Safety Recalls
RSS ↗15,379 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 14,201–14,250 of 15,379
- Class II
Medical Device Recall · January 8, 2024
BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231250 and 231251¿There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- Class II
Food Recall · January 8, 2024
Benny Ts Vesta Inc dba Vesta Firey Gourmet Toppings
the original BENNY T'S VESTA DRY HOT SAUCE HOT NET WT. 1.5OZ INGREDIENTS: Fresh Chilies, Onions, Breadcrumbs (enriched flour, water, sugar, yeast, salt, non-hydrogenated vegetable shortening), Olive OThe firm was notified by the North Carolina Dept of Agriculture and Consumer Services that the product labeling does not include wheat and other ingredient common names in the ingredient statement.
- Class II
Medical Device Recall · January 8, 2024
BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606 and 231607¿; 5 ug, Catalog No. 291308¿There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- Class II
Medical Device Recall · January 8, 2024
BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 and 231344¿There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- Class II
Medical Device Recall · January 8, 2024
BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232231¿There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- Class II
Medical Device Recall · January 8, 2024
BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and 231645¿There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- Class II
Medical Device Recall · January 8, 2024
BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230733¿and 231274¿There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- Class II
Medical Device Recall · January 8, 2024
BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232174 and 232175¿There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- Class II
Medical Device Recall · January 8, 2024
BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657¿and 231658¿There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- Class II
Medical Device Recall · January 8, 2024
BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231705 and 231706¿There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- Class II
Medical Device Recall · January 8, 2024
BD BBL Sensi Disc Augmentin - 3¿g, Catalog Number 291270¿used for semi-quantitative in vitro susceptibility testing.There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- Class II
Medical Device Recall · January 8, 2024
BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231536 and 231539¿There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- Class II
Medical Device Recall · January 8, 2024
BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231632¿and 231633¿There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- Class II
Medical Device Recall · January 8, 2024
BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672¿There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- Class II
Medical Device Recall · January 8, 2024
Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.The negative control was contaminated with one of the positive control pathogens (Norovirus). This would result in users getting a positive call for Norovirus when running the negative control.
- Class II
Medical Device Recall · January 8, 2024
BD BBL Sensi Disc Cefixime - 5 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231664¿There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- Unclassified
- Unclassified
Vehicle Recall · January 7, 2024
2024 NISSAN SENTRAAn owner who cannot see their VIN clearly may not recognize their vehicle is involved in a safety recall, and may not have the recall remedy performed, which could increase the risk of injury, fire, or a crash.
- Class I
Food Recall · January 6, 2024
ELV ALIPOTEC brand MEXICAN TEJOCOTE ROOT SUPPLEMENT PIECES (RAIZ DE TEJOCOTE MEXICANO SUPLEMENTO EN TROZOS), NET. WT, 0.3 0Z (7g)FDA analysis found product labeled as tejocote is actually contains yellow oleander, which is toxic to humans.
- Unclassified
Vehicle Recall · January 5, 2024
2024 HYUNDAI KONA, 2024 HYUNDAI ELANTRA, 2024 HYUNDAI VENUEA loss of drive power increases the risk of a crash.
- Class II
Food Recall · January 5, 2024
DeIorio Foods, Inc. brand Cafe Pizza Dough Sheet; Keep FrozenProduct contains conveyor belt pieces.
- Class II
Medical Device Recall · January 5, 2024
Olympus Corporation of the Americas
Hemostasis Probe, Model: CD-B622LAThe BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector.
- Class II
Drug Recall · January 5, 2024
Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDSubpotent Drug and Failed Impurities/Degradation Specifications
- Class II
Drug Recall · January 5, 2024
Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDCSubpotent Drug and Failed Impurities/Degradation Specifications
- Unclassified
Vehicle Recall · January 5, 2024
2023 ENTEGRA LAUNCHA short circuit increases the risk of a fire. In addition, a loss of drive power, power steering, and brake system control increases the risk of a crash.
- Class II
Medical Device Recall · January 5, 2024
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and LiteOPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging error. This may cause patients to experience heart failure symptoms similar to before implantation of the device.
- Unclassified
Consumer Product Recall · January 4, 2024
H.H. Brown Shoe Company Inc., of Greenwich, Connecticut
Redeemer Men's Work Boot Model DH 5379The sole is not puncture-resistant, posing an injury hazard.
- Class II
Medical Device Recall · January 4, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringePackaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the sterile barrier to be breached during transportation. This only affects two lot numbers (96922110001 and 96923100001).
- Class II
Drug Recall · January 4, 2024
Glenmark Pharmaceuticals Inc., USA
Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Village: Kishanpura, Baddi Nalagarh Road, District:Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
- Unclassified
Vehicle Recall · January 4, 2024
2023 KIA FORTEFront lower control arm failure can cause a sudden loss of steering control, increasing the risk of a crash.
- Class I
Food Recall · January 4, 2024
Dragonfly Jelly Bar Handbag 11.64oz, 17.63oz UPC Code 721557357156, 721557357163 Dragonfly Jelly Bar Backpack 7.93oz, 28.22oz UPC Code 721557357170, 721557357187Potential choking hazard; product contains konjac.
- Class I
Drug Recall · January 4, 2024
Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328, NDC 24338-856-03Labeling: Label Mix-up
- Class II
Food Recall · January 4, 2024
DELI CAROLINA STYLE MUSTARD BBQ SAUCE, 2 oz (57g), plastic cup, 96 cups/case, store in ambient temperaturesUndeclared fish (anchovy) allergen
- Class II
Food Recall · January 4, 2024
Duc De Coeur Camembert Cheese Croquettes Frozen NET WT 9 OZ (256g) UPC 2023 8391 Packaged in a cardboard cartons.Possible contamination with Listeria monocytogenes
- Unclassified
Consumer Product Recall · January 4, 2024
UBBCARE Play Yard MattressesThe recalled play yard mattresses violate multiple provisions of the federal safety regulation for crib mattresses, including the thickness test, and are missing warnings and labels. The product poses a suffocation hazard to infants.
- Unclassified
Consumer Product Recall · January 4, 2024
Bell Sports Inc., Irvine, California
Bell Slope Adult HelmetsThe strap anchor can become dislodged from the helmet when sufficient force is applied, and therefore violates the CPSC federal safety regulation for bicycle helmets. The helmets can fail to protect in the event of a crash, posing a risk of head injury.
- Unclassified
Consumer Product Recall · January 4, 2024
FKA Distributing Co. LLC, d/b/a Homedics, of Commerce Township, Michigan
Therapist Select Percussion Personal MassagersThe massagers can overheat while charging, posing fire and burn hazards.
- Unclassified
Consumer Product Recall · January 4, 2024
Ride Aventon Inc., of Brea, California
Class 2 Sinch.2 Folding E-BicyclesThe recalled e-bikes can accelerate unexpectedly, resulting in loss of control, posing crash and injury hazards.
- Class II
Medical Device Recall · January 3, 2024
USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x150mm, PE25153113 - 13x125mm, PE25153111- 11x125mm, PE25153Their is a potential that the implant curved stem may be oriented incorrectly.
- Class II
Medical Device Recall · January 3, 2024
Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.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 3.0T CX. Model (REF) Numbers 781271, 782105.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. Model (REF) Numbers 781196, 781343, 781296.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
The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral vaDiscoloration 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
SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112.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
The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. ThOne lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration dates. The kits contain pouched cassettes labeled with an expiration date of May 31, 2025, however the correct expiration date for the pouches is September 12, 2024. The kits are labeled with an expiration date of April 30, 2025, however, the correct expiration date for the kits is September 12, 2024. The issue was discovered on November 28, 2023 by a supply chain employee who determined that the kits had expiration dates beyond the FDA authorized shelf life.
- Class II
Medical Device Recall · January 3, 2024
SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.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 Initial system. Model (REF) Numbers 781178.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
Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.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
USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm, PE11151213 - 13x150mm, PE11151215 - 15x150mm, PE11151217 - 17x150mm,Their is a potential that the implant curved stem may be oriented incorrectly.
- Class II
Drug Recall · January 3, 2024
Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by:Lupin Limited, Mandideep 462 046 INDIA, NDC 681Failed Impurities/Degradation Specifications