Safety Recalls
RSS ↗15,379 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 12,551–12,600 of 15,379
- Class II
Medical Device Recall · April 16, 2024
COBALT DR MRI SureScan, Model Number DDPB3D4, 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
CROME VR MRI SureScan, Model Number DVPC3D1, 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 DDME3D4, 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 VR MRI SureScan, Model Number DVPB3D4, 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 CRT-D MRI SureScan, Model Number: DTPA2D1, 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
Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTBA2QQ. b. CLARIA MRI CRT-D SureScan, Model Number DTMA2D1. c. CLARIA MRIPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 15, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (single photon emission computerized tomography system).There is a potential issue regarding the service handles for the internal lead (Pb) covers in that the handles could loosen or release which could cause a cover to drop potentially resulting in injury to service personnel due to the weight of the cover.
- Class II
Medical Device Recall · April 15, 2024
Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity
- Class II
Medical Device Recall · April 15, 2024
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
- Class II
Medical Device Recall · April 15, 2024
BD Pyxis(TM) Anesthesia Station 4000, REF: 338Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
- Class II
Medical Device Recall · April 15, 2024
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0.it.1+TKA 1.0.1.it.1+Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment
- Class II
Medical Device Recall · April 15, 2024
BD Pyxis" MedStation ES 7-Drawer Auxiliary Tower, REF: 324Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
- Class I
Food Recall · April 15, 2024
NATURAL SOURCING INTERNATIONAL,LLC
Walmart Great Value Organic Black Chia Seeds 32 oz.Salmonella contamination
- Class II
Medical Device Recall · April 15, 2024
BD Pyxis MedStation ES, REF: 323, Medication CabinetPotential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
- Class II
Medical Device Recall · April 15, 2024
Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728144Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity
- Class II
Medical Device Recall · April 15, 2024
Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGPotential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
- Class II
Medical Device Recall · April 15, 2024
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment
- Class II
Medical Device Recall · April 15, 2024
BD Pyxis" Anesthesia Station ES, REF: 327Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
- Class II
Medical Device Recall · April 15, 2024
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.de.1+TKA 1.0.1.de.1+PApplication software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment
- Class II
Medical Device Recall · April 15, 2024
BD Pyxis MedStation 4000 System, REF: 303, Medication CabinetPotential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
- Class II
Medical Device Recall · April 15, 2024
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software:TKA 2.0.fr.1+TKA 1.0.1.fr.1+PApplication software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment
- Class II
Medical Device Recall · April 15, 2024
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.es.1 + PKA 3.0.2.es.1Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment
- Class II
Medical Device Recall · April 15, 2024
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment
- Class II
Medical Device Recall · April 15, 2024
BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower, REF: 306Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
- Class II
Food Recall · April 12, 2024
DB Yummers Mildly Spicy Barbeque Sauce packaged in 19.5 glass bottles, 12 bottles per case, UPC 7487200102.No approved scheduled process
- Class II
Medical Device Recall · April 12, 2024
APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.Screw is 16mm long instead of 22mm long.
- Class II
Food Recall · April 12, 2024
DB Yummers Sweet & Smokey Barbeque Sauce packaged in 19.5 glass bottles, 12 bottles per case, UPC 74872001101.No approved scheduled process
- Class II
Drug Recall · April 12, 2024
Dercher Enterprises, Inc., DBA Gordon Laboratories
Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01cGMP Deviations
- Class III
Food Recall · April 12, 2024
Hiland Dairy Foods Company, LLC
1. Country Club, Price Chopper, Good & Gather, Hiland, Belfonte, Great Value, Hen House Vitamin D Whole Milk, 1 gallon. 2. Country Club, Price Chopper, Good & Gather, Best Choice, Good Nature Family FMay contain potable water.
- Class II
Food Recall · April 12, 2024
DB Yummers Island Marinade Barbeque Sauce packaged in 19.5 glass bottles, 12 bottles per case, UPC 7487200103.No approved scheduled process
- Class II
Medical Device Recall · April 11, 2024
FUJIFILM Healthcare Americas Corporation
Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable).
- Class I
Food Recall · April 11, 2024
Roly Poly Bakery brand MULTIGRAIN bread; INGREDIENTS: Whole Wheat Flour, High Gluten Flour, Ryechops, Sesame, Caraway, Brownflex, Soybean, Pearl Wheat, Sunflower, Salt, Water.Product contains undeclared egg.
- Unclassified
Consumer Product Recall · April 11, 2024
Innovative Bedding Solutions, of Buena Park, California
GhostBed-branded Natural MattressesThe mattresses violate the smoldering ignition requirements of the federal mattress flammability regulation, posing a fire hazard.
- Unclassified
Consumer Product Recall · April 11, 2024
Intimidator, of Batesville, Ark.
Intimidator and Mahindra branded utility vehicles (UTVs)The universal joint can fail and pierce and sever the brake line, posing a crash hazard.
- Unclassified
Consumer Product Recall · April 11, 2024
Yoto Mini speakersThe speaker's lithium-ion battery can overheat and catch fire, posing burn and fire hazards to consumers.
- Unclassified
Consumer Product Recall · April 11, 2024
Zipline KitsThe zipline's stainless-steel cable can break, posing a fall hazard.
- Unclassified
Vehicle Recall · April 11, 2024
2025 BMW X1A B-Pillar structure with reduced strength may not adequately protect passengers in a crash, increasing the risk of injury.
- Class II
Food Recall · April 11, 2024
Marketside Cinnamon Pecan Braid, Triple-Filled Danish, Filled with Cinnamon Filling, Topped with Pecans, Sweet Icing and Streusel. Net Wt. 18 oz (1 lb 2 oz) 510g. UPC 7874202922. 6 units per case.Product has incorrect back label that does not declare pecans are present in the product.
- Class II
Medical Device Recall · April 11, 2024
FUJIFILM Healthcare Americas Corporation
FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routinBolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
- Class II
Medical Device Recall · April 11, 2024
Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 and Apple iOS 17.5, a component of the Arial Emergency and Nurse Call System.The Arial Mobile Application utilizing Apple iOS 17.4 and iOS 17.5 is frequently restarting causing the app to receive alerts for all pending alarm notifications and other events when the app restarts, experience difficulty in placing and maintaining staff-to-staff phone calls, and frequently appears offline while the app restarts.
- Unclassified
Consumer Product Recall · April 11, 2024
Delta Cycle, of Foxborough, Massachusetts
Delta Cycle and Dimension Stem RaisersThe Stem Raiser can shift during use, causing the bicycle's handlebar to shift unexpectantly, posing a fall hazard.
- Unclassified
Consumer Product Recall · April 11, 2024
BRS Liquid Fuel BottlesThe portable fuel bottles do not meet the child-resistant requirements for closures under the Children's Gasoline Burn Prevention Act (CGBPA). The closure for the products is not child-resistant, posing a risk of burn and poisoning to children.
- Unclassified
Consumer Product Recall · April 11, 2024
Fischer Sports US, of Auburn, New Hampshire
Fischer RC4 Junior Ski BootsThe ski boot cuff can rotate, causing the lock mechanism to malfunction, posing a fall hazard and risk of injury to the consumer.
- Unclassified
Consumer Product Recall · April 11, 2024
Red Land Cotton, Moulton, Alabama
Red Land Cotton "Quilts" and "Quilted Shams"Pieces of broken needles were found inside some quilts and quilted shams, posing a laceration hazard.
- Unclassified
Consumer Product Recall · April 11, 2024
Johnson Health Tech North America Inc., of Cottage Grove, Wis.
Matrix T1 and T3 Series Commercial TreadmillsThe power cord can become loose from the treadmill's power socket, posing a fire hazard.
- Unclassified
Consumer Product Recall · April 11, 2024
Jian De Shi Jia Jin Chu Kou You Xian Gong Si DBA Touchat, of China
Touchat Large Fuzzy Area RugsThe recalled area rugs violate the mandatory federal flammability regulations for carpets and rugs, posing a fire hazard.
- Class II
Medical Device Recall · April 10, 2024
9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.Due to incorrect milled titanium abutment being packaged and labeled.
- Class II
- Class III
Drug Recall · April 10, 2024
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01Out of specification for assay