The Recall Desk

Archive

September 2023 recalls

423 recalls were announced in September 2023.

What the numbers show

Critical
4
Severe
65
High
298
Moderate
54
Low
2

Of the 423 recalls this month scored against our rubric, 1% are Critical, 15% are Severe.

Which agencies issued them

201–300 of 423

  • HighFDA (Devices)·Z-2557-2023·2023-09-20

    Radiation Dosimeter May Provide Inaccurate Dose Measurements

    Landauer is recalling certain nanoDot D2DNS radiation dosimeters because they may measure radiation exposure outside the specified accuracy range. Approximately 5,958 units worldwide are affected.

    Product
    Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 04217-000 (EMEA number VINLNAN003); b) 04217-KIT; c) 04217-SET; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2539-2023·2023-09-20

    Landauer nanoDot D2DNS Radiation Dosimeters Recalled for Accuracy Non-Conformance

    Landauer recalled 135 nanoDot D2DNS radiation dosimeters worldwide due to potential accuracy deviations outside the specified ±5.5% range in optical stimulated luminescence material.

    Product
    nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1503-2023·2023-09-20

    Twin City Foods Frozen Corn Recalled Nationwide for Listeria Risk

    Twin City Foods recalled frozen corn products due to potential Listeria monocytogenes contamination. Products distributed nationwide and internationally.

    Product
    Individually Quick Frozen (IQF) Corn distributed in BULK TOTES (1650lbs and 1750lbs) to consignees for further processing. Bulk tote labels have cooking instructions. Individually Quick Frozen (IQF) Super Sweet Corn, foodservice item, packaged in 32oz. plastic bag, 12 bags per…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2544-2023·2023-09-20

    Landauer nanoDot Radiation Dosimeters Recalled Due to Potential Accuracy Issues

    Landauer is recalling 18,638 nanoDot radiation monitoring dosimeters worldwide. Some units may measure radiation exposure outside the specified ±5.5% accuracy range, potentially affecting occupational safety monitoring.

    Product
    nanoDot D2DNS, Model Numbers: a) 03057-1MO; b) 03057-3MO; c) 03057-OTO; d) 03057-SMO; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1506-2023·2023-09-20

    Mixed Vegetables Recalled for Potential Listeria monocytogenes Contamination

    Twin City Foods is recalling mixed vegetable products sold under TopValu, Food Lion, and Kroger brands due to potential Listeria monocytogenes contamination. Products were distributed in the US and internationally.

    Product
    Mixed Vegetables BEST PRICE TOPVALU, net per bag 500g. Label is in foreign language. 4549414484120 Food Lion Mixed Vegetables Carrots, Corn, Green Beans & Peas. Product of USA, net wt. per bag 16oz, 12 bags per case. Distributed by Food Lion, LLC Salisbury, NC. UPC 35826005090…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2554-2023·2023-09-20

    Landauer nanoDot A Dosimeters Recalled for Potential Measurement Inaccuracy

    Landauer is recalling nanoDot A radiation dosimeters (Model 03501-000) because some units may measure radiation exposure outside the acceptable accuracy range. A potential non-conformance in the optical material was identified during investigation.

    Product
    nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2551-2023·2023-09-20

    Landauer nanoDot radiation dosimeters recalled for accuracy drift

    Landauer is recalling nanoDot D2DNS radiation dosimeters worldwide because some units may read outside the specified ±5.5% accuracy range due to a potential non-conformance in the Optical Stimulated Luminescence material.

    Product
    QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2540-2023·2023-09-20

    Landauer nanoDot radiation dosimeters recalled for measurement accuracy defect

    Landauer recalled 5,760 nanoDot D2DNN radiation dosimeter units worldwide due to potential inaccuracy in radiation measurement. Some units may read outside the specified +/-5.5% accuracy range due to a defect in the optical stimulated luminescence material.

    Product
    nanoDot D2DNN, Model Numbers: a) 03051-1MO; b) 03051-3MO; c) 03051-OTO; d) 03051-SMO; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2577-2023·2023-09-20

    BeamAdjust software generates incorrect calibration files for radiation detectors

    BeamAdjust software Version 2.3.3 generates incorrect calibration files when using TIFF or DICOM image reference data, affecting radiation measurement accuracy in OCTAVIUS Detector systems.

    Product
    BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (module from BeamAdjust S080032, UDI-DI: EPTWS0800320 ): " OCTAVIUS Detector 1600 SRS (T10056) (UDI-DI: EPTWT100560) " OCTAVIUS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2542-2023·2023-09-20

    Radiation Dosimeter Accuracy Issue Recall for nanoDot D2DNS

    Landauer is recalling nanoDot D2DNS radiation dosimeters due to potential measurement inaccuracy. Some units may read outside the specified +/-5.5% accuracy range.

    Product
    nanoDot D2DNS, Model Numbers: a) 03055-1MO; b) 03055-3MO; c) 03055-OTO; d) 03055-SMO; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1504-2023·2023-09-20

    Frozen Corn Recalled Due to Listeria monocytogenes Contamination

    Twin City Foods frozen corn in bulk cases is recalled nationwide due to potential Listeria monocytogenes contamination. Products were distributed to food processors in the United States, Costa Rica, China, and Japan.

    Product
    Individually Quick Frozen (IQF) Corn, distributed in bulk cases (1kg, 10kg, 12kg, 15kg, 25kg) to consignees for further processing. Cases are read in parts: Product of U.S.A. Packed By Twin City Foods, Inc. Stanwood, Washington. Super Sweet Grade A Cut Corn Blanched…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2545-2023·2023-09-20

    Radiation Dosimeter Recall: nanoDot D2DXN Units May Have Inaccurate Readings

    Landauer is recalling nanoDot D2DXN radiation dosimeters worldwide due to potential measurement inaccuracy. Some units may read outside the specified +/-5.5% accuracy range.

    Product
    nanoDot D2DXN, Model Numbers: a) 03060-1MO; b) 03060-3MO; c) 03060-OTO; d) 03060-SMO; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-1149-2023·2023-09-20

    Prescription Drug Sucralfate Suspension Recalled for Out-of-Specification Potency

    VistaPharm LLC is recalling Sucralfate Oral Suspension 1g/10mL due to out-of-specification assay results. The active ingredient concentration does not meet FDA specifications in approximately 14,400 affected bottles distributed nationwide.

    Product
    SUCRALFATE — SUCRALFATE (SUCRALFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2569-2023·2023-09-20

    Radiation monitoring dosimeters recalled for potential measurement inaccuracy

    Landauer is recalling QC (Cs-137) nanoDot D2DNS radiation dosimeters worldwide because some units may operate outside the specified accuracy range. The recall affects 10,741 units with all batch numbers.

    Product
    QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 18135-000; b) 18135-KIT; c) 18135-SET; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2535-2023·2023-09-20

    Procedural Kits with Ultrasonic Gel Recalled for Inappropriate Use Labeling

    Advance Medical Designs is recalling 117,875 procedural kits containing ultrasonic transmission gel due to mislabeling of use instructions. The recall affects kits distributed to the United States, Canada, United Kingdom, Panama, and Netherlands.

    Product
    Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2581-2023·2023-09-20

    Welch Allyn Connex Spot Monitor Recalled for Improper Copper Tape Placement

    Baxter Healthcare is recalling the Welch Allyn Connex Spot Monitor due to improper placement of copper tape on the back of the liquid-crystal display. The device was distributed in California.

    Product
    Welch Allyn Connex Spot Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1498-2023·2023-09-20

    La Reyna Gluten Free Guacamole Recalled for Temperature Control Failure

    Twin Cities Co-Op Partners is recalling 720 containers of La Reyna Gluten Free Guacamole distributed to IA, MI, MN, and WI because the product was shipped at improper temperatures without quarantine.

    Product
    La Reyna Guacamole, Gluten Free. Product Code 1780. Net Wt 16 oz. UPC 7 52830-92610 3. Ingredients: Avocado, Tomato, Cilantro, Salt, Onions. Keep Refrigerated. La Reyna, 202 4th, Vinton IA 42349
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2579-2023·2023-09-20

    Copaliner Cavity Varnish Recalled for Solvent Mislabeling Error

    Keystone Industries recalls Copaliner Cavity Varnish after discovering bottles of Copaliner Solvent were accidentally packaged in boxes labeled as varnish. The error affected 337 units distributed worldwide.

    Product
    Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to protect against penetration of amalgam into the dentina Item No. 0921526
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2543-2023·2023-09-20

    Landauer nanoDot radiation dosimeters recalled for potential accuracy deviation

    Landauer is recalling nanoDot D2DNS radiation monitoring dosimeters due to a potential defect in the OSL material. Affected devices may provide radiation exposure readings outside the specified +/-5.5% accuracy range.

    Product
    nanoDot D2DNS, Model Numbers: a) 03056-000 (EMEA number VINLNAN002); b) 03056-1MO; c) 03056-3MO; d) 03056-KIT; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1499-2023·2023-09-20

    La Reyna Salsa Roja recalled for improper temperature storage during distribution

    Twin Cities Co-Op Partners is recalling 720 containers of La Reyna Salsa Roja due to temperature storage violations. The product was shipped to customers without proper quarantine after being stored outside required refrigeration specifications.

    Product
    La Reyna Salsa Roja, Gluten Free / Medium. Product Code 1783. Net Wt 16 oz. UPC 7 52830-92630 1. Keep Refrigerated. La Reyna, 202 4th, Vinton IA 42349
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-1497-2023·2023-09-20

    La Reyna Salsa Verde recalled due to improper temperature storage

    Twin Cities Co-Op Partners Inc. is recalling La Reyna Salsa Verde after the product was stored and shipped without maintaining proper temperature specifications.

    Product
    La Reyna Salsa Verde, Gluten Free / Medium. Product Code 1784. Net Wt 16 oz. UPC 7 52830-92640 0. Ingredients: Tomatillo, Jalapenos, Onions, Garlic, Salt. Keep Refrigerated. La Reyna, 202 4th, Vinton IA 42349
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-1500-2023·2023-09-20

    La Reyna Queso Dip recalled for temperature control violations

    Twin Cities Co-Op Partners is recalling 720 containers of La Reyna Queso Dip due to temperature control violations during shipment. The product was not quarantined after being received out of specification.

    Product
    La Reyna Queso Dip. Product Code 1781. Net Wt 16 oz. UPC 7 52830-92650 9. Keep Refrigerated. Ingredients: American White Cheese, 2% Milk, White Vinegar, Onion, Salt, Jalapeno Peppers. La Reyna, 202 4th, Vinton IA 42349
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2580-2023·2023-09-20

    Denture relining kit recalled for outer box labeling error

    Keystone Industries is recalling 240 units of Henry Schein Hard Line Chairside Reline kits because the outer box is labeled as Soft Line, though the contents and instructions are correctly labeled.

    Product
    Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2562-2023·2023-09-20

    Landauer nanoDot Radiation Dosimeter Recall for Accuracy Defect

    Landauer is recalling 211,815 nanoDot D2DNS radiation dosimeters worldwide. Some units may be outside the specified ±5.5% accuracy range due to a defect in the optical material, potentially resulting in inaccurate radiation exposure measurements.

    Product
    nanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO; d) 18100-KIT; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1496-2023·2023-09-20

    La Reyna Diablo Salsa recalled for temperature abuse during storage

    Twin Cities Co-Op Partners Inc. is recalling La Reyna Diablo Salsa because the product was received and shipped at improper temperatures. Refrigerated foods improperly stored may develop harmful bacteria.

    Product
    La Reyna Diablo Salsa. Red Diablo Salsa, Hot. Product Code 1782. Net Wt 8 oz. UPC 7 52830-92710 0. Ingredients: Dried Red Peppers, Tomatoes, Onion, Salt, Sesame Seed, Garlic, Olive Oil. Keep Refrigerated. La Reyna, 202 4th, Vinton IA 42349
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2576-2023·2023-09-20

    Microbiologics KWIK-STIK ANA quality control set missing strain

    Microbiologics Inc is recalling one lot of KWIK-STIK ANA QC sets missing one of three bacterial strains required for microbiological testing.

    Product
    KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2532-2023·2023-09-20

    ASG-001 ultrasound gel recalled for mislabeling regarding use instructions

    Advance Medical Designs is recalling ASG-001 ultrasound gel due to mislabeling of use instructions. The product was distributed in the US, Canada, UK, Panama, and Netherlands.

    Product
    ASG-001; Ultrasound gel
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2533-2023·2023-09-20

    Ultrasound gel recalled for mislabeling with inappropriate use instructions

    Advance Medical Designs is recalling 50-GEL20 ultrasound gel (13,750 units, lot 21043C2328) due to mislabeling with inappropriate use instructions. The product was distributed in the US, Canada, UK, Panama, and the Netherlands.

    Product
    50-GEL20; Ultrasound gel
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2536-2023·2023-09-20

    Ultrasound Gel Procedural Kits Recalled for Inappropriate Use Mislabeling

    Advance Medical Designs is recalling procedural kits containing ultrasonic transmission gel because the product labeling does not accurately indicate appropriate use. The recall affects 460 units distributed to the US, Canada, UK, Panama, and Netherlands.

    Product
    Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 28-EG163, g) 28-EG197
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·23E068000·2023-09-18

    Hyundam Fuel Pump Recall for Potential Loss of Drive Power

    Hyundam Industrial is recalling fuel pumps where the impeller may deform, causing pump failure and loss of drive power, which increases the risk of a crash.

    Product
    FUEL SYSTEM, GASOLINE:DELIVERY:FUEL PUMP recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V641000·2023-09-18

    Jeep Wrangler and Gladiator reverse lights and camera failure recall

    Certain 2022-2023 Jeep Wrangler and Gladiator vehicles with manual transmission have a defective gear position sensor that may prevent the rearview camera from displaying and the reverse lights from illuminating, creating a visibility and safety hazard.

    Product
    JEEP — JEEP GLADIATOR, WRANGLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23E069000·2023-09-18

    Chrysler Recalls Mopar Gear Position Sensors and Transmission Assemblies

    Chrysler is recalling specific Mopar Gear Position Sensors and Transmission Assemblies because they may cause rearview camera and reverse light failures, increasing crash risk.

    Product
    POWER TRAIN:MANUAL TRANSMISSION recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V640000·2023-09-18

    2023 Dodge Durango Shifter Interference Can Cause Sudden Power Loss

    Chrysler is recalling certain 2023 Dodge Durango Pursuit vehicles because the shifter may slip out of gear while driving, causing sudden loss of drive power and increasing crash risk.

    Product
    DODGE — DODGE DURANGO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-09162023-01·2023-09-16

    Hormel SPAM Classic Cans Subject to Public Health Alert for Under Processing

    USDA FSIS issued a public health alert for specific Hormel SPAM Classic cans due to possible under-processing. Consumers should not eat the product.

    Product
    Hormel Foods Corporation — FSIS Issues Public Health Alert for Canned Meat Product Due to Possible Under Processing
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·044-2023·2023-09-15

    American Foods Group Recalls Ground Beef Due to E. Coli O103 Contamination

    American Foods Group is recalling approximately 58,281 pounds of ground beef products that may be contaminated with E. coli O103. The products were shipped to distributors in Georgia, Michigan, and Ohio.

    Product
    Green Bay Dressed Beef, LLC — American Foods Group, LLC Recalls Ground Beef Products Due to Possible E. Coli O103 Contamination
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·23V637000·2023-09-15

    Winnebago motorhomes recalled for incorrect hitch weight labels

    Winnebago is recalling multiple 2020-2022 motorhome models due to an incorrect hitch label that can lead to vehicle overloading. Dealers will install the correct label at no cost.

    Product
    WINNEBAGO — WINNEBAGO NAVION, MINNIE WINNIE, PORTO, SPIRIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V638000·2023-09-15

    2024 Forest River Palomino Truck Camper Fire Risk Recall

    Forest River is recalling certain 2024 Palomino truck campers due to an unnecessary charge line connected to the lithium battery that may cause overcharging and fire risk. Dealers will disconnect the line and install bell caps free of charge.

    Product
    FOREST RIVER — FOREST RIVER, PALOMINO PALOMINO, REAL-LITE CAMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalCPSC·23286·2023-09-14

    Chuckle & Roar Ultimate Water Beads Activity Kits Recalled for Ingestion and Choking Hazards

    Buffalo Games and Target are recalling Chuckle & Roar Ultimate Water Beads Activity Kits because ingested water beads expand and can cause choking and intestinal obstruction in children. One infant death and one serious injury requiring surgery have been reported.

    Product
    Chuckle & Roar Ultimate Water Beads Activity Kits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V635000·2023-09-14

    Gillig Recalls 2022-2023 Low Floor Buses Due to Driveshaft Fastener Issue

    Gillig is recalling 223 Low Floor transit buses from 2022-2023 because improperly tightened driveshaft fasteners could allow the driveshaft to detach, increasing crash risk.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23288·2023-09-14

    Generac Portable Generators Recalled for Fire and Burn Hazards

    Generac is recalling about 64,000 portable generators because the fuel tank can fail to vent properly, causing excess pressure and fuel expulsion that poses fire and burn hazards. Generac has received 27 incident reports, including three with severe burn injuries.

    Product
    Generac Portable Generators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23282·2023-09-14

    STIHL MSA 300 Battery-Powered Chain Saws Recalled for Slow Braking

    STIHL Incorporated is recalling about 2,800 MSA 300 battery-powered chain saws because the braking system can take longer to brake than expected, creating a laceration hazard. Consumers should stop using the product immediately and contact an authorized dealer for a free replacement of the brake drum and brake band.

    Product
    STIHL MSA 300 chain saws
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23287·2023-09-14

    Honda Lawnmowers and Pressure Washer Engines Recall Due to Starter Rope Injury Hazard

    American Honda is recalling about 391,800 lawnmowers and pressure washer engines because improperly manufactured camshafts can cause the starter rope to suddenly retract when pulled, posing an injury hazard. The company has received 2,197 reports of incidents, including seven minor injuries.

    Product
    Honda Lawnmowers and Pressure Washer Engines
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23280·2023-09-14

    Foldable Bistro Set Chairs Recalled Due to Fall Hazard

    TJX is recalling about 11,000 foldable bistro set chairs sold at Marshalls, T.J. Maxx, HomeGoods, and Homesense stores because the wooden frame can break or collapse when someone sits in it, causing falls. The firm has received seven reports of frame failure, including four involving minor injuries.

    Product
    Foldable Bistro Set Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23792·2023-09-14

    Best Buy Insignia and Yardbird Fire Tables Recalled for Burn and Impact Injury Hazards

    Best Buy is recalling approximately 1,490 Insignia and Yardbird fire tables with lava rocks because the lava rocks can split and eject, posing burn and impact injury hazards. Consumers should immediately stop using the recalled fire tables.

    Product
    Insignia and Yardbird fire tables with lava rocks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V634000·2023-09-13

    2020 Kia Stinger: Fuel Pump Defect Causes Loss of Drive Power

    Kia is recalling 2018-2021 Stinger vehicles due to a fuel control valve defect that can cause loss of drive power and increased crash risk. Dealers will update engine software and replace the fuel pump as needed.

    Product
    KIA — KIA STINGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1169-2023·2023-09-13

    Digoxin Tablets Nationwide Recall: Bottles Mislabeled with Incorrect Dosages

    Marlex Pharmaceuticals recalls Digoxin Tablets nationwide due to a labeling error where bottles are mislabeled with incorrect dosages. Bottles labeled as 0.125mg contain 0.25mg and vice versa.

    Product
    Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC# 10135-0747-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2518-2023·2023-09-13

    Trocar with oversized shaft obscures surgical view in brain operations

    Aesculap trocars manufactured with shafts too long obstruct the visual field when used with neuroendoscopes in brain surgery. Affected units distributed in nine states should not be used.

    Product
    For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V633000·2023-09-13

    2023 Toyota Tundra Load Capacity Label Incorrectly States Weight Limit

    Toyota is recalling 2023 Tundra and Tundra Hybrid vehicles with spray-on bed liners due to an incorrect load carrying capacity label. The label overstates capacity, risking vehicle overload and crashes.

    Product
    TOYOTA — TOYOTA TUNDRA HYBRID, TUNDRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2513-2023·2023-09-13

    Cook Lead Clipper Cardiac Device Sterility Recall Due to Packaging Defect

    Cook Vandergrift is recalling approximately 15,951 Cook Lead Clipper devices due to potential sterility compromise from packaging seal breaches. The surgical tool is used for cardiac lead retrieval procedures.

    Product
    Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2519-2023·2023-09-13

    Hip Prosthesis Implants Recalled for Size Mismatch Between Label and Device

    Zimmer, Inc. is recalling M/L Taper Hip Prosthesis implants where the outer package labeling and product etch do not match the actual implant size. This mislabeling could lead to implantation of the wrong-sized prosthesis.

    Product
    M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2516-2023·2023-09-13

    Fargo Ortho-K Contact Lens Recall Due to Missing FDA Approval

    PARAGON VISION SCIENCES is recalling 18,820 Fargo Ortho-K contact lenses because they were manufactured without required FDA approval. Patients should contact their eye care provider.

    Product
    Fargo Ortho-K Lens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1147-2023·2023-09-13

    OTC Topical Cream Cartons May Contain Mislabeled Prescription Toothpaste

    Capsaicin Cream 0.025% cartons labeled as pain relief cream may contain Sodium Fluoride 1.1% prescription dental toothpaste instead. Consumers should verify product contents before use.

    Product
    CAPSAICIN — CAPSAICIN (CAPSAICIN)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-2515-2023·2023-09-13

    ISee Ortho-K Contact Lenses Recalled Due to Lack of FDA Approval

    Paragon Vision Sciences is recalling 83,542 ISee Ortho-K lenses because the manufactured product lacks FDA approval coverage. This is a Class II recall.

    Product
    ISee Ortho-K Lens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2517-2023·2023-09-13

    Philips 3D9-3v Ultrasound Transducer may separate due to bonding defect

    Philips 3D9-3v Transducer units may separate at the chassis bonding, risking electric shock and tissue damage if safety systems fail. Affected units distributed worldwide.

    Product
    3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2403-2023·2023-09-13

    Azurion imaging systems recalled for stuck foot switch causing unintended radiation

    Philips recalls Azurion imaging systems because the foot switch pedal may stick in the active position, causing unintended radiation emission. Facilities should stop using the systems and contact Philips for guidance.

    Product
    Azurion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1170-2023·2023-09-13

    Digoxin Tablets Recalled Due to Reversed Dosage Labeling

    Marlex Pharmaceuticals is recalling Digoxin Tablets because bottles labeled as 0.125mg contain 0.25mg strength, and vice versa. Approximately 94 100-count bottles distributed nationwide are affected.

    Product
    Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC 10135-0748-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-09132023-01·2023-09-13

    Kirkland Signature Chicken Tortilla Soup Recalled for Gluten Misbranding

    USDA FSIS issued a public health alert for Kirkland Signature Chicken Tortilla Soup labeled as gluten-free but containing gluten. No illnesses have been reported.

    Product
    Kettle Cuisine Midco, LLC — FSIS Issues Public Health Alert for Kirkland Signature Chicken Tortilla Soup Product Due to Misbranding
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-2402-2023·2023-09-13

    Philips Allura Xper X-ray Systems Foot Pedal May Stick, Causing Unintended Radiation

    Philips Allura Xper X-ray imaging systems are being recalled because the foot switch pedal may become stuck in the active position, potentially causing unintended radiation emission. The recall affects 5,432 systems distributed nationwide.

    Product
    Allura Xper series
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2523-2023·2023-09-13

    Reusable Endoscopy Distal Attachments Recalled for Excessive DEHP Levels

    Aomori Olympus recalls 1,252 reusable distal attachment devices with DEHP chemical levels exceeding safe exposure limits per medical device standards. Devices distributed nationwide in the United States.

    Product
    Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590, MH-591, MH-592, MH-593, MH-594, MH-595, MH-596, MH-597, MH-598, MAJ-289, MAJ-290, MAJ-291, MAJ-292, MAJ-293, MAJ-294, MAJ-295, MAJ-296, MAJ-297, MAJ-663…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1490-2023·2023-09-13

    Cooperstown Cheese Company multiple cheese products recalled for Listeria risk

    Cooperstown Cheese Company recalled 12 cheese varieties distributed in New York due to potential Listeria monocytogenes contamination. Consumers should not consume affected products.

    Product
    Cooperstown Cheese Company 1. Jersey Girl 2. Toma Celena 3. Abbie 4. SK 5. Jersey Girl with garlic/rosemary 6.Jersey Girl spring onion 7. Bobby s got the Blues 8.Toma Torino 9. Jersey Gold with garlic 10. Abbie. 11. Jersey Gold 12. Marielle
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2404-2023·2023-09-13

    Medical Imaging System Recalled for Foot Pedal Malfunction Risk

    Philips MultiDiagnost-Eleva imaging systems may emit unintended radiation if the foot pedal gets stuck in the active position. The FDA is alerting healthcare facilities to this potential equipment malfunction.

    Product
    MultiDiagnost-Eleva
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V209000·2023-09-13

    School buses recalled for automatic electrical disconnect switch failure

    Certain 2021-2023 Thomas Built school buses may lose critical driving functions due to automatic electrical switch failure. Dealers will remove the faulty switch at no cost.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2522-2023·2023-09-13

    Olympus Distal Attachment Recalled for Phthalate Exceeding Permissible Levels

    Aomori Olympus Co., Ltd. recalls 1,048 Olympus Distal Attachment units used in EMR kits due to di-2-ethylhexyl phthalate (DEHP) exceeding permissible exposure limits per ISO 10993-17: 2002. Devices were distributed nationwide.

    Product
    Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1491-2023·2023-09-13

    Nestle Toll House Cookie Dough Recalled for Potential Wood Fragments

    Nestle USA is recalling Toll House Chocolate Chip Cookie Dough due to potential wood fragments. The recall affects 147,816 packages distributed across multiple U.S. states.

    Product
    Nestle Toll House, Chocolate Chip Cookie Dough, 16.5 oz. Cookie dough in bar form packaged in paperboard tray with plastic overwrap, 12 packages per case, Keep Refrigerated
    Category
    Food
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-2521-2023·2023-09-13

    ZVU Functional GI Software Recall for Incorrect Software Revision Labeling

    ZVU Functional GI Software labeled as revision 3.3.0 is incorrectly labeled; it actually contains revision 3.2.0. The mislabeling affects 20 units distributed from May to July 2023.

    Product
    ZVU Functional GI Software, REF: ZVU-3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1145-2023·2023-09-13

    Fosfomycin Tromethamine Antibiotic Recalled for Failed Stability Specifications

    Ascend Laboratories is recalling Fosfomycin Tromethamine antibiotic granules nationwide due to organic impurities exceeding acceptable levels in stability testing. No illnesses have been reported.

    Product
    FOSFOMYCIN TROMETHAMINE — FOSFOMYCIN TROMETHAMINE (FOSFOMYCIN TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1492-2023·2023-09-13

    Ruby Mountain Spring Water Recalled for Coliform Contamination

    Ruby Mountain Spring Water 3 and 5 gallon jugs are recalled due to positive coliform findings. Consumers should not drink the water.

    Product
    Ruby Mountain Spring Water 3 and 5 gallon plastic water jugs
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1493-2023·2023-09-13

    Parent's Choice and Tippy Toes Sensitivity Infant Formula Recalled

    PBM Nutritionals recalls Parent's Choice and Tippy Toes Sensitivity Premium Infant Formula due to inadvertent market release of product that had been rejected. Affected batches were distributed across multiple states.

    Product
    Parent's Choice brand Sensitivity Premium Infant Formula, 638g, packaged in plastic tubs; and Tippy Toes brand Sensitivity Premium Infant Formula, 942g, packaged in composite cans
    Category
    Food
    Distribution
    23 states
  • ModerateFDA (Drugs)·D-1146-2023·2023-09-13

    Prescription Dental Toothpaste Recalled Due to Incorrect Carton Labeling

    AvKARE is recalling Sodium Fluoride 1.1% prescription dental toothpaste because cartons are labeled as Capsaicin Cream 0.025%, though the tubes are correctly labeled. Approximately 35,184 tubes have been distributed to 19 consignees.

    Product
    SODIUM FLOURIDE — SODIUM FLOURIDE (SODIUM FLUORIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1143-2023·2023-09-13

    Prescription Drug Recall: Nexlizet Tablets Failed Dissolution Specifications

    Esperion is recalling Nexlizet (bempedoic acid and ezetimibe) tablets nationwide due to failed dissolution specifications identified during stability testing. Approximately 45,240 bottles are affected.

    Product
    NEXLIZET — NEXLIZET (BEMPEDOIC ACID AND EZETIMIBE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·23V631000·2023-09-12

    Spartan Fire Recalls Emergency Vehicles Due to Parking Brake Defect

    Spartan Fire is recalling 660 emergency vehicles because a parking brake defect may allow the vehicle to move unintentionally.

    Product
    SPARTAN FIRE — SPARTAN FIRE, KME GLADIATOR, FC-94, METROSTAR, redundant PREDATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V632000·2023-09-12

    Kentucky Trailer XL-12 Recalled for Refrigeration Unit Fire Risk

    Kentucky Trailer is recalling 2019-2023 XL-12 trailers because a refrigeration unit clutch may overheat and break, posing a fire risk.

    Product
    KENTUCKY TRAILER — KENTUCKY TRAILER XL-12
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V630000·2023-09-11

    2021-2022 Genesis vehicles fuel pump failure increases crash risk

    Hyundai is recalling certain 2021-2022 Genesis G80, GV80, and GV70 vehicles due to potential fuel pump failures that may cause loss of drive power and increase crash risk. Dealers will replace the fuel pump free of charge.

    Product
    GENESIS — GENESIS G80, GV70, GV80
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·043-2023·2023-09-09

    Custom Made Meals Recalls Bacon-Wrapped Chicken Products Due to Undeclared Milk Allergen

    Custom Made Meals, LLC is recalling approximately 1,345 pounds of bacon-wrapped chicken products because they contain undeclared milk, a known allergen.

    Product
    Custom Made Meals, LLC — Custom Made Meals, LLC Recalls Bacon Wrapped Chicken Products Due to Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V625000·2023-09-08

    2025 Ford E-350 Recalled for Transmission Park Pawl Defect

    Ford is recalling 2025 E-350 trucks and related models due to a transmission park pawl casting defect that may not fully engage, potentially causing vehicle rollaway.

    Product
    FORD — FORD F-650 INCOMPLETE CHASSIS, E-350, F-750 SD, F-650 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V626000·2023-09-08

    Lincoln Aviator and Ford Explorer battery defect poses fire and power-loss risk

    Ford is recalling 2020-2022 Lincoln Aviators and Ford Explorers with 3.0L plug-in hybrid engines. A high-voltage battery manufacturing defect may cause battery failure, loss of drive power, and fire risk.

    Product
    LINCOLN — LINCOLN, FORD AVIATOR, EXPLORER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V628000·2023-09-08

    Nissan Altima and Sentra rearview camera harness defect increases crash risk

    Nissan is recalling certain 2019-2021 Altima and 2020-2021 Sentra vehicles because the rearview camera harness can become damaged, preventing the camera display from working. This reduces rear visibility and increases the risk of crashes when backing.

    Product
    NISSAN — NISSAN SENTRA, ALTIMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V623000·2023-09-07

    2023-2024 Alfa Romeo Tonale plug-in hybrid electric vehicles recalled for fire risk

    Chrysler is recalling 2023-2024 Alfa Romeo Tonale and Dodge Hornet plug-in hybrid electric vehicles. Improperly tightened battery and high voltage connector cables can overheat and cause fires while parked or driving.

    Product
    ALFA ROMEO — ALFA ROMEO, DODGE TONALE PHEV, HORNET, TONALE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V624000·2023-09-07

    Midwest Fire Recalls 2022-2023 All-Poly Series Tanker-Pumper Fire Trucks

    Midwest Fire is recalling 2022-2023 All-Poly Series Tanker-Pumper fire trucks due to a software error that may cause a sudden loss of drive power, increasing the risk of a crash.

    Product
    MIDWEST FIRE — MIDWEST FIRE ALL-POLY SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·042-2023·2023-09-07

    USDA Recalls Frozen Pork Products Imported Without Reinspection

    Empacadora Frape, USA LLC is recalling approximately 20,455 pounds of frozen pork chicharron and carnitas that were imported without the required reinspection.

    Product
    Empacadora Frape, USA LLC, Recalls Pork Products Imported Without Benefit of Import Reinspection
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·23790·2023-09-07

    ARGO Xplorer ATVs Recalled for Fire Hazard from Fuel Overflow

    ARGO USA Inc. is recalling about 500 ARGO Xplorer ATVs due to incorrectly installed check valves and vent hoses that can cause fuel overflow and pose a fire hazard. The firm has received two reports of fuel overflow incidents, including one fire, with no injuries reported.

    Product
    ARGO Xplorer ATVs
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23791·2023-09-07

    Whirlpool ADC Commercial Clothes Dryers Recalled for Fire Hazard

    Whirlpool has recalled about 2,500 ADC brand 30 lb. capacity stacked commercial clothes dryers because they can overheat and ignite clothes, creating a fire hazard. The company has received two reports of fuel overflow incidents, including one fire, with no injuries reported.

    Product
    ADC brand 30 lb. capacity stacked commercial clothes dryers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23276·2023-09-07

    Pirelli P ZERO Race TLR Bicycle Tires Recalled for Fall Hazard

    Pirelli is recalling about 14,500 P ZERO Race TLR bicycle tires because the tire bead can unseat from the rim, causing rapid air loss and loss of control. Consumers should stop using the tires and contact Pirelli for a free replacement or refund.

    Product
    Pirelli P ZERO Race TLR Bicycle Tires
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V622000·2023-09-07

    2023-2024 BMW Models Recall: Front Passenger Knee Air Bag Deployment Failure

    BMW is recalling certain 2023 BMW XM and 2024 BMW X5, X6, X7, and Alpina XB7 vehicles because the front passenger knee air bag may not deploy as intended, increasing injury risk in a crash.

    Product
    BMW — BMW X6, XM, X5, X7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23789·2023-09-07

    Lectric eBikes Disc Brake Calipers Recalled for Crash and Injury Hazards

    Lectric eBikes is recalling about 45,000 disc brake calipers on certain e-bicycle models because the brakes can fail, causing loss of control and crashes. The firm has received four reports of lost braking power, including two injuries.

    Product
    Disc brake calipers sold on Lectric e-bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23274·2023-09-07

    Emporia Smart Plugs Recalled Due to Electric Shock Hazard

    Emporia Energy Corp. is recalling about 80,000 smart plugs sold online from July 2022 through May 2023 because they are not adequately grounded and can pose an electric shock hazard.

    Product
    Emporia Smart Plugs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V620000·2023-09-06

    Ducati Recalls 2018-2020 XDiavel Motorcycles for Side Stand Bracket Failure

    Ducati is recalling 2018-2020 XDiavel and XDiavel S motorcycles because a side stand bracket may fail, causing the stand to open while riding and shutting down the engine.

    Product
    DUCATI — DUCATI XDIAVEL S, XDIAVEL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2435-2023·2023-09-06

    Intra-Aortic Balloon Pumps recalled for unexpected gas loss and gain alarms

    Datascope's Cardiosave Hybrid Intra-Aortic Balloon Pumps may trigger unexpected alarms indicating gas loss or gain due to undocumented causes including patient movement and blood in the circuit. The FDA Class I recall affects 9,175 units.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2432-2023·2023-09-06

    Cardiosave Rescue Intra-Aortic Balloon Pumps Fail to Charge When Improperly Inserted

    Datascope Corp. is recalling 9,175 units of Cardiosave Rescue IABP devices because batteries will not charge if the console is not fully inserted into the hospital cart. Users were often unaware of this insertion requirement.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2436-2023·2023-09-06

    Cardiosave Rescue IABP Alarms May Trigger Unexpectedly During Therapy

    Datascope Corp. is recalling approximately 9,175 Cardiosave Rescue IABPs because unexpected gas-loss and gas-gain alarms may occur during therapy due to patient movement, blood in the circuit, and hardware issues.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2467-2023·2023-09-06

    EVIS EXERA III Duodenovideoscope Recalled Due to Patient Infection Reports

    Olympus Corporation recalls 6,426 units of the EVIS EXERA III Duodenovideoscope (Model TJF-Q190V) due to recent reports of patient infections. The device was distributed nationwide in the United States.

    Product
    EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1150-2023·2023-09-06

    Vegetal Vigra Capsules Recalled for Containing Unapproved Sildenafil

    The FDA is recalling Vegetal Vigra 200mg capsules nationwide because they contain sildenafil, an active ingredient in FDA-approved medications. The product was marketed without FDA approval.

    Product
    Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int'l) Corp. USA ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA. UPC 8 931028 556885
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1476-2023·2023-09-06

    Stonewall Kitchen Peanut Butter Maltballs Recalled for Undeclared Allergens

    Stonewall Kitchen brand Peanut Butter Maltballs (6oz) may contain undeclared peanut, soy, and wheat. Consumers with allergies to these ingredients should not consume this product.

    Product
    Stonewall Kitchen brand Peanut Butter Maltballs packaged in 6oz clear plastic packaging
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-2431-2023·2023-09-06

    Cardiosave Hybrid Intra-Aortic Balloon Pump charging issue recall

    The Cardiosave Hybrid Intra-Aortic Balloon Pump console fails to charge if not fully inserted into the hospital cart. Users unaware of this requirement may attempt to use a non-charged device during critical cardiac care.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53…
    Category
    Medical Device
    Distribution
    Distributed nationwide

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