Safety Recalls
RSS ↗15,364 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 9,451–9,500 of 15,364
- Class II
Drug Recall · November 1, 2024
Glenmark Pharmaceuticals Inc., USA
Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01.cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
- Class II
Drug Recall · November 1, 2024
Glenmark Pharmaceuticals Inc., USA
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, PicGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
- Class II
Drug Recall · November 1, 2024
Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, Oakland CA 94612 UPC 8 56294 00878 5, NDC 72342-100-05cGMP Deviations
- Class II
Food Recall · November 1, 2024
Item 18968101, 100138 ITALIAN MBALL DRY MIX EX, 40.84 lb. bagpotential for pieces of metal in product
- Class II
Medical Device Recall · October 31, 2024
BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- Class II
Medical Device Recall · October 31, 2024
BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- Class II
Medical Device Recall · October 31, 2024
Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.Specific lots of product have been manufactured with nonconforming raw materials resulting in the red activation knob cracking or breaking at the activation knob internal threading while the device is activated.
- Unclassified
Consumer Product Recall · October 31, 2024
Humane Inc., of San Francisco, California
Humane Charge Case Accessory for Ai PinThe lithium battery in the recalled Charge Case Accessory can overheat, posing a fire hazard.
- Unclassified
Consumer Product Recall · October 31, 2024
HALO Branded Solutions Inc., of Sterling, Illinois
Tumblers with a Metal StrawThe metal straw inside the tumbler can cut your mouth and/or fingers, posing a laceration hazard.
- Unclassified
Consumer Product Recall · October 31, 2024
Polaris Industries Inc., of Medina, Minnesota
Model Year 2023-2024 Ranger XP Kinetic Recreational Off-Road Vehicles (ROVs)The high voltage cables on the motor controller unit can be loose, causing the cable to arc or overheat while in use, posing fire and crash hazards and risk of serious injury.
- Class II
Medical Device Recall · October 31, 2024
Olympus Corporation of the Americas
EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor ("AER") has been removed as a compatible reprocessing method from the Instructions for Use when reprocessing the GIF-1THI90 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE ( GIF-1TH190 ).
- Class II
Medical Device Recall · October 31, 2024
BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- Class II
Medical Device Recall · October 31, 2024
BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- Class II
Medical Device Recall · October 31, 2024
BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- Class II
Medical Device Recall · October 31, 2024
BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- Class II
Medical Device Recall · October 31, 2024
BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- Class II
Food Recall · October 31, 2024
LEGALLY ADDICTIVE THE O.G. COOKIES MADE FROM CRACKERS+TOFFEE+CHOCOLATE+SEA SALT NET WT. 4.7OZ (133G) UPC 8 54766 00802 8 & 1.34OZ (38G) UPC 8 54766 02800 4The firm received complaints of a "rancid taste" from consumers.
- Class II
Food Recall · October 31, 2024
Curio Spice Co. brand Grains of Paradise (Korerima) - Jar 1.25 oz net wt. UPC: 672975171032Product may be contaminated with mold.
- Unclassified
Consumer Product Recall · October 31, 2024
Sanven Technology Ltd., of Rancho Cucamonga, California
Vevor Baby GatesThe gates violate the federal safety regulations for expansion gates and expandable enclosures. A child's torso can fit through the opening between the gate slat and side wall, posing an entrapment hazard to children.
- Class II
Drug Recall · October 31, 2024
Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a foil-sealed polypropylene tray, packed in a paper carton/box, MDefective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
- Class II
Medical Device Recall · October 31, 2024
BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- Class II
Medical Device Recall · October 31, 2024
BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- Class II
Medical Device Recall · October 31, 2024
BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- Class II
Medical Device Recall · October 31, 2024
Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)Patients implanted with synthetic cartilage implant, may experience a higher-than expected occurrence rate of the following hazards: revision, removal, implant subsidence, displacement, pain, nerve damage or fragmentation.
- Class II
Medical Device Recall · October 31, 2024
BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- Class II
Medical Device Recall · October 31, 2024
BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- Class II
Medical Device Recall · October 31, 2024
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.
- Class II
Medical Device Recall · October 31, 2024
BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- Unclassified
Consumer Product Recall · October 31, 2024
Harbor Freight Tools, of Calabasas, California
Bauer 20V Battery-Powered 4-Gallon Backpack SprayersThe sprayer pump on the backpack can leak chemicals into the battery compartment and can cause the battery to overheat, posing a fire hazard.
- Unclassified
Consumer Product Recall · October 31, 2024
Manhattan Comfort Inc., of Dayton, New Jersey
Manhattan Comfort Floating Wall Theater Entertainment Centers and PanelsWhen attached to drywall without toggle bolts, the panels of the recalled floating wall theater can detach and fall, posing an injury hazard to consumers. When the bottom panel is attached to any wall surface without installing the safety screw that is included with the product, the bottom panel of the recalled floating wall theater can detach and fall, posing an injury hazard to consumers.
- Class II
Food Recall · October 30, 2024
DesBio lunaSOMM Natural Sleep Support Dietary Supplement capsules, 30 count in a Blue PET bottle with a White cap. Supplement facts declare Phosphatidylserine (from non-GMO sunflower lecithin powder)Product contains undeclared soy lecithin.
- Class II
Drug Recall · October 30, 2024
Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Solutions, LLC, Bloomington, IN 47403; Manufactured for: Baxter HeaLabeling: Missing Label
- Class II
Medical Device Recall · October 30, 2024
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
- Class II
Medical Device Recall · October 29, 2024
SEASPINE ORTHOPEDICS CORPORATION
Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: NoDue to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
- Class II
Food Recall · October 29, 2024
Traditional Country Canning Spaghetti Sauce, Net Wt. 16 oz. (453g), packaged in glass jars with metal lids, 12 jars per caseUndeclared allergen - egg
- Class II
Food Recall · October 29, 2024
La Bonne Vie Camembert 8oz UPC 820581678616; 6 retail units per casepotential to be contaminated with Listeria monocytogenes
- Class II
Medical Device Recall · October 29, 2024
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
- Class II
Food Recall · October 29, 2024
R. Walters Foods, Limited Liability Corporation
Hannaford brand seafood salad; Net Wt. 12 oz. (340g); INGREDIENTS: SEAFOOD BLEND (FISH PROTEIN [ALASKA POLLOCK AND/OR PACIFIC WHITING], WATER, WHEAT STARCH, SUGAR, SORBITOL, MODIFIED POTATO STARCH, COProduct contains undeclared hydrolyzed soy protein.
- Class II
Medical Device Recall · October 29, 2024
SEASPINE ORTHOPEDICS CORPORATION
Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001 Software Version: N/A Product Description: Locking Cap Component: NoDue to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
- Class II
Food Recall · October 29, 2024
Glenview Farms Spreadable Brie 2, 3lb tubs per casepotential to be contaminated with Listeria monocytogenes
- Class II
Drug Recall · October 29, 2024
Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.Crystallization
- Class III
Drug Recall · October 29, 2024
Dr. Reddy's Laboratories, Inc.
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05Failed Tablet/Capsule Specifications
- Class II
Drug Recall · October 29, 2024
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New JerseDefective Container: 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
Food Recall · October 29, 2024
Aldi Emporium Selection Brie 8oz UPC 4099100084016; 12 retail units per case La Bonne Vie Brie 8oz UPC 820581678531; 6 retail units per case (No Brand) Industrial Brie 8oz UPC 077901005229; 12 unitspotential to be contaminated with Listeria monocytogenes
- Class II
Medical Device Recall · October 29, 2024
EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL Knee prosthesis componentFemoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging.
- Class III
Medical Device Recall · October 28, 2024
Remote Diagnostic Technologies Ltd.
Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker modeDue to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
- Class II
Medical Device Recall · October 28, 2024
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
- Class II
Medical Device Recall · October 28, 2024
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging SystemGradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
- Class II
Medical Device Recall · October 28, 2024
AMS Artificial Urinary Sphincter Control PumpPotential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
- Class II
Medical Device Recall · October 28, 2024
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2OPotential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)