Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
FDA DrugsLevothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6951-61
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6951-61
Subpotent Drug
FDA DevicesOlympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
FDA DevicesMEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.
FDA DevicesMedline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
FDA DevicesThe intended use is to be paired with a weapon for aiming purposes.
The intended use is to be paired with a weapon for aiming purposes.
Wilcox is notifying all customers who have purchased a product from the BOSS Xe family that a software enhancement to increase safety has been released and all units should be returned to implement this change.
FDA DevicesP28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.
P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
FDA DrugsRohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1
Lack of Assurance of Sterility
NHTSAToyota Motor Engineering & Manufacturing - Side Curtain Air Bag May Deploy Improperly
Toyota Motor Engineering & Manufacturing - Side Curtain Air Bag May Deploy Improperly
Improper air bag deployment can increase the risk of injury during a crash.
NHTSAToyota Motor Engineering & Manufacturing - Side Curtain Air Bag May Deploy Improperly
Toyota Motor Engineering & Manufacturing - Side Curtain Air Bag May Deploy Improperly
Improper air bag deployment can increase the risk of injury during a crash.
FDA DevicesFARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
FDA DevicesHalyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.
Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.
Incorrect concentration of Betadine solution contained within certain AVID convenience kits.
FDA FoodMan Fon Inc. Won Ton Wrappers Extra Thin; Net Wt. 10 oz; UPC# 757168 977315, Keep Refrigerated, Can be Frozen. Sold in 48 units (10oz)/case.
Man Fon Inc. Won Ton Wrappers Extra Thin; Net Wt. 10 oz; UPC# 757168 977315, Keep Refrigerated, Can be Frozen. Sold in 48 units (10oz)/case.
Undeclared colors: Yellow#5, and Yellow#6.
USDA FSISFSIS Issues Public Health Alert for Steak Burrito Product Due to Misbranding and Undeclared Allergen
FSIS Issues Public Health Alert for Steak Burrito Product Due to Misbranding and Undeclared Allergen
Misbranding, Unreported Allergens
FDA DrugsLevothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3560-0; NDC Blister: 0904-6951-61
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3560-0; NDC Blister: 0904-6951-61
Subpotent Drug
FDA DrugsLevothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3562-0; NDC Blister: 0904-6951-61
Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3562-0; NDC Blister: 0904-6951-61
Subpotent Drug
FDA DrugsGlycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case).
Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case).
Failed Impurities/Degradation Specifications
NHTSAFord Motor Company - Obstructed Rearview Camera Image/FMVSS 111
Ford Motor Company - Obstructed Rearview Camera Image/FMVSS 111
An obstructed rearview camera image can reduce the driver's rear visibility, increasing the risk of a crash.
NHTSAFord Motor Company - Window Glass Trim Pieces May Detach
Ford Motor Company - Window Glass Trim Pieces May Detach
Detached trim pieces can create a road hazard, increasing the risk of a crash.
NHTSAGrand Design RV, LLC - Incorrectly Secured 120V Outlet May Contact Wiring
Grand Design RV, LLC - Incorrectly Secured 120V Outlet May Contact Wiring
Contact with wiring may cause a short circuit or an electrical arc, increasing the risk of a fire.
NHTSANewell Coach Corp. - Steer Axle Air Springs Base May Crack
Newell Coach Corp. - Steer Axle Air Springs Base May Crack
A cracked base may result in a loss of air pressure and suspension support, increasing the risk of a crash.
NHTSAGrand Design RV, LLC - Incorrect Breaker May Allow Conductor to Overheat
Grand Design RV, LLC - Incorrect Breaker May Allow Conductor to Overheat
An overheated conductor may increase the risk of a fire.
NHTSAGrand Design RV, LLC - Incorrect Tire Pressure Information on Label/FMVSS 120
Grand Design RV, LLC - Incorrect Tire Pressure Information on Label/FMVSS 120
Incorrect tire pressure information can result in over inflated tires, increasing the risk of tire failure and a crash.
NHTSAJayco, Inc. - Incorrect Tire Size on Certification Label
Jayco, Inc. - Incorrect Tire Size on Certification Label
Incorrect information may result in the wrong sized replacement tires being installed, increasing the risk of a crash.
NHTSAPACCAR Incorporated - Oil Contaminated Power Distribution Center/FMVSS 103
PACCAR Incorporated - Oil Contaminated Power Distribution Center/FMVSS 103
A loss of lighting, windshield wipers, ABS function, or a loss of drive power can increase the risk of a crash.