Safety Recalls
RSS ↗15,364 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 10,501–10,550 of 15,364
- Class II
Medical Device Recall · August 15, 2024
STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095WIncomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
- Class II
Food Recall · August 15, 2024
Great Value; 8oz Apple Juice in 6 pack; 100% Juice; packaged in 8 oz. PET plastic bottles; UPC 0-78742-29655-5Product contains inorganic arsenic above action level set in industry guidance (13.2ppb)
- Class II
Medical Device Recall · August 15, 2024
Alaris Syringe Module Model 8110, a modular infusion pump and monitoring systemDue to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
- Unclassified
Consumer Product Recall · August 15, 2024
Hangzhoumeixiajianzhushejiyouxiangongs D/B/A MEIXIA Shop, of China
Mamibaby and Cosy Nation Baby LoungersThe recalled baby loungers violate the federal safety regulations for Infant Sleep Products because the sides are too low to contain the infant; the sleeping pad is too thick, posing a suffocation hazard; an infant could fall out of an enclosed opening at the foot of the lounger or become entrapped; and the loungers do not have a stand, posing a fall hazard if used on elevated surfaces. These violations create an unsafe sleeping environment for infants.
- Unclassified
Consumer Product Recall · August 15, 2024
Stanley Black and Decker Inc., of New Britain, Connecticut
DeWALT Battery Push walk-behind mowers and DeWALT Battery Self-Propelled walk-behind mowersIf water gets into the mower's handle support while the battery is installed, the mower can fail to shut off when the bail handle is released or start without a key, posing a laceration hazard to the user.
- Class II
Medical Device Recall · August 15, 2024
STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
- Class II
Medical Device Recall · August 15, 2024
STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095LIncomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
- Class II
Medical Device Recall · August 15, 2024
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095DAIncomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
- Class II
Medical Device Recall · August 15, 2024
SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
- Class II
Medical Device Recall · August 15, 2024
Alaris PCA Module Model 8120, a modular infusion pump and monitoring systemDue to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
- Class III
Drug Recall · August 15, 2024
Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer Unit, 1 manometer tubing, Rx Only, Distributed by BiocompatiblDefective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).
- Class II
Medical Device Recall · August 15, 2024
Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring systemDue to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
- Class II
Medical Device Recall · August 15, 2024
STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096AIncomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
- Class II
Medical Device Recall · August 15, 2024
Siemens Medical Solutions USA, Inc.
ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software.If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management
- Class II
Medical Device Recall · August 15, 2024
Roche Diagnostics Operations, Inc.
Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. Catalog Number: 0719079Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and misdiagnosis.
- Class II
Medical Device Recall · August 15, 2024
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring systemDue to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
- Unclassified
Consumer Product Recall · August 15, 2024
IKEA Supply AG, of Switzerland
VARMFRONT Power BanksThe power banks can overheat, posing a fire hazard.
- Class II
Drug Recall · August 15, 2024
Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, KS 57226.Lack of Assurance of Sterility
- Class II
Medical Device Recall · August 15, 2024
Alaris Pump Module Model 8100, a modular infusion pump and monitoring systemDue to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
- Class II
Medical Device Recall · August 15, 2024
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095DIncomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
- Class II
Medical Device Recall · August 15, 2024
Siemens Medical Solutions USA, Inc.
ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, with softwareIf ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management
- Class II
Medical Device Recall · August 15, 2024
Siemens Medical Solutions USA, Inc.
ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with softwareIf ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management
- Class II
Medical Device Recall · August 15, 2024
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers.Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated in the Instructions for Use (IFU) on the Atellica CH, Atellica CI Analyzers, ADVIA 1800 Chemistry Systems, ADVIA 2400 Chemistry Systems, and ADVIA Chemistry XPT Systems, may result in erroneously depressed microalbumin patient results.
- Unclassified
Consumer Product Recall · August 15, 2024
ALDI Inc., of Batavia, Illinois
Ambiano Single Serve Coffee MakersThe recalled coffee makers can expel hot water from the top of the machine, posing a burn hazard.
- Unclassified
Consumer Product Recall · August 15, 2024
Lypometal Sdn. Bhd., of Malaysia (Sunjoy Group)
Berkley Jensen GazebosThe gazebo's roof panels can dislodge in high winds, posing an injury hazard.
- Unclassified
Consumer Product Recall · August 15, 2024
Trader Joe's Company, of Monrovia, California
Mango Tangerine Scented CandlesThe candle flame can spread from the wick to the wax causing a larger than expected flame, posing a fire hazard.
- Class II
Medical Device Recall · August 14, 2024
3M Company - Health Care Business
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658RContamination with foreign substance matter
- Class II
Medical Device Recall · August 14, 2024
TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using boneDue to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
- Class II
Food Recall · August 14, 2024
Montreal Fudge brand Chocolate Fudge with Nuts; 5.6ozProduct may be contaminated with mold.
- Class II
Food Recall · August 14, 2024
NOW Real Foods Whole & Unsalted Raw Brazil Nuts 12oz. bag UPC 733739070128High mold, yeast, and total viable count
- Class II
Medical Device Recall · August 13, 2024
Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life.
- Class II
Medical Device Recall · August 13, 2024
Olympus Corporation of the Americas
Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue Model/Catalog Number: TFL-SLSThe term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.
- Class II
Medical Device Recall · August 13, 2024
Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life.
- Class II
Medical Device Recall · August 13, 2024
Olympus Corporation of the Americas
Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLSThe term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.
- Class II
Medical Device Recall · August 12, 2024
Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and analysis. The Seer Home System includes the Sight MonDuring CAPA investigations of sight production inconsistencies, it was highlighted that previous Electromagnetic Compatibility (EMC) assessments related to RF radiated emissions may not be reasonably equivalent to the current product due to design changes in the system. A new CAPA was opened to investigate the radiated emissions compliance issues. - Seer Home Systems distributed and retained in the field were not compliant with Electromagnetic Compatibility (EMC) testing according to IEC 60601-1-2 - Seer Home Systems, including accessories, were manufactured and distributed without application of proper design change and manufacturing controls - Seer Home Systems were distributed with labeling deficiencies
- Class II
Medical Device Recall · August 12, 2024
ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
- Class II
Food Recall · August 12, 2024
6.5oz Emerald Kettle Glazed Walnut, UPC: 0 10300 80894 7undeclared peanuts, almonds and pecans
- Class II
Drug Recall · August 12, 2024
Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, DiDefective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
- Class II
Medical Device Recall · August 12, 2024
Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)7F sheath introducers labeled as 7.5F
- Class II
Medical Device Recall · August 12, 2024
Custom Procedure Kit, REF: K12T-110777F sheath introducers labeled as 7.5F
- Class II
Medical Device Recall · August 12, 2024
ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
- Class II
Medical Device Recall · August 12, 2024
Becton, Dickinson and Company, BD Bio Sciences
BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare humanSample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube assay: Specimen volume dispensed into tube1 at least 3% higher than volume in tube2, or 2) Absolute counts calculated using Trucount Tubes: increased volume in tube1 may result in 20% higher absolute counts in tube 1 than tube 2; could result in additional blood collection, delayed results/patient therapy.
- Unclassified
Vehicle Recall · August 11, 2024
2023 DYNAMAX ISATA, 2023 FOREST RIVER SUNSEEKER, 2023 FOREST RIVER GEORGETOWN, 2024 EAST TO WEST ENTRADA, 2024 FOREST RIVER FR3, 2024 FOREST RIVER GEORGETOWN, 2025 FOREST RIVER GEORGETOWNAn air conditioner soft start device that overheats increases the risk of a fire.
- Unclassified
Vehicle Recall · August 11, 2024
2023 FORD ESCAPE, 2023 FORD EXPEDITION, 2023 FORD EXPLORER, 2023 LINCOLN AVIATOR, 2023 LINCOLN CORSAIR, 2023 LINCOLN NAVIGATOR, 2024 FORD ESCAPE, 2024 FORD EXPEDITION, 2024 FORD EXPLORER, 2024 LINCOLNWithout a label that shows the proper restraint usage guidelines, the occupants may have an increased risk of injury in the event of a crash.
- Unclassified
Vehicle Recall · August 11, 2024
2024 FORD ESCAPEDuring air bag deployment, the air bag cover may break and project fragments into the vehicle, or the air bag may deploy improperly, increasing the risk of occupant injury.
- Class II
Drug Recall · August 9, 2024
Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport,Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
- Class II
Medical Device Recall · August 9, 2024
Wipro GE Healthcare Private Ltd.
GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physioloGE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protections included in the product design. However, because the electrical safety testing in manufacturing was incomplete for these devices, there is the potential for leakage current to exceed IEC 60601 limits.
- Class I
Food Recall · August 9, 2024
Prime Food brand Steam Bun with Egg Custard Added; 10pcs/pack; NET WT. 20 oz (1lb.4 oz) 568g; KEEP FROZEN; INGREDIENTS: Dough: Bleached Wheat Flour, Water, Sugar, Salad Oil (Soybean Oil, Canola Oil),Products may contain undeclared sesame
- Class II
Medical Device Recall · August 9, 2024
Vios Monitoring System Bedside Monitor Model BSM2050Batteries may deplete over time while not in use if devices are stored without being plugged in to wall outlet. Depleted batteries may lead to tablet connectivity issues.
- Class I
Food Recall · August 9, 2024
Prime Food brand Steam Bun with Egg Custard & Coconut Added; 10pcs/pack; NET WT. 20 oz (1lb.4 oz) 568g; KEEP FROZEN; INGREDIENTS: Dough: Bleached Wheat Flour, Water, Sugar, Salad Oil (Soybean Oil, CanProducts may contain undeclared sesame