Safety Recalls
RSS ↗15,379 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 14,251–14,300 of 15,379
- Class II
Medical Device Recall · January 3, 2024
Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and oDiscoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location of the delivery pusher within the delivery system, it is possible for the discoloration to mechanically break off from the delivery pusher, leaving the potential for the material to flow through the delivery system (i.e. microcatheter), and into the patient vasculature causing foreign emboli.
- Class II
Medical Device Recall · January 3, 2024
Intera Achieva 1.5T Pulsar. Model (REF) Number 781171.The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
- Class II
Medical Device Recall · January 3, 2024
Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
- Class I
Medical Device Recall · January 3, 2024
1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch ApplicationDue to software and controller systems that results in unexpected pump start or pump stop.
- Unclassified
Vehicle Recall · January 3, 2024
2023 KIA STINGERAn oil leak in the presence of hot engine components can increase the risk of an engine compartment fire while driving.
- Class II
Medical Device Recall · January 3, 2024
Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.The incorrect device is contained in the labeled package.
- Class II
Medical Device Recall · January 3, 2024
FUJIFILM Healthcare Americas Corporation
Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the processing of medical images.The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting in long-term health consequences or serious deterioration of health.
- Class II
Medical Device Recall · January 3, 2024
Achieva XR. Model (REF) Numbers 781153, 781253.The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
- Class II
Medical Device Recall · January 3, 2024
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrumentA software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.
- Class II
Medical Device Recall · January 3, 2024
FUJIFILM Healthcare Americas Corporation
Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting in long-term health consequences or serious deterioration of health.
- Class II
Medical Device Recall · January 3, 2024
USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125, PE25151113 - 13X125mm, PE25151115 - 15X125mm, PE2Their is a potential that the implant curved stem may be oriented incorrectly.
- Class II
Medical Device Recall · January 3, 2024
Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345.The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
- Class II
Medical Device Recall · January 3, 2024
Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261.The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
- Unclassified
Vehicle Recall · January 2, 2024
2023 TIFFIN ALLEGRO BAY, 2024 TIFFIN ALLEGRO BAYBattery terminals that contact the steel hold-down bar can cause electrical arcing and increase the risk of a fire.
- Unclassified
Vehicle Recall · January 2, 2024
2023 ENTEGRA REATTA XLA loose or detached seat assembly increases the risk of injury.
- Class II
Food Recall · January 2, 2024
Vandevi Compounded Asafoetida 50 gm, 100 gms 200 gm, 500 gm, 1 kg. Packaged in yellow plastic bottles with plastic shrink wrap blue/yellow labels.Undeclared wheat
- Class II
Medical Device Recall · January 2, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: FlexViewing PC Azurion Model Name - Model Number:Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure.
- Class II
Medical Device Recall · January 2, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura XperDual In-Line Memory Modules (DIMMs) may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
- Class II
Medical Device Recall · January 2, 2024
3:1 Dermacarrier, Model Number 00219501300, skin graft carrierDue to manufacturing issue, the product is labeled as 3:1 ratio, but the ridge pattern is a 1.5:1 ratio. The problem may lead to minor tissue damage or additional unplanned graft if deemed necessary.
- Unclassified
Vehicle Recall · January 2, 2024
2023 CHEVROLET SILVERADO 2500, 2023 CHEVROLET SILVERADO 3500, 2023 GMC SIERRA 2500, 2023 GMC SIERRA 3500, 2024 CHEVROLET SILVERADO 3500, 2024 CHEVROLET SILVERADO 2500, 2024 GMC SIERRA 3500, 2024 GMC SAn unlatched tailgate may open while driving and result in a loss of unsecured cargo, creating a road hazard and increasing the risk of a crash.
- Class II
Medical Device Recall · January 2, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion ModelDisk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
- Unclassified
Vehicle Recall · January 2, 2024
2023 GENESIS GV60, 2023 HYUNDAI IONIQ 6, 2023 HYUNDAI IONIQ 5A loss of drive power increases the risk of a crash.
- Class II
Medical Device Recall · January 2, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model NumbeFramegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure.
- Class II
Drug Recall · January 2, 2024
Dr. Reddy's Laboratories, Inc.
Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-180-15Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
- Class II
Food Recall · January 2, 2024
Vermont Village Unsweetened Apple Sauce (24oz)Product contains elevated levels of patulin.
- Class II
Medical Device Recall · January 2, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC AlluDisk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
- Class I
Food Recall · December 30, 2023
Enfamil Nutramigen Hypoallergenic Infant Formula Powder with Iron cans (12.6 OZ and 19.8 OZ). UPC Code of 300871239418 or 300871239456 and Use By Date of "1 Jan 2025".Product has the potential to be contaminated with Cronobacter sakazakii.
- Class I
Food Recall · December 29, 2023
202225 SALMON BAKKA FROST FILLET 6/7KG FR FRO F LB 202002 SALMON BAKKAFROST FAROE ISLANDS 5/6KG FR FRO F LB 202012 SALMON BAKKAFROST FAROE ISLANDS 6/7KG FR FRO F LB 202022 SALMON BAKKAFROST FAROE IPotential L. mono contamination as a result of FDA environmental sampling revealing positive findings.
- Class III
Medical Device Recall · December 29, 2023
SmartPath to dStream for 1.5T, Model No. 781260, 782112An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.
- Class III
Medical Device Recall · December 29, 2023
Achieva 1.5T, Model No. 781178, 781196, 781296An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.
- Class III
Food Recall · December 29, 2023
365 Whole Foods Vegan Ultimate Veggie, Thin Cust Pizza. Item # 999209512 Topped with Vegan Mozzarella-Style Cheese, Green and Red Bell Peppers, Mushrooms, Black Olives and Red Onions. Net Wt 13.7 oUndeclared milk
- Class I
Medical Device Recall · December 29, 2023
EVair air compressor, model numbers: M1230849 and M1230847GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstr¿m Carestation/Pro ventilators, respectively. These elevated results were observed in preliminary testing that was conducted at an elevated room temperature of 40oC (104oF), at the lowest possible flow condition of 2 L/min (worstcase, minimum bias flow with no additional ventilation), and all of the gas being supplied from the compressor (i.e., FiO2 of 21% / no supplemental oxygen). GE HealthCare is continuing to evaluate the root cause for these elevated levels of formaldehyde. While these test conditions are not representative of typical clinical use conditions,GE HealthCare is taking this action to further reduce the potential for patient exposure.
- Class II
Drug Recall · December 29, 2023
Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 678Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
- Class III
Medical Device Recall · December 29, 2023
Achieva 1.5T Conversion, Model No. 781283An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.
- Class III
Medical Device Recall · December 29, 2023
Ingenia Ambition X, Model No. 782109An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.
- Class I
Medical Device Recall · December 29, 2023
EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstr¿m Carestation/Pro ventilators, respectively. These elevated results were observed in preliminary testing that was conducted at an elevated room temperature of 40oC (104oF), at the lowest possible flow condition of 2 L/min (worstcase, minimum bias flow with no additional ventilation), and all of the gas being supplied from the compressor (i.e., FiO2 of 21% / no supplemental oxygen). GE HealthCare is continuing to evaluate the root cause for these elevated levels of formaldehyde. While these test conditions are not representative of typical clinical use conditions,GE HealthCare is taking this action to further reduce the potential for patient exposure.
- Class III
Medical Device Recall · December 29, 2023
Achieva 3.0T, Model No. 781177An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.
- Class I
Medical Device Recall · December 29, 2023
EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847; c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849; d) NIGE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstr¿m Carestation/Pro ventilators, respectively. These elevated results were observed in preliminary testing that was conducted at an elevated room temperature of 40oC (104oF), at the lowest possible flow condition of 2 L/min (worstcase, minimum bias flow with no additional ventilation), and all of the gas being supplied from the compressor (i.e., FiO2 of 21% / no supplemental oxygen). GE HealthCare is continuing to evaluate the root cause for these elevated levels of formaldehyde. While these test conditions are not representative of typical clinical use conditions,GE HealthCare is taking this action to further reduce the potential for patient exposure.
- Class II
Drug Recall · December 29, 2023
Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India. Distributed by:Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380Failed Dissolution Specifications
- Class II
Drug Recall · December 29, 2023
buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Graviti PharmaceutPresence of Foreign Tablets/Capsules
- Class I
Food Recall · December 29, 2023
Soy Bean Sprouts in a package labeled in part: Sam Sung Soy Bean Sprouts, Net Wt. 1LB have a Sell By date of December 21, 2023.Listeria monocytogenes.
- Class I
Food Recall · December 29, 2023
201000 TUNA, HAWAII #1 USA W LB 201002 TUNA HAWAII #1 USA W LB 201200 TUNA FRESH, WILD Y/F,B/E #2 GRADE 201300 TUNA BLUEFIN SPAIN SPA F LB 201301 TUNA BLUEFIN SPAIN (SE) SPAIN F LB 201304 TUNA BLPotential L. mono contamination as a result of FDA environmental sampling revealing positive findings.
- Class II
Medical Device Recall · December 29, 2023
MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in procedure.
- Class II
Medical Device Recall · December 29, 2023
MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in procedure.
- Class III
Medical Device Recall · December 29, 2023
Intera 1.5T, Model No. 781195An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.
- Class I
Medical Device Recall · December 28, 2023
Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SECardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
- Class I
Medical Device Recall · December 28, 2023
Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
- Class I
Medical Device Recall · December 28, 2023
Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 403SECardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
- Class I
Medical Device Recall · December 28, 2023
Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
- Class II
Food Recall · December 28, 2023
Wellsley Farms Assorted Mini Quiches NET WT 36 OZ (2LB 4 OZ) 1.02kb Keep Frozen UPC: 8867002630. Packaged in plastic trays in a cardboard box. 2 sealed trays in a box, 10 boxes per casePossible foreign material (aluminum)