The Recall Desk

Archive

August 2023 recalls

693 recalls were announced in August 2023.

What the numbers show

Critical
15
Severe
87
High
526
Moderate
65

Of the 693 recalls this month scored against our rubric, 2% are Critical, 13% are Severe.

1–100 of 693

  • SevereNHTSA·23V608000·2023-08-31

    Triple E Recalls 2021-2023 Unity Motorhomes Due to Fire Risk

    Triple E is recalling 2021-2023 Unity motorhomes because a battery disconnect switch may short circuit, increasing the risk of a fire.

    Product
    TRIPLE E — TRIPLE E UNITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23788·2023-08-31

    Polaris MATRYX PRO RMK and MATRYX RMK KHAOS Snowmobiles Recalled for Puncture Hazard

    Polaris is recalling about 15,900 Model Year 2022–2023 MATRYX PRO RMK and MATRYX RMK KHAOS snowmobiles because handlebar hooks pose a puncture hazard and risk of serious injury during crashes. The firm has received four reports of puncture wounds.

    Product
    Polaris Snowmobiles, Model Year 2022-2023 MATRYX PRO RMK and MATRYX RMK KHAOS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23269·2023-08-31

    Frigidaire Gas Cooktops Recalled for Gas Leak and Fire Hazard

    Electrolux Group is recalling about 215 Frigidaire gas cooktops because plastic control knobs with black shafts can crack or break during use, creating a risk of gas leak and fire. Electrolux has received 63 reports of cracking or breaking, including one minor injury from a gas leak and one report of fire.

    Product
    Frigidaire Stainless-Steel 30-inch 4 Burner and 36-inch 5 Burner Gas Cooktops
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23E065000·2023-08-31

    GM Recalls Webasto Portable Charging Cords Due to Grounding Defect

    General Motors is recalling specific Webasto portable charging cords that may fail to stop charging if the ground connection is lost, posing an electric shock risk.

    Product
    EQUIPMENT:ELECTRICAL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V610000·2023-08-31

    Kia 2022–2023 Sorento Hybrid rearview camera mounting clips may break

    Kia is recalling certain 2022–2023 Sorento, Sorento Hybrid, and Sorento PHEV vehicles because the rearview camera mounting clips may break, preventing the camera image from displaying properly and reducing rear visibility.

    Product
    KIA — KIA SORENTO HYBRID, SORENTO, SORENTO PHEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23270·2023-08-31

    Apollo Phantom Electric Scooters Recalled for Fall and Injury Hazards

    Apollo Imports Inc. is recalling approximately 3,900 Apollo Phantom Electric Scooters because a stem bolt can come loose, causing the suspension and wheel assembly to separate and posing a fall and injury hazard. The company has received seven reports of bolt breaking, including three injuries.

    Product
    Apollo Phantom Electric Scooters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23787·2023-08-31

    Chemboys DIYChemicals Potassium and Sodium Hydroxide Lacks Child-Resistant Packaging

    Chemboys is recalling DIYChemicals potassium hydroxide and sodium hydroxide products because the packaging is not child-resistant and labels lack mandatory hazard information. The products pose a risk of chemical burns and eye irritation to children.

    Product
    DIYChemicals: Potassium Hydroxide/KOH Flakes and Sodium Hydroxide
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23786·2023-08-31

    Ski-Doo and Lynx Snowmobiles Recalled for Fire Hazard

    Bombardier Recreational Products is recalling about 4,070 model year 2023 Ski-Doo and Lynx snowmobiles equipped with 850 E-TEC Turbo R engines because the main injector fuel return hose can leak, posing a fire hazard.

    Product
    Ski-Doo and Lynx Snowmobiles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23272·2023-08-31

    Boon Flair and Flair Elite Highchairs Recalled for Fall Hazard

    TOMY International is recalling about 83,000 Boon Flair and Flair Elite highchairs because loose bolts can allow the seat to detach from the base, creating a fall hazard. The company has received 34 reports of separation, including 24 falls with 11 injuries.

    Product
    Boon Flair & Flair Elite highchairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V609000·2023-08-31

    2022 Subaru BRZ vehicles recalled for inoperative rear turn signals

    Subaru is recalling certain 2022 BRZ and Toyota GR86 vehicles because the rear turn signals may intermittently stop working. Inoperative signals increase the risk of a crash by failing to notify other drivers of a turning vehicle.

    Product
    SUBARU — SUBARU, TOYOTA BRZ, GR86
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V607000·2023-08-31

    Nova Bus LFS Transit Buses Electrical Short Circuit Fire Risk

    Nova Bus is recalling 2017–2023 LFS and LFS Artic transit buses due to a potential electrical short circuit in the 24-volt power cable and fuse holder assembly that may cause overheating and fire risk while driving or parked.

    Product
    NOVA BUS — NOVA BUS LFS, LFS ARTIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23271·2023-08-31

    Prime-Line Recalls Glass Doorknobs Due to Laceration Hazard

    Prime-Line glass doorknobs can crack and separate, creating a laceration hazard. The firm has received five reports of injuries requiring stitches.

    Product
    Glass Doorknobs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1479-2023·2023-08-30

    Soft Serve on the Go Ice Cream Recalled Due to Listeria Contamination

    Real Kosher Ice Cream's Soft Serve on the Go Caramel Vanilla ice cream (8 fl oz) may be contaminated with Listeria monocytogenes. The product was distributed across multiple US states and internationally.

    Product
    Soft Serve on the Go brand Caramel Vanilla flavor; 8 fl oz; UPC 0-91404-15131-3
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-1481-2023·2023-08-30

    Soft Zero on the Go Lite Peanut Butter Ice Cream Recalled for Listeria

    Soft Zero on the Go brand Lite Peanut Butter ice cream is being recalled due to potential Listeria monocytogenes contamination. The affected product was distributed across multiple U.S. states and internationally.

    Product
    Soft Zero on the Go brand Lite Peanut Butter flavor; 8 fl oz; UPC 0-91404-15285-3
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-1451-2023·2023-08-30

    Team Fresh & Go Mixed Fruit Cup Recalled Due to Potential Listeria Contamination

    Freshy Foods, LLC is recalling Team Fresh & Go Mixed Fruit Cup due to potential Listeria monocytogenes contamination in 249 units distributed to facilities in Florida, Louisiana, and Mississippi.

    Product
    Team Fresh & Go: Mixed Fruit Cup, packaged in 16oz plastic cup with lid. Packaged and sold as single unit.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1452-2023·2023-08-30

    Pineapple Cup Recall Due to Listeria Contamination Risk

    Freshy Foods, LLC is recalling Team Fresh & Go Pineapple Cups due to potential Listeria monocytogenes contamination. The recall affects 214 units distributed in Florida, Louisiana, and Mississippi.

    Product
    Team Fresh & Go: Pineapple Cup, packaged in 12oz plastic cup with lid. Packaged and sold as single unit.
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·23V606000·2023-08-30

    Micro Bird Recalls G5 Transit Buses Due to Seat Detachment Risk

    Micro Bird is recalling 2018-2019 and 2021 G5 transit buses because seats over the fuel filler may detach, increasing injury risk in a crash.

    Product
    MICRO BIRD — MICRO BIRD G5 TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1477-2023·2023-08-30

    Soft Serve on the Go Vanilla Chocolate Ice Cream Recalled for Listeria

    Real Kosher Ice Cream, Inc. is recalling Soft Serve on the Go brand Vanilla Chocolate ice cream due to potential Listeria monocytogenes contamination. The product was distributed across multiple U.S. states and several countries.

    Product
    Soft Serve on the Go brand Vanilla Chocolate flavor; 8 fl oz; UPC 0-91404-15129-0 Soft Serve on the Go brand Parve Vanilla Chocolate flavor; 8 fl oz; UPC 0-91404-15113-9
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-1478-2023·2023-08-30

    Soft Serve on the Go Peanut Butter ice cream recalled for Listeria contamination

    Real Kosher Ice Cream recalls Soft Serve on the Go Peanut Butter ice cream due to potential Listeria contamination. Consumers should discard the product or return it.

    Product
    Soft Serve on the Go brand Razzle n' Dazzle Peanut Butter flavor; 8 fl oz; UPC 0-91404-15133-7
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-1480-2023·2023-08-30

    Soft Serve on the Go Strawberry Mango Sorbet Recalled for Listeria Contamination Risk

    Real Kosher Ice Cream, Inc. is recalling Soft Serve on the Go brand Strawberry Mango Sorbet due to potential Listeria monocytogenes contamination. The product was distributed across multiple U.S. states and international locations.

    Product
    Soft Serve on the Go brand Sorbet Strawberry Mango Sorbet flavor; 8 fl oz; UPC 0-91404-15128-3
    Category
    Food
    Distribution
    20 states
  • SevereNHTSA·23V604000·2023-08-30

    Volkswagen Recalls 2019-2020 Models for Ignition Switch Failure Risk

    Volkswagen is recalling specific 2019-2020 models because the ignition switch may fail, causing the engine to stall while driving and increasing crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN GOLF SPORTWAGEN, GTI, JETTA, GOLF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1450-2023·2023-08-30

    Freshy Foods Recalls Team Fresh & Go Cantaloupe Cups for Listeria Risk

    Freshy Foods is recalling Team Fresh & Go Cantaloupe Cups due to potential Listeria monocytogenes contamination. The affected product was distributed in Florida, Louisiana, and Mississippi.

    Product
    Team Fresh & Go: Cantaloupe Cup, packaged in 12oz plastic cup with lid. Packaged and sold as single unit.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2248-2023·2023-08-30

    Carina Sub-Acute Care Ventilator Recalled for Toxic Chemical Emission

    Draeger Medical is recalling 11,621 Carina Sub-Acute Care Ventilators because polyurethane components emit 1,3-Dichloropropan-2-ol at levels exceeding safe limits during extended use in pediatric patients.

    Product
    Carina Sub-Acute Care Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1097-2023·2023-08-30

    Yager's Liniment Recalled for Manufacturing Practice Violations

    Ecometics recalls Yager's Liniment due to manufacturing practice violations affecting products nationwide.

    Product
    YAGER'S LINIMENT (Camphor and Turpentine Oil) 3.1% and 8.12% respectively, packaged in a) 4 FL OZ (118 mL) bottles, UPC 0 11169 00004 6, and 8 FL OZ (236 mL) bottles, UPC 0 11169 00008 4, The Oakhurst Co., Dist., Levittown, NY 11756.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1106-2023·2023-08-30

    NAD+ Injectable Vials Recalled for Sterility Assurance Deficiency

    NAD+ 200mg/ml vials from Tailor Made Compounding are recalled nationwide due to lack of assurance of sterility (Lot#07192307A2, BUD 11/18/2023). Consumers should discontinue use and consult their healthcare provider.

    Product
    NAD+ 200mg/ml, 10ml vials, Tailor Made Compounding.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1087-2023·2023-08-30

    Rufinamide 200 mg Tablets Recalled for Manufacturing Process Deviation

    Aurobindo Pharma USA Inc. is recalling Rufinamide 200 mg tablets (Lot RB2023001A) because a batch was released prior to manufacturing approval. The FDA classified this as a Class II recall.

    Product
    RUFINAMIDE — RUFINAMIDE (RUFINAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2447-2023·2023-08-30

    Air/Water Valve Used with Olympus Endoscopes May Malfunction

    Olympus air/water valves used with ultrasonic endoscopes may fail during automated reprocessing, potentially allowing body fluids to backflow into the air channel. Approximately 29,590 units nationwide are affected.

    Product
    The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE: GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5, GF-UCT180, GF-UM20, GF-UM130, GF-UMQ130, GF-UM160, GF-UC160P-OL5, GF-UCT160-OL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2439-2023·2023-08-30

    BioFire Respiratory Panel 2.1 may produce false negative results

    BioFire Respiratory Panel 2.1 kits for FILMARRAY systems may return false negative results due to a manufacturing defect. The recall affects 705 kits distributed to healthcare facilities in the U.S. and select international locations.

    Product
    BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Drugs)·D-1100-2023·2023-08-30

    Sodium Fluoride Activator Concentrate Recalled for Manufacturing Practice Violations

    Ecometics, Inc. is recalling 32,583 bottles of Sodium Fluoride 0.96% Activator Concentrate nationwide due to manufacturing practice deviations. The product was not manufactured under current good manufacturing practices (CGMP).

    Product
    activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% in diluted Activator Solution, Net 1 FL. OZ., Manufactured for: All USA Direct, LLC, Broadview, IL 60155.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1457-2023·2023-08-30

    Butter Flavored Popcorn recalled for undeclared milk

    Bickel's Snack Foods Inc is recalling Butter Flavored Popcorn because the product contains undeclared milk. The recall affects approximately 6,048 bags distributed in Georgia and nationwide retail stores.

    Product
    Butter Flavored Popcorn Naturally & Artificially Flavored, 8oz. UPC: 70175 06021 Packaged in clear plastic bags, 9 bags per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1455-2023·2023-08-30

    Lidl Blueberry Bagels Recalled for Undeclared Sesame Allergen

    Crispy Bagel Co. is recalling Blueberry Artificially Flavored Bagels sold at Lidl for containing undeclared sesame. Approximately 3,020 units were distributed to stores in Virginia, North Carolina, and Maryland.

    Product
    Blueberry Artificially Flavored Bagels By Lidl NET WT 20 OZ (1 LB 4 OZ) 567 g UPC: 2099 0305 Packaged in a plastic bag
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2459-2023·2023-08-30

    Medicrea GRANVIA-C Cervical Fusion Device Recalled for Packaging Defects

    Medicrea International is recalling GRANVIA-C cervical intervertebral fusion devices due to a packaging non-conformity issue presenting as pinholes in inner or outer pouches, which could compromise sterility.

    Product
    GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A13131789, f)¿¿¿¿¿¿ A13132012, g)¿¿¿¿¿ B13111014, h)¿¿¿¿ B13111015, i)¿¿¿¿¿¿ B13111016, j)¿¿¿¿¿¿ B13111017, k)¿¿¿¿¿ B13111025, l)¿¿¿¿¿¿ B13111026, m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1458-2023·2023-08-30

    Doritos Nacho Cheese Tortilla Chips recalled due to undeclared soy and wheat

    Frito-Lay is recalling specific batches of Doritos Nacho Cheese Flavored Tortilla Chips because they may contain undeclared soy and wheat, which are major allergens.

    Product
    Doritos Nacho Cheese Flavored Tortilla Chips Party Size-14 1/2 oz. (411 g) Doritos Nacho Cheese Flavored Tortilla Chips, 1 oz.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2458-2023·2023-08-30

    Medicrea Cervical Fusion Implants Recalled for Packaging Defect

    Medicrea International is recalling 963 PASS LP cervical fusion implants due to potential pinholes in the device packaging. The recall affects units distributed nationwide.

    Product
    PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B02316540Z, g) B02316545Z, h) B02316550Z, i) B02317540Z, j) B02317545Z, k) B02317550Z; intervertebral fusion device - cervical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2448-2023·2023-08-30

    FDA Recalls Randox Liquid Protein Calibrators for Measurement Accuracy Error

    Randox Laboratories recalled 166 units of Liquid Protein Calibrators (IT2691) after restandardization caused Ferritin results to read approximately 10% higher than targeted calibrator values.

    Product
    Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferrin assays Catalogue Number: IT2691
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2449-2023·2023-08-30

    O-arm O2 Imaging System Ground Cable Installation Defect Recall

    Medtronic is recalling O-arm O2 imaging systems due to an incorrectly installed ground cable. The defect affects 28 units distributed across the US and internationally.

    Product
    The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm and is intended to be used where a physician benefits from 2D and 3D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1453-2023·2023-08-30

    Romaine Lettuce Recall for Potential Deer Feces Contamination

    Pearson Foods Corporation is recalling romaine lettuce due to potential contamination with deer feces. The affected product was distributed in Illinois, and consumers should not consume it.

    Product
    Pearson Foods Lettuce Romaine. 1, 2.5lb bag per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1105-2023·2023-08-30

    Compounded Semaglutide/Cyanocobalamin Vials Recalled for Sterility Concerns

    Tailor Made Compounding is recalling 9 vials of Semaglutide/Cyanocobalamin 2mg/0.4mg/mL due to inability to assure sterility. The product was distributed nationwide.

    Product
    Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2443-2023·2023-08-30

    Femur nail surgical implant mislabeled with incorrect product length

    Smith & Nephew recalled a femur nail surgical implant because some packages contained a 40cm product instead of the labeled 36cm version. No injuries have been reported.

    Product
    TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2456-2023·2023-08-30

    Intervertebral fusion device recalled for packaging non-conformity issue

    Medicrea International is recalling 4,489 IMPIX MANTA intervertebral fusion devices due to potential pinholes in product packaging that could compromise device sterility.

    Product
    IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, g) B20181773, h) B20181943, i) B20181953, j) B20181963, k) B20181973, l) B20182253, m) B20182263; intervertebral fusion device - lumbar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2430-2023·2023-08-30

    Infusion pump alarm may fail to sound due to manufacturing defect

    ICU Medical recalls approximately 93,135 Plum 360 infusion pumps due to a manufacturing defect that could prevent alarm signals from sounding. The devices were manufactured between July 2020 and December 2021.

    Product
    Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453, 300100481, 300100483, 300100613, 300101013, 300101113, 300101114, 300101313, 300101379, 300102213, 300102713, 300102913, 300103413, 30010341
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2442-2023·2023-08-30

    EMBLEM MRI S-ICD Pulse Generator Recall for Rare Sensing Disablement

    Boston Scientific recalls the EMBLEM MRI S-ICD Pulse Generator due to a rare interaction with the LATITUDE communicator that may disable the device's sensing capability for up to 24 hours.

    Product
    EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1460-2023·2023-08-30

    Green Curry Paste in Every Plate Meals Recalled for Spoilage Due to Temperature Abuse

    Every Plate is recalling Green Curry Paste (1 oz, 28g) in meal codes 87 and 116 due to spoilage from temperature abuse. The affected product was distributed to customers in eight states.

    Product
    Green Curry Paste (one ounce) 28g contained in Every Plate meal code 87, 116.
    Category
    Food
    Distribution
    8 states
  • HighNHTSA·23V603000·2023-08-30

    Interstate Recalls 2023 ITLT716A2 Trailers Due to Pinch Hazard

    Interstate is recalling 2023 ITLT716A2 trailers because steel tie-down straps may interfere with the deck tilt latch, creating a pinch point that increases the risk of injury.

    Product
    INTERSTATE — INTERSTATE ITLT716A2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2452-2023·2023-08-30

    IMPIX 3D spinal implant recalled for packaging pinhole defect

    Medicrea International is recalling 248 units of IMPIX 3D intervertebral fusion devices due to pinholes in the product packaging. The recall covers devices distributed nationwide.

    Product
    IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B242C12062810, g) B242C12122810, h) B242C12123310, i) B242C13062810, j) B242C13122810, k) B242C14122810, l) B242C15122810, m) B247C07062
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2446-2023·2023-08-30

    Randox Liquid Urine Control Level 2 Recalled for Analytical Accuracy Issues

    Randox Liquid Urine Control Level 2 (Lot 1209UC) is recalled for incorrect hCG and cortisol values and a transcription error in instructions. The defects may delay patient test reporting.

    Product
    Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Osmolality, pH, Phosphate Inorganic, Potassium, Protein Total, Sodium, Specific
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2455-2023·2023-08-30

    IMPIX DLIF Intervertebral Fusion Device Recalled for Packaging Defect

    Medicrea International is recalling IMPIX DLIF intervertebral fusion devices due to potential pinholes in product packaging that could compromise sterility.

    Product
    IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, g) B16124513, h) B16164009, i) B16164013, j) B16165009, k) B16165013; intervertebral fusion device - lumbar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2445-2023·2023-08-30

    Dolomite Gloss Rollator Structural Failure Recall: Seat Collapse Risk

    Dolomite Gloss Rollator models may experience seat failure and structural collapse due to broken eyelets and crossbar, potentially causing user injury. About 586 units nationwide are affected.

    Product
    DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654807 - DOLOMITE GLOSS 680 ROLLATOR 1655081 - DOLOMITE GLOSS 600 ROLLATOR 1655082 - DOLOMITE GLOSS 520 ROLLATOR 1655083 - DOLOMITE GLOSS 450 ROLLATOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2440-2023·2023-08-30

    FilmArray Pneumonia Panel Recalled Due to Manufacturing Defect Causing False Negatives

    BioFire Diagnostics recalled FilmArray Pneumonia Panel diagnostic kits due to a manufacturing defect that may produce false negative results, potentially causing missed pneumonia diagnoses.

    Product
    FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Drugs)·D-1101-2023·2023-08-30

    FDA Recalls AstrinGyn Surgical Hemostatic Due to Manufacturing Practice Deviations

    Ecometics is recalling 92,967 vials of AstrinGyn (Ferric Subsulfate) Aqueous due to manufacturing practice violations. The product was not manufactured under current good manufacturing practices (CGMP).

    Product
    AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1102-2023·2023-08-30

    Lugol's Strong Iodine Solution Recalled Due to Manufacturing Quality Deviations

    Ecometics, Inc. is recalling Lugol's Strong Iodine Solution nationwide due to manufacturing quality deviations. Consumers with affected prescription vials should consult their healthcare provider.

    Product
    Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use Vials, Rx Only, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6064-0, Ref 6064.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1104-2023·2023-08-30

    OTC Drug Products Recalled for Rodent Contamination and Storage Violations

    Inmar Supply Chain Solutions is recalling all OTC drug products due to potential rodent exposure in its distribution center and temperature excursions during storage that may have compromised product integrity.

    Product
    All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by Inmar.
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-2460-2023·2023-08-30

    Medicrea IMPIX C+ Cervical Fusion Device Recalled for Packaging Defect

    Medicrea is recalling IMPIX C+ cervical intervertebral fusion devices due to a potential packaging non-conformity that presents as a pinhole in the product pouch. The defect could affect product integrity for this implantable device.

    Product
    IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2441-2023·2023-08-30

    EMBLEM S-ICD Pulse Generator May Lose Heart Sensing for 24 Hours

    Boston Scientific is recalling 3,856 EMBLEM S-ICD heart devices due to a rare interaction with the LATITUDE communicator that may disable sensing of dangerous heart rhythms for up to 24 hours.

    Product
    EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2451-2023·2023-08-30

    ADVIA Chemistry Urinary Protein Reagent Carryover Causing Incorrect Creatinine Results

    A reagent carryover issue in Siemens ADVIA Chemistry urinary protein test kits can cause falsely low creatinine test results. The problem occurs when the creatinine test is run after the protein test on the same system.

    Product
    ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determination of total protein in human urine and cerebrospinal fluid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2454-2023·2023-08-30

    Intervertebral Fusion Device Recalled for Potential Packaging Defect

    Medicrea International is recalling 5 units of IMPIX ALIF intervertebral fusion devices due to a potential packaging defect—a pinhole in the inner or outer pouch.

    Product
    IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2462-2023·2023-08-30

    Medicrea IMPIX MANTA+ Cervical Fusion Devices Recalled for Packaging Defect

    Medicrea International is recalling IMPIX MANTA+ cervical intervertebral fusion devices due to potential packaging non-conformity with pinholes in inner or outer pouches. No illnesses or injuries reported.

    Product
    IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B20171953, g) B20171963, h) B20171973, i) B20172253, j) B20172263, k) B20172273; intervertebral fusion device - cervical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2444-2023·2023-08-30

    Femoral nail implant recalled for product labeling and packaging mismatch

    Smith & Nephew is recalling 32 units of a femoral nail implant due to labeling mismatch. The package contained 40cm implants but was labeled as 36cm, which could result in incorrect surgical implantation.

    Product
    TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1094-2023·2023-08-30

    Moxifloxacin-Bromfenac Eye Drops Recalled for Subpotent Bromfenac Levels

    Imprimis NJOF, LLC is recalling 2,683 bottles of Moxifloxacin-Bromfenac eye drops nationwide because Bromfenac levels fall below the 90-110% specification (affected lots: 22DEC047 exp. 9/16/23, 23FEB057 exp. 11/24/23).

    Product
    Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC: 71384-311-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2461-2023·2023-08-30

    Cervical intervertebral fusion devices recalled for packaging defect

    Medicrea International is recalling IMPIX S cervical intervertebral fusion devices due to a potential packaging defect involving pinholes in the inner or outer pouch. No injuries have been reported.

    Product
    IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1099-2023·2023-08-30

    Unguentine Ointment Recalled Due to Manufacturing Practice Deviations

    Ecometics, Inc. is recalling Unguentine Ointment because products were not manufactured under current good manufacturing practices. The recall affects 6,660 tubes distributed nationwide.

    Product
    Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide 6.6%), labeled as a) NET WT 1 OZ (28 g) tubes, Improved Formula, UPC 0 11169 10216 0, and b) NET WT 1 OZ (28.3g) tubes, Maximum Strength, UPC 0 11169 11250 3, Distributed by: Oakhurst Company, Levittown
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1095-2023·2023-08-30

    Prescription Drug Trandolapril and Verapamil Tablets Recalled for Subpotency

    Glenmark Pharmaceuticals is recalling Trandolapril and Verapamil Extended-Release Tablets because they are subpotent—they do not contain their full specified amount of active ingredient. The issue was found during three-month stability testing.

    Product
    TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE — TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE (TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1096-2023·2023-08-30

    Blis-To-Sol Tolnaftate Liquid Recalled for Manufacturing Practice Deviations

    Ecometics, Inc. is recalling Blis-To-Sol Liquid (Tolnaftate) nationwide due to manufacturing practice violations. No illnesses have been reported.

    Product
    Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottles, UPC 0 11169 20011 8 and b) 1.85 FLUID OZ. (54.5 mL) bottles, UPC 0 11169 20012 5, Distributed by Oakhurst Company, Levittown, NY 11756.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1090-2023·2023-08-30

    Helix Pain Relieving Cream recalled nationwide for manufacturing process violations

    Parker Laboratories is recalling Helix Pain Relieving Cream due to manufacturing process deviations. The voluntary recall affects multiple package sizes distributed nationwide and internationally.

    Product
    Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01), b) 3 fl. oz. roll-on (NDC 30775-051-03), c) 4 fl. oz. tubes (NDC 30775-051-04), d) 12 fl oz pump bottles (NDC 30775-051-12), e) 32 fl. oz. pump bottles (NDC 30775-051-32), f) 1 U.S. gallon wi
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1088-2023·2023-08-30

    Rufinamide Tablets Recalled Due to Manufacturing Quality Deviation

    Aurobindo Pharma USA Inc. is recalling Rufinamide 400 mg tablets due to manufacturing quality deviations. The affected batch was released prior to approval.

    Product
    RUFINAMIDE — RUFINAMIDE (RUFINAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1092-2023·2023-08-30

    Helix CBD Therapy Cream Recalled Due to Manufacturing Deviations

    Parker Laboratories voluntarily recalled Helix CBD Therapy Cream due to Current Good Manufacturing Practice deviations. The recall affects specific lot numbers distributed nationwide and internationally.

    Product
    Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-053-01), b) 2 fl. oz. tubes (NDC 30775-053-02), c) 4 fl. oz. tubes (NDC 30775-053-04), Parker Laboratories Inc., Fairfield, NJ, 07004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1098-2023·2023-08-30

    ALCOLADO RELAMPAGO topical liniment recalled for manufacturing process violations

    Ecometics, Inc. is recalling ALCOLADO RELAMPAGO (menthol and camphor) topical liniment nationwide due to manufacturing process deviations. Products were not manufactured under current good manufacturing practices.

    Product
    ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged in a 7 FLUID OZ (207 ml) bottles, UPC 7 18864 20102 9 and b) 16 FLUID OZ (472 ml) bottles, UPC 7 18864, 20110 4, Distributed by: The Larkspur Group, Inc., Norwalk, CT 06854.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1091-2023·2023-08-30

    Helix Tri-Active Therapy Cream Recalled for Manufacturing Quality Deviations

    Parker Laboratories is voluntarily recalling Helix Tri-Active Therapy Cream due to manufacturing quality control deviations. The recall affects products with lot numbers A1221010 and A1221011, expiring December 9, 2023, distributed in the United States, Singapore, Korea, and Hong Kong.

    Product
    Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%), packaged in a) 3 fl. oz. roll-on (NDC 30775-052-03) and b) 4 fl. oz. tube (NDC 30775-052-04) Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1103-2023·2023-08-30

    Prescription Injection Recalled Due to Missing or Peeled Labels

    Baxter Healthcare Corporation recalls Bendamustine Hydrochloride injection nationwide because labels are missing or partially peeled off vials, raising the risk of medication errors.

    Product
    BENDAMUSTINE HYDROCHLORIDE — BENDAMUSTINE HYDROCHLORIDE (BENDAMUSTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1456-2023·2023-08-30

    Fanta Orange Zero Sugar bottles mislabeled; contain regular sugar product

    RQA, Inc. is recalling 150 bottles of Fanta Orange Zero Sugar that were mislabeled and actually contain regular Fanta Orange with 73g of sugar instead of 0g. Affected products were distributed to retail locations in North Carolina, South Carolina, and Virginia.

    Product
    FANTA ZERO SUGAR orange 20 FL OZ (1.25 PT) 591 mL UPC 0 49000 04143 9 THE COCA-COLA COMPANY
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2453-2023·2023-08-30

    Medicrea IMPIX ALIF Lumbar Fusion Devices Recalled for Packaging Defect

    Medicrea International is recalling 11 IMPIX ALIF lumbar intervertebral fusion devices distributed nationwide due to a potential packaging defect with pinholes in the device pouch.

    Product
    IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1089-2023·2023-08-30

    Drug manufacturer recalls Protex hand sanitizer due to manufacturing quality deviations

    Parker Laboratories is recalling Protex Foaming Hand Sanitizer due to manufacturing quality control deviations. The voluntary recall affects products distributed nationwide and internationally.

    Product
    Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2 fl oz/60 mL Pump bottles (NDC 30775-040-02) and b)18 fl. oz./550 ml Pump Bottles (NDC 30775-040-18), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1093-2023·2023-08-30

    FDA Recalls Helix CBD Clinical Cream for Manufacturing Process Violations

    Parker Laboratories is recalling Helix CBD Clinical Cream due to manufacturing process deviations. The FDA Class II recall affects batches distributed nationwide and internationally; consumers should discontinue use and contact the manufacturer.

    Product
    Helix CBD Clinical Cream (Menthol 7.4%), packaged in a)3 gm pouches (NDC30775-054-01), b)2 fl. oz. tubes (NDC 30775-054-02), and c) 4 fl. oz. tubes (NDC 30775-054-04), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2457-2023·2023-08-30

    Medicrea Recalls IMPIX TLIF Fusion Devices for Packaging Defects

    Medicrea International is recalling IMPIX TLIF intervertebral fusion devices due to potential packaging defects. The devices may have pinholes in the inner or outer packaging pouches.

    Product
    IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206, k) B15901306; intervertebral fusion device - lumbar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·038-2023·2023-08-29

    Dean & Peeler Meatworks Recalls Fresh Ground Beef Due to E. Coli Risk

    Dean & Peeler Meatworks is recalling fresh ground beef products due to possible E. coli O157:H7 contamination. The products were shipped to restaurants in the San Antonio, Texas area.

    Product
    Dean & Peeler Meatworks — Dean & Peeler Meatworks, LLC, Recalls Fresh Ground Beef Products Due to Possible E. Coli O157:H7 Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·23V595000·2023-08-25

    2023 Ford F-250 and F-350 Super Duty rear axle shaft defect

    Ford is recalling certain 2023 F-250 and F-350 Super Duty vehicles with single rear wheels because the left rear axle shaft may be improperly heat-treated and could break, potentially causing loss of drive power or vehicle rollaway.

    Product
    FORD — FORD F-350 SD, F-250 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-082523-01·2023-08-25

    ShopRite Chicken Noodle Soup Recalled for Undeclared Milk Allergen

    USDA FSIS issued a public health alert for ShopRite chicken noodle soup containing undeclared milk. Consumers should not eat the product.

    Product
    Kettle Cuisine Midco, LLC — FSIS Issues Public Health Alert for Shoprite Brand Bowl & Basket Chicken Noodle Soup Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    2 states
  • HighUSDA FSIS·PHA-082523-02·2023-08-25

    Wegmans Jamaican Jerk Chicken Recalled for Undeclared Allergens

    USDA issued a public health alert for Wegmans Jamaican Jerk-style chicken products due to undeclared milk, soy, and wheat allergens.

    Product
    Wegmans Food Markets — FSIS Issues Public Health Alert for Wegmans Jamaican Jerk Style Chicken Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·23V598000·2023-08-25

    Rearview camera may fail on Lincoln Navigator and other Ford vehicles

    Ford is recalling certain 2018-2023 Lincoln Navigator and Aviator vehicles, 2022-2023 Ford Transit, and 2021 Ford Bronco vehicles. The rearview camera may fail to display when reversing, reducing visibility and increasing crash risk.

    Product
    LINCOLN — LINCOLN, FORD AVIATOR, NAVIGATOR, BRONCO, TRANSIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V601000·2023-08-25

    Audi recalls 2021 A6 and other models for incorrectly labeled brake cap

    Audi is recalling certain 2019-2021 A6 and A7 models, plus 2021 A6 Allroad and S-series models, for an incorrectly labeled brake fluid cap that could result in reduced braking ability.

    Product
    AUDI — AUDI S6, A7, S7, RS 7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V597000·2023-08-25

    2023 Ford Explorer turbocharger oil supply line may leak

    Ford is recalling certain 2023 Explorer vehicles with 2.3L GTDI engines because the turbocharger oil supply line may be damaged, causing oil leaks that increase the risk of engine fire or stall.

    Product
    FORD — FORD EXPLORER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V599000·2023-08-25

    2024 Hyundai Palisade: Occupant Detection System May Deactivate Passenger Air Bags

    The Occupant Detection System (ODS) in certain 2024 Hyundai Palisade vehicles may fail to detect occupants and deactivate the passenger-side front air bags. This increases the risk of injury during a crash in affected vehicles.

    Product
    HYUNDAI — HYUNDAI PALISADE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V596000·2023-08-25

    2023 Ford Edge Front Right Headlight May Be Too Bright or Misaimed

    Ford is recalling certain 2023 Edge vehicles. The front right headlight may be too bright or aimed incorrectly, which may cause glare and increase crash risk.

    Product
    FORD — FORD EDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V600000·2023-08-25

    2015-2023 Mack Granite trucks recalled for incorrect turn signal positioning

    Mack is recalling certain 2015-2023 GRANITE trucks because turn signals may be positioned incorrectly, reducing visibility. This could prevent other drivers from seeing when the vehicle is turning, increasing crash risk.

    Product
    MACK — MACK GRANITE (GU), GRANITE (GR)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23E064000·2023-08-24

    Streamline Recalls LA Chopper Brake Hose Kits Due to Failure Risk

    Streamline Industries is recalling LA Chopper Brake Hose Kits because the hydraulic hoses may fail, potentially causing a loss of braking ability and increasing crash risk.

    Product
    SERVICE BRAKES, HYDRAULIC:FOUNDATION COMPONENTS:HOSES, LINES/PIPING, AND FITTINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23784·2023-08-24

    Aiper Elite Pro Robotic Pool Vacuum Cleaners Recalled for Burn and Fire Hazards

    About 22,000 Aiper Elite Pro GS100 robotic pool vacuum cleaners are being recalled because the battery can overheat and catch fire when the charging cord is plugged in without the adapter. The manufacturer is replacing all recalled units with a different model.

    Product
    Aiper Elite Pro GS100 cordless robotic pool vacuum cleaners
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V594000·2023-08-24

    Kia Recalls 2016-2018 Optima and Rio Models for Trunk Latch Defect

    Kia is recalling specific 2016-2018 Optima and Rio vehicles because a cracked trunk latch base may prevent the trunk from opening from the inside, potentially trapping occupants.

    Product
    KIA — KIA OPTIMA, OPTIMA PHEV, OPTIMA HYBRID, RIO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23785·2023-08-24

    Ecnup Kids Bike Helmets Recalled Due to Head Injury Risk

    Ecnup kids bike helmets sold on Amazon do not meet federal safety standards for coverage, stability, and labeling. The helmets can fail to protect the head in a crash.

    Product
    Kids bike helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1454-2023·2023-08-23

    Black melon seeds recalled for undeclared soy and wheat allergens

    Richin Trading Inc is recalling Tim Heung Yuen Black Melon Seed due to undeclared soy and wheat allergens. The product was distributed across 12 U.S. states. Consumers with these allergies should not consume the product.

    Product
    Tim Heung Yuen Black Melon Seed 6 oz., 12 oz. Ingredients: Melon Seeds, Salt, Sugar & Anise Seed Distributed By Richin Trading Inc. TEL (626) 308-3212 Allergen Warning: This repacked product was processed on shared equipments that also processed peanuts, soybean, and nuts. UPC 7
    Category
    Food
    Distribution
    12 states
  • CriticalFDA (Devices)·Z-2383-2023·2023-08-23

    FDA Recalls Dialysis Catheters for Center Lumen Obstruction Risk

    Covidien is recalling MAHURKAR dialysis catheters because the center lumen may be blocked by excess silicone lubricant. This could delay treatment and cause blood clots, hemolysis, or embolism.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·23T005000·2023-08-23

    Yokohama Recalls 504C Tires Due to Sidewall Air Leak Risk

    Yokohama is recalling 6,992 specific 504C tires because a defective splice may allow air to leak into the sidewall, potentially causing a crash.

    Product
    TIRES:SIDEWALL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2380-2023·2023-08-23

    FDA Recalls Mahurkar Dialysis Catheter for Potential Tip Obstruction Risk

    Covidien's Mahurkar acute dialysis catheters may have excessive silicone lubricant causing tip obstruction. This could delay treatment or cause serious complications including blood clots and embolism.

    Product
    MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2384-2023·2023-08-23

    Dialysis catheters recalled for potential center lumen obstruction

    Covidien LP is recalling MAHURKAR dialysis catheters because excessive silicone lubricant coats the center lumen, potentially blocking blood flow or creating clots and other blood vessel complications.

    Product
    MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2378-2023·2023-08-23

    Dialysis catheter recall: excessive lubricant causes center lumen obstruction

    A dialysis catheter product is being recalled due to excessive lubricant coating in the center lumen, which may cause full or partial obstruction. The blockage could delay treatment and increase risk of blood clots and hemolysis.

    Product
    MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2369-2023·2023-08-23

    Dialysis Catheter Recalled Due to Silicone Lubricant Obstruction Risk

    Covidien LP is recalling 5,373 MAHURKAR dialysis catheters because excessive silicone lubricant can occlude the catheter lumen, potentially causing treatment delays or blood clotting complications.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray REF: 8888101003HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2388-2023·2023-08-23

    Dialysis Catheter Recall Due to Center Lumen Occlusion

    Covidien is recalling MAHURKAR Triple Lumen Acute Dialysis Catheters due to excessive lubricant blocking the center lumen, which may delay dialysis and cause blood clots. The recall affects 6,949 units distributed in the US and worldwide.

    Product
    MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629
    Category
    Medical Device
    Distribution
    Distributed nationwide

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