNJ56386B OR HYBRID-MRMC DYNJ907758 PACER PACK DYNJ40952 PAIN PACK DYNJ60715 PICC PHC DYNJ37484B ROBOTIC PACK DYNJ908706A THORACOTOMY PACK-LF DYNJ0101339J DYNJ69090 VENOUS PACK DYNJ56260B
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
FDA DrugsDULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.
DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
FDA FoodJoy Orange Lassi 16 oz.
Joy Orange Lassi 16 oz.
Product not adequately pasteurized