Safety Recalls
RSS ↗15,379 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 12,501–12,550 of 15,379
- Class II
Medical Device Recall · April 17, 2024
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray systemX-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting, 2) the Motor/gear assembly is worn, 3) CAT movement is driven at maximum speed and angulated more than 75 deg. from vertical, and 4) the emergency stop or touch guard is activated during the breaking sequence, which could lead to the C-arm hitting the patient or operator.
- Class II
Medical Device Recall · April 17, 2024
Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10, YSM20R(SV)-1, YSM20R(SV)-2, YSM20R-1, YSM20R-2, YSM20-1, YSM20-2, YSM20W-2, YRM20Non-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 in that they currently do not bear the required certification label.
- Class II
Medical Device Recall · April 17, 2024
CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergenic.Potential contamination of the product with latex adhesive residual.
- Class II
Medical Device Recall · April 17, 2024
Fresenius Medical Care Holdings, Inc.
Blood Pump Rotor, Model Number: F40015481 Rev AAn increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Class II
Food Recall · April 17, 2024
Original Wine Wafer - Lemon Vanilla [Two sizes: retail package of 8 wafers (7 oz) and retail gift package of 2 wafers (2 oz)]Undeclared allergen (milk)
- Class II
Medical Device Recall · April 17, 2024
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Class II
Food Recall · April 17, 2024
California Wine Wafer - Mocha Chocolate and Original Wine Wafer - Mocha Chocolate [Two sizes: retail package of 8 wafers (7 oz) and retail gift package of 2 wafers (2 oz)]Undeclared allergen (milk)
- Class II
Drug Recall · April 17, 2024
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%) Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Gallon Jug 128 fl. oz. (3776 ml), Manufactured for Golden Tiger LLC, Made inOut of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
- Class II
Food Recall · April 17, 2024
Tea Wafer - Vanilla Almond [Two sizes: retail package of 8 wafers (7 oz) and retail gift package of 2 wafers (2 oz)]Undeclared allergen (milk)
- Class II
Medical Device Recall · April 17, 2024
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Class II
Medical Device Recall · April 17, 2024
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.The guide tip can become damaged and result in the tip detaching.
- Class II
Medical Device Recall · April 17, 2024
MEDLINE INDUSTRIES, LP - Northfield
Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10; b) SYRINGE 20ML BLUE L/L LOW PR, Item Number: DYNJSYRPP20B; c) SYRINGE 20ML RED L/L LOW PRESS, IThese syringes were identified to be affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and other quality issues have been identified that may pose a risk to patient health.
- Class II
Medical Device Recall · April 17, 2024
Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-VNon-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 in that they currently do not bear the required certification label.
- Class II
Drug Recall · April 17, 2024
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 4oz (113.39g), painwizard.com Made in the USA, PO BoOut of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
- Class II
Drug Recall · April 17, 2024
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Roll-On NET WT 3 fl. oz. (88.7ml), Manufactured for Golden Tiger USA AlbuquerOut of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
- Class II
Drug Recall · April 17, 2024
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 8 oz (226.79g), Made in the USA, painwizard.com POOut of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
- Class II
Drug Recall · April 17, 2024
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Pump Capsaicin, Aloe Vera, Willow Bark & MSM, Bottle with Pump NET WT 32 fl. oz (946.33ml), Manufactured for Golden TiOut of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
- Class II
Medical Device Recall · April 17, 2024
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Class II
Drug Recall · April 17, 2024
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Tube 4 oz (113.39 g), Mfr. for Golden Tiger USA Albuq, NM, UPC 1 82294 00002Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
- Class II
Food Recall · April 17, 2024
Champagne Wafer - Raspberry Almond [Two sizes: retail package of 8 wafers (7 oz) and retail gift package of 2 wafers (2 oz)]Undeclared allergen (milk)
- Class II
Food Recall · April 17, 2024
Java Wafer - Mocha Hazelnut [Two sizes: retail package of 8 wafers (7 oz) and retail gift package of 2 wafers (2 oz)]Undeclared allergen (milk)
- Class II
Drug Recall · April 17, 2024
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Bottle with pump, NET WT 16 fluid oz / 473.17 ml, Made in USA, wwOut of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
- Class II
Drug Recall · April 17, 2024
ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 4 OZ (113g), Manufactured for AGS BrandOut of Specification for active ingredient
- Class II
Drug Recall · April 17, 2024
ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), Original Formula, SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 1 OZ (28 g), ManufacOut of Specification for active ingredient
- Class II
Medical Device Recall · April 17, 2024
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HNDPotential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
- Class II
Drug Recall · April 17, 2024
Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad Spectrum Sunscreen with UVA/UVB Protection, NEW WT. 5 FL OZ (148ML), Distributed by: Bullfrog Brands LLC, PO BoOut of Specification for active ingredient
- Class II
Drug Recall · April 17, 2024
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Roll-On 3 fl oz (88.7ml), painwizard.com Made in the USA, PO BoxOut of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
- Class II
Medical Device Recall · April 17, 2024
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev AAn increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Class II
Medical Device Recall · April 16, 2024
COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Food Recall · April 16, 2024
La Original Tortilla Co., Inc.
Bulk flour tortillas sold to food service. 20ct 6in flour. 12 packages of 20ct per case. Packed in clear plastic bag and cardboard box.Undeclared ingredients including allergen Wheat
- Class II
Medical Device Recall · April 16, 2024
CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class I
Food Recall · April 16, 2024
Infinite Herbs Organic Basil packed in a clear 2.5 oz, 2.0 oz, and 4 oz PET clamshell container.Salmonella typhimurium in organic basil
- Class II
Medical Device Recall · April 16, 2024
Stryker Blueprint Software, Catalog #BPUE001.The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval.
- Class II
Medical Device Recall · April 16, 2024
COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and aA potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
- Class II
Medical Device Recall · April 16, 2024
EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Food Recall · April 16, 2024
Martinelli's Gold Medal Apple Juice From U.S. Grown Fresh Apples 1 Liter (33.8 fl oz.) No Additives of Any Kind UPC 0 00 41244 00102 6Elevated levels of inorganic arsenic.
- Class II
Medical Device Recall · April 16, 2024
Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.