The Recall Desk

Archive

January 2024 recalls

524 recalls were announced in January 2024.

What the numbers show

Critical
12
Severe
125
High
295
Moderate
88
Low
4

Of the 524 recalls this month scored against our rubric, 2% are Critical, 24% are Severe.

Which agencies issued them

1–100 of 524

  • CriticalFDA (Food)·F-0782-2024·2024-01-31

    Publix Custom Burrito Bowls Recalled Due to Listeria Contamination Risk

    Publix Super Markets is recalling Custom Burrito Bowls due to potential Listeria monocytogenes contamination in the shredded lettuce ingredient. The bowls were distributed in Alabama, Florida, Georgia, Kentucky, North Carolina, South Carolina, Tennessee, and Virginia during December 5-14, 2023.

    Product
    Publix Custom Burrito Bowls, variable weights and sizes, packed in plastic containers, intended for immediate consumption.
    Category
    Food
    Distribution
    8 states
  • CriticalFDA (Food)·F-0781-2024·2024-01-31

    Publix Custom Made Pizzas Recalled Due to Listeria Contamination in Lettuce

    Publix Custom Made Pizzas distributed in eight states are being recalled because the shredded lettuce ingredient may contain Listeria monocytogenes.

    Product
    Publix Custom Made Pizzas, variable weights and sizes, packed in cardboard box, intended for immediate consumption.
    Category
    Food
    Distribution
    8 states
  • CriticalFDA (Food)·F-0775-2024·2024-01-31

    Tapee Tea packets recalled for undeclared pharmaceutical contamination

    Tapee Tea packaged in paper packets is being recalled because samples contain undeclared pharmaceutical substances (dexamethasone and piroxicam). The contamination poses serious health risks from unintended medication exposure.

    Product
    Tapee Tea packaged in paper packets - 5 packets per bag
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·24V058000·2024-01-31

    Heavy truck stability control software has incorrect axle spacing parameters

    Daimler Trucks is recalling certain 2024-2025 Western Star 49X and 2025 Freightliner Cascadia vehicles whose Electronic Stability Control software carries incorrect axle spacing parameters, failing FMVSS 136.

    Product
    WESTERN STAR — WESTERN STAR, FREIGHTLINER 49X, CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0316-2024·2024-01-31

    Robitussin Honey CF Max Non-Drowsy Adult recalled for microbial contamination

    GSK Consumer Healthcare recalls Robitussin Honey CF Max Non-Drowsy Adult due to microbial contamination in non-sterile products distributed nationwide. Affected lot numbers carry specific expiration dates.

    Product
    Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8 FL OZ (237 mL) bottles, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V059000·2024-01-31

    Vicinity Recalls 2017 Vi33 Buses Due to CNG Tank Clearance Issue

    Vicinity is recalling 2017 Vi33 transit buses because inadequate clearance may allow CNG tanks to contact mounting structures, potentially causing damage and gas leaks.

    Product
    VICINITY — VICINITY VI33
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0784-2024·2024-01-31

    Publix Custom Made Platters Recalled Due to Potential Listeria Contamination

    Publix is recalling custom made platters distributed across eight states due to potential Listeria monocytogenes contamination in the shredded lettuce ingredient. Consumers should not eat platters prepared between December 5-14, 2023.

    Product
    Publix Custom Made Platters, variable weights and sizes, packed in plastic containers, intended for immediate consumption (https://www.publix.com/mc/order-ahead/order-deli-platters?nav=header).
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-0788-2024·2024-01-31

    Lara's Bakery 3 LLC Recalls Pan de Racho Bread for Undeclared Allergens

    Lara's Bakery 3 LLC recalls Pan de Racho (Feria) bread distributed in Iowa and Wisconsin for undeclared allergens including sesame, with potential presence of coconut, soy, wheat, milk, and eggs.

    Product
    Pan de Racho (Feria), Net Wt. 2lbs, individually packaged in clear plastic bag.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0261-2024·2024-01-31

    Drug recall: Bleomycin injection vials recalled due to glass contamination

    Pfizer is recalling 3,546 vials of Bleomycin for Injection due to the presence of glass particulate matter. The affected lot was distributed nationwide in the USA, Netherlands, and Libya.

    Product
    BLEOMYCIN — BLEOMYCIN (BLEOMYCIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0777-2024·2024-01-31

    Outrageous Oat Cookies Recalled for Undeclared Wheat Allergen

    Wegmans Food Markets is recalling Outrageous Oat Cookies due to undeclared wheat. The product poses a serious health risk to consumers with wheat allergies or celiac disease.

    Product
    Outrageous Oat Cookies packaged in 5pk and also sold in Bulk
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0780-2024·2024-01-31

    Publix Sub Sandwiches Recalled for Potential Listeria Contamination

    Publix Custom Made Sub Sandwiches are being recalled due to potential Listeria monocytogenes contamination in the shredded lettuce ingredient supplied by Fresh Express. Products were distributed between December 5-14, 2023 in southeastern states.

    Product
    Publix Custom Made Sub Sandwiches, variable weights and sizes, individually wrapped in paper, intended for immediate consumption (https://www.publix.com/menu-subs-and-wraps?merch=hp_viz_nav_subs_wraps).
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-0789-2024·2024-01-31

    Pan Surtido Bakery Products Recalled for Undeclared Allergens

    Lara's Bakery 3 LLC is recalling Pan Surtido multi-pack bakery trays distributed in Iowa and Wisconsin through November 2023 due to undeclared allergens including sesame, coconut, soy, and milk, with potential for wheat and eggs.

    Product
    Pan Surtido with label reading: Panaderia Lara's Bakery, 701 N 3rd Ave Suite C Marshalltown IA 50158. Multi-pack tray containing Concha, Cema, Polvoron, Tostado de Guatemala, Pan de Guatemala, Canasta, Garibaldi, Marianas, Muffin, Pan Fino, Pastel Glass, Pan de Trigo, Puerco, Bol
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·24V056000·2024-01-31

    New Flyer Recalls Electric Buses Due to Battery Fire Risk

    New Flyer is recalling 337 electric buses because drain valve issues may allow liquid to accumulate in battery packs, increasing the risk of an electrical short and fire.

    Product
    NEW FLYER — NEW FLYER XE35, XE60, XHE40, XE40
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0317-2024·2024-01-31

    Robitussin Honey CF Max Nighttime Adult Recalled for Microbial Contamination

    Haleon US Holdings LLC is recalling Robitussin Honey CF Max Nighttime Adult cough medicine due to microbial contamination. The FDA Class I recall affects 21,900 bottles distributed nationwide.

    Product
    Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0783-2024·2024-01-31

    Publix Deli Chicken Street Tacos Recalled for Listeria Contamination

    Publix Deli Chicken Street Tacos for Two sold in eight southeastern states are recalled due to potential Listeria monocytogenes contamination in the shredded lettuce ingredient. Consumers should not eat this product and should discard or return it.

    Product
    Publix Deli Chicken Street Tacos for Two, variable weights and sizes, packed in plastic containers, intended for immediate consumption (https://www.publix.com/pd/publix-deli-chicken-street-tacos-for-two/RIO-PCI-238408?origin=search1).
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-0785-2024·2024-01-31

    Publix Self-Service Salad Recalled for Potential Listeria Contamination

    Publix is recalling self-service salad from its salad bar distributed December 5-14, 2023, in eight states due to potential Listeria monocytogenes contamination in shredded lettuce supplied by Fresh Express.

    Product
    Publix Self Service Salad from the Salad Bar, variable weights and sizes, packed in plastic containers, intended for immediate consumption.
    Category
    Food
    Distribution
    8 states
  • SevereNHTSA·24V057000·2024-01-31

    Kia EV drive shafts can break under load causing power loss

    Kia is recalling certain 2023-2024 Niro EV and 2023 EV6 vehicles because an improperly heat-treated drive shaft can break under load, resulting in a loss of drive power.

    Product
    KIA — KIA EV6, NIRO EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0785-2024·2024-01-31

    Beckman Coulter iQ200 Analyzers Recalled for Potential Rust and Diagnostic Errors

    Beckman Coulter is recalling 112 units of iQ200 Series Urine Microscopy Analyzers distributed globally. The cannula in the Flowcell and Rinse Waste Well Assembly may rust, potentially causing erroneous diagnostic results.

    Product
    iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3325, h) C10684
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0773-2024·2024-01-31

    Stryker Tornier Shoulder Implant Recalled for Device Packaging Mismatch

    Tornier, Inc is recalling 50 units of Stryker Tornier Perform shoulder implants because the incorrect device is contained in the labeled package. Affected batch: lot 6714AZ, serial 001–050.

    Product
    Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0784-2024·2024-01-31

    Beckman Coulter DxU Analyzers Recalled for Potential Rust-Related Diagnostic Errors

    Beckman Coulter is recalling DxU 850m/840m Microscopy Analyzers (254 units) due to potential rust in the cannula component, which may cause erroneous test results. The recall affects units distributed in the US and multiple international locations.

    Product
    Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0800-2024·2024-01-31

    Bard Nasogastric Sump Tube Recalled for Reduced Suction and Drainage

    C.R. Bard is recalling Bard Nasogastric Sump Tubes due to reports of inadequate or reduced suction, decompression, and drainage during use. The recall affects 57,159 units distributed in the United States.

    Product
    Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN0046180
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0776-2024·2024-01-31

    Frozen Vegan Pizza Recalled for Undeclared Milk Allergen

    365 Whole Foods Vegan Ultimate Veggie pizza (13.7 oz, UPC 0 99482-51870 7) is recalled for undeclared milk. Consumers with milk allergies should not consume this product. It was distributed to GA, PA, TX, and WA.

    Product
    365 Whole Foods Vegan Ultimate Veggie, Thin Cust Pizza. Item # 999209512 Topped with Vegan Mozzarella-Style Cheese, Green and Red Bell Peppers, Mushrooms, Black Olives and Red Onions. Net Wt 13.7 oz (388g) UPC 0 99482-51870 7. Keep Frozen. Distributed by Whole Foods Market,
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0815-2024·2024-01-31

    FDA Recalls DiaSorin HSV-2 Antibody Test Lots Due to False Positive Results

    DiaSorin LIAISON HSV-2 Type Specific IgG test kits are being recalled because specific lots may produce false positive or equivocal results. Affected kits were distributed in the US and Canada.

    Product
    DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0795-2024·2024-01-31

    DeIorio Foods Pizza Dough Recalled for Conveyor Belt Piece Contamination

    DeIorio Foods has recalled frozen pizza dough sheets that may contain conveyor belt pieces. The recall affects products distributed in CA, NC, and PA with best-use dates of 02/16/2024.

    Product
    DeIorio Foods, Inc. brand Cafe Pizza Dough Sheet; Keep Frozen
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0782-2024·2024-01-31

    Hologic PANTHER FUSION System Recalled for Potential False Positive Flu B Results

    Hologic is recalling PANTHER FUSION nucleic acid testing systems due to the potential for false positive influenza B test results when a sample is also positive for SARS-CoV-2.

    Product
    PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps necessary to perform Aptima assays from sample processing through amplification, detection, and data reduction. The Panther Fusion System is a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0778-2024·2024-01-31

    Accure Laser System recalled due to spot tracking misalignment risk

    Accure Acne, Inc. is recalling the Accure Laser System Model PFMS00004 because its spot tracking system may misalign, potentially delivering higher-than-expected laser energy that could cause blistering.

    Product
    Accure Laser System, Model: PFMS00004
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-0791-2024·2024-01-31

    Chocoflan Dessert Recalled for Undeclared Wheat and Other Allergens

    Lara's Bakery 3 LLC is recalling Chocoflan dessert products for undeclared wheat and potential cross-contamination with sesame, coconut, soy, milk, and eggs. Consumers with allergies should not consume this product.

    Product
    Chocoflan (Chocolate Custard Dessert), Net Wt 1/2 lb, packaged in plastic clamshell.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0793-2024·2024-01-31

    Vermont Village Apple Sauce Recalled for Elevated Patulin Contamination

    Stonewall Kitchen is recalling Vermont Village Unsweetened Apple Sauce (24oz) because the product contains elevated levels of patulin, a mycotoxin. The recall affects 9,027 units distributed across 22 U.S. states.

    Product
    Vermont Village Unsweetened Apple Sauce (24oz)
    Category
    Food
    Distribution
    22 states
  • HighFDA (Devices)·Z-0797-2024·2024-01-31

    Bard Nasogastric Sump Tubes Recalled for Reduced Suction and Drainage

    C.R. Bard is recalling 26,100 nasogastric sump tubes due to user complaints of inadequate suction and reduced drainage. The malfunction could prevent proper stomach decompression.

    Product
    Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0777-2024·2024-01-31

    Ultrasound Gel Sterility Cannot Be Guaranteed — FDA Recall

    Turkuaz Saglik Hizmetleri is recalling over 4.9 million units of sterile ultrasound gel (REF 126590) because manufacturer cannot guarantee its sterility. Affected products in Illinois and Hong Kong should not be used.

    Product
    REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0792-2024·2024-01-31

    Bard Nasogastric Sump Tubes recalled for reduced suction and drainage

    C.R. Bard is recalling 17,250 Bard Nasogastric Sump Tubes with ENFit connectors due to user complaints of inadequate or reduced suction, decompression, and drainage during use. These tubes may not function properly for their intended medical purpose.

    Product
    Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·24V055000·2024-01-31

    Motorhome retractable awnings can extend unintentionally during transit

    Jayco is recalling certain 2023 Entegra Expanse, Expanse LI, Jayco Solstice and Solstice LI motorhomes because the retractable awning may extend unintentionally while the vehicle is moving.

    Product
    JAYCO — JAYCO, ENTEGRA SOLSTICE, EXPANSE, EXPANSE LI, SOLSTICE LI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0813-2024·2024-01-31

    Ultrasound system recalled due to measurement error in Dual Live Compare feature

    B-K Medical A/S is recalling bkActiv Ultrasound System 2300 models because a measurement error could occur in the Dual Live Compare feature, potentially affecting diagnostic accuracy.

    Product
    bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0805-2024·2024-01-31

    Bard Nasogastric Sump Tube ENFit recalled for inadequate drainage

    BD (C.R. Bard) is recalling Bard Nasogastric Sump Tubes with ENFit connectors because users have reported inadequate suction, decompression, and drainage. The devices may not function properly for their intended medical purpose.

    Product
    Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 18Fr., 48in Long, REF EN0056180
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0795-2024·2024-01-31

    Bard PreVent Anti-Reflux Filter with ENFit Recall for Reduced Suction

    C.R. Bard is recalling Bard PreVent Anti-Reflux Filters with ENFit connectors due to user reports of inadequate or reduced suction, decompression, and drainage during use.

    Product
    Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0790-2024·2024-01-31

    Bard Nasogastric Sump Tube with ENFit Recalled for Reduced Suction and Drainage

    C.R. Bard is recalling 3,400 units of Bard Nasogastric Sump Tube with ENFit due to reports of inadequate suction, decompression, and drainage during use affecting patients requiring nasogastric care.

    Product
    Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0799-2024·2024-01-31

    Bard Nasogastric Sump Tube Recalled for Reduced Suction and Drainage

    C.R. Bard is recalling 51,750 Bard Nasogastric Sump Tubes with PreVent Anti-Reflux Filter due to reports of inadequate suction and drainage during use.

    Product
    Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr., 48in Long, REF EN0046160
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0779-2024·2024-01-31

    Medtronic Cobalt XT DR MRI cardioverter defibrillator battery testing defect

    Medtronic is recalling Cobalt XT DR MRI implantable cardioverter defibrillators due to a manufacturing defect in the battery testing process. Some batteries may have bypassed required validation.

    Product
    Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0781-2024·2024-01-31

    Medical X-Ray System Recall Due to Parts Falling Off

    Sedecal SA is recalling 845 Sedecal X Optima URS diagnostic x-ray systems after parts fell off the equipment, creating a safety risk to patients and users. The affected units were distributed in Alabama, Florida, and North Carolina.

    Product
    Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0802-2024·2024-01-31

    Bard Nasogastric Sump Tube Recalled for Inadequate Drainage

    C.R. Bard is recalling 3,360 units of Bard Nasogastric Sump Tubes with ENFit connectors due to reports of inadequate or reduced suction and drainage during use.

    Product
    Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 12Fr., 48in Long, REF EN0056120
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0262-2024·2024-01-31

    FDA Recalls Fosaprepitant Injection Due to Sterility Assurance Failure

    BE Pharmaceuticals recalls Fosaprepitant for Injection nationwide due to failed aseptic process validation. The 22,176 vials from lot #13D012AA may lack sterility assurance.

    Product
    FOSAPREPITANT — FOSAPREPITANT (FOSAPREPITANT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0788-2024·2024-01-31

    Power Knee Prosthetic Batteries Recalled Due to Unexpected Shutdown Risk

    Ossur Power Knee prosthetic knee batteries may fail to turn on or shut down unexpectedly, potentially causing users to lose support and fall. Affected units are distributed nationwide.

    Product
    Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0273-2024·2024-01-31

    Fexofenadine Hydrochloride Antihistamine Tablets Recalled for Microbial Contamination

    Sun Pharmaceutical is recalling Fexofenadine Hydrochloride 180mg tablets due to microbial contamination discovered in manufacturing equipment. Approximately 54,504 bottles distributed nationwide are affected by this Class II recall.

    Product
    FEXOFENADINE HYDROCHLORIDE — FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0786-2024·2024-01-31

    R&B Chocolate Chips Croissant Twist contains undeclared soy lecithin

    Lecoq Cuisine Corporation is recalling R&B Chocolate Chips Croissant Twist because the product contains undeclared soy lecithin. Consumers with soy allergies may be at risk if they consume this product.

    Product
    R&B Chocolate Chips Croissant Twist
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0772-2024·2024-01-31

    VITROS Anti-HBs Immunodiagnostic Products Recalled for Calibration Failures

    Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products used to test for Hepatitis B antibodies due to potential calibration failures and falsely elevated test results affecting specific lot numbers.

    Product
    VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0789-2024·2024-01-31

    Snapshot NIR Tissue Oxygenation System Touchscreens May Be Unresponsive

    Kent Imaging's Snapshot NIR tissue oxygenation measurement system touchscreens may become unresponsive, preventing users from viewing diagnostic oxygenation images. Fifty-seven units have been distributed across multiple US states and Malaysia.

    Product
    Snapshot NIR, REF: KD204
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0814-2024·2024-01-31

    TactiFlex Ablation Catheter Not Properly Recognized by EnSiteX EP System

    The TactiFlex Ablation Catheter is not correctly recognized by the EnSiteX EP System, which displays it as a different model, prevents certain features from appearing, and may show an inverted image.

    Product
    TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0791-2024·2024-01-31

    Bard Nasogastric Sump Tubes recalled for inadequate suction and drainage

    C.R. Bard is recalling Bard Nasogastric Sump Tubes with ENFit connectors due to reports of inadequate or reduced suction and drainage during use. The defect may prevent proper gastric decompression.

    Product
    Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0787-2024·2024-01-31

    iQ Waste Well Adapter Recalled for Rust in Cannula Component

    Beckman Coulter recalls the iQ Waste Well Adapter due to rust in the cannula that may generate erroneous test results in laboratory diagnostic equipment.

    Product
    iQ Waste Well Adapter, Part Number: 700-3393
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0806-2024·2024-01-31

    Bard Suction Connector with ENFit Recalled for Inadequate Drainage

    C.R. Bard is recalling 133,610 Bard Suction Connectors with ENFit (model EN0066000) due to user complaints of inadequate suction and drainage. No injuries have been reported.

    Product
    Bard¿ Suction Connector with ENFit, REF EN0066000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0787-2024·2024-01-31

    RTB Mixed Danish Variety Recalled for Undeclared Soy Lecithin

    Lecoq Cuisine Corporation is recalling RTB Mixed Danish Variety pastries due to undeclared soy lecithin. The recall affects 7,620 units distributed across 26 states.

    Product
    RTB MIXED DANISH Variety
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0793-2024·2024-01-31

    C.R. Bard Nasogastric Sump Tubes recalled for inadequate drainage and suction

    C.R. Bard is recalling Bard Nasogastric Sump Tubes with ENFit connectors due to user reports of inadequate suction and drainage. The recall affects 16,564 units distributed in the United States.

    Product
    Bard¿ Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0272-2024·2024-01-31

    Zolpidem Tartrate Extended-Release Tablets Recalled for Manufacturing Contamination

    SUN PHARMACEUTICAL INDUSTRIES is recalling 14,568 bottles of Zolpidem Tartrate Extended-Release 12.5mg tablets nationwide due to microbial contamination discovered in manufacturing equipment. Affected lot: DNE0893A (expires 07/31/2026).

    Product
    ZOLPIDEM TARTRATE — ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0790-2024·2024-01-31

    Pound Cake Recall for Undeclared Wheat and Multiple Common Allergens

    Lara's Bakery 3 LLC recalls Panque pound cake because the label declares gluten but omits wheat as a major allergen, with potential undeclared sesame, coconut, soy, milk, and eggs. Consumers with allergies should not consume this product.

    Product
    Panque (Pound Cake), Net Wt 2lbs, packaged in clear plastic bag.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0792-2024·2024-01-31

    Tres Leches Cake Recalled for Undeclared Wheat Allergen

    Lara's Bakery 3 LLC is recalling Tres Leches cake for undeclared wheat, a major allergen not listed despite being in the ingredient list. Consumers with wheat allergies could face allergic reactions.

    Product
    Tres Leches (Three Milk Cake), Net Wt 1/2 lb, packaged in plastic clamshell.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0794-2024·2024-01-31

    Frozen cheese croquettes recalled for possible Listeria monocytogenes contamination

    Lidl US is recalling Duc De Coeur Camembert Cheese Croquettes due to possible contamination with Listeria monocytogenes. No illnesses have been reported.

    Product
    Duc De Coeur Camembert Cheese Croquettes Frozen NET WT 9 OZ (256g) UPC 2023 8391 Packaged in a cardboard cartons.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-0796-2024·2024-01-31

    Bard Nasogastric Sump Tubes recalled for inadequate suction and drainage

    C.R. Bard is recalling Bard Nasogastric Sump Tubes due to user complaints of inadequate suction and drainage during use. Approximately 6,600 units were affected.

    Product
    Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr., 36in Long, REF EN0046100
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0783-2024·2024-01-31

    EliA GBM Diagnostic Wells Recalled for False Positive Results

    Phadia Ab recalls 124,928 EliA GBM Wells diagnostic kits distributed nationwide due to complaints of false positive results. The wells produced unexpected positive signals in samples tested without antigen.

    Product
    EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0779-2024·2024-01-31

    Odds & Ends Organic Chocolate Fruit & Nut Mix Recalled for Foreign Material

    United Natural Trading Inc. is recalling Odds & Ends Organic Chocolate Fruit & Nut Mix due to the presence of stems and vegetation. The product was distributed to Maryland, Oregon, and Massachusetts.

    Product
    Odds & Ends Organic Chocolate Fruit & Nut Mix 14oz. plastic resealable bags . 12/14oz bags per case.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0804-2024·2024-01-31

    Bard Nasogastric Sump Tube Recalled for Inadequate Suction and Drainage

    C.R. Bard Inc is recalling 8,010 units of Bard Nasogastric Sump Tubes with ENFit connectors due to reports of inadequate or reduced suction, decompression, and drainage.

    Product
    Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 16Fr., 48in Long , REF EN0056160
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0801-2024·2024-01-31

    Nasogastric Valve Recalled for Reduced Suction and Drainage

    C.R. Bard Inc. is recalling approximately 187,550 Bard Lopez Valve units due to user complaints of inadequate suction, decompression, and drainage during use. No illnesses or injuries have been reported.

    Product
    Bard¿ Lopez Valve¿ with ENFit, REF EN0056000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0258-2024·2024-01-31

    Vasopressin Syringes Recalled for Subpotency by IntegraDose Compounding Services

    IntegraDose Compounding Services recalled 281 syringes of Vasopressin 2 Unit/2 mL due to subpotency. The voluntary recall affects Lot #20230921VAS-2 distributed in Minnesota.

    Product
    Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-0190-1
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0794-2024·2024-01-31

    Bard Nasogastric Sump Tubes recalled due to inadequate suction and drainage

    C.R. Bard is recalling 37,059 units of Bard Nasogastric Sump Tubes with ENFit due to user reports of inadequate suction, decompression, and drainage during use.

    Product
    Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0798-2024·2024-01-31

    Bard Nasogastric Sump Tubes recalled for reduced suction and drainage

    C.R. Bard has recalled certain nasogastric sump tubes due to user reports of inadequate suction and drainage. The affected devices may fail to properly decompress the stomach.

    Product
    Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN0046140
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0803-2024·2024-01-31

    Bard Nasogastric Sump Tube Recalled Due to Reduced Suction and Drainage

    C.R. Bard is recalling 3,650 units of Bard Nasogastric Sump Tubes with ENFit connectors due to user complaints of inadequate suction, decompression, and drainage during use. The issue could affect proper tube function in clinical settings.

    Product
    Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 14Fr., 48in Long, REF EN0056140
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0270-2024·2024-01-31

    Prescription Niacin Tablets Recalled for Microbial Contamination

    Sun Pharmaceutical is recalling Niacin Extended-Release Tablets nationwide due to microbial contamination found in manufacturing equipment. Affected lot numbers expire in June and July 2025.

    Product
    NIACIN — NIACIN (NIACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0263-2024·2024-01-31

    Prescription Drug Cinacalcet Tablets Recalled for Manufacturing Contamination

    Sun Pharmaceutical is recalling 1,728 bottles of Cinacalcet Tablets 60mg due to microbial contamination found in manufacturing equipment. No illnesses have been reported.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0811-2024·2024-01-31

    MRI Liquid Cooling Cabinet may have incorrect electrical shock warning label

    Some Philips Intera 1.5T MRI systems have an incorrect warning label on the Liquid Cooling Cabinet that fails to properly warn service personnel of electrical shock hazards.

    Product
    Intera 1.5T, Model No. 781195
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0268-2024·2024-01-31

    Mesalamine Tablets Recalled for Manufacturing Equipment Microbial Contamination

    Sun Pharmaceutical recalls 10,690 bottles of Mesalamine tablets nationwide due to microbial contamination found in manufacturing equipment. Patients should contact their healthcare provider.

    Product
    MESALAMINE — MESALAMINE (MESALAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0266-2024·2024-01-31

    Prescription Drug Recall: Lurasidone Hydrochloride Tablets for Microbial Contamination

    Sun Pharmaceutical is recalling 11,400 bottles of Lurasidone Hydrochloride 60mg tablets due to microbial contamination in manufacturing equipment. Patients taking this medication should contact their doctor or pharmacist.

    Product
    LURASIDONE HYDROCHLORIDE — LURASIDONE HYDROCHLORIDE (LURASIDONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0812-2024·2024-01-31

    MRI Cooling Cabinet Has Incorrect Electrical Warning Label

    Cooling cabinets in Philips MRI systems have defective electrical warning labels with incorrect colors and a missing high voltage warning symbol, creating electrical shock risk for service personnel.

    Product
    SmartPath to dStream for 1.5T, Model No. 781260, 782112
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0810-2024·2024-01-31

    Medical Device MRI Cooling Cabinet Warning Label Missing High-Voltage Symbol

    Philips Ingenia Ambition X MRI systems contain an incorrect warning label on the cooling cabinet. The label is missing high-voltage warning symbols, creating a potential electrical shock risk for service personnel.

    Product
    Ingenia Ambition X, Model No. 782109
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0807-2024·2024-01-31

    MRI system warning label defect presents electrical shock risk to service personnel

    Achieva 1.5T MR systems have incorrect warning labels on the Liquid Cooling Cabinet, missing the high voltage warning symbol. This presents a potential electrical shock risk for service personnel.

    Product
    Achieva 1.5T, Model No. 781178, 781196, 781296
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0259-2024·2024-01-31

    Fluocinolone Acetonide Ear Drops Recalled Due to Failed Specification

    Glenmark Pharmaceuticals is recalling Fluocinolone Acetonide Oil 0.01% ear drops due to failed excipient specifications. The affected lots nationwide do not meet required quality standards for isopropyl alcohol content.

    Product
    FLUOCINOLONE ACETONIDE — FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0809-2024·2024-01-31

    Philips MRI system recalled for incorrect electrical warning label

    Philips Achieva 3.0T MRI systems have an incorrect electrical warning label on the liquid cooling cabinet, missing the high voltage symbol and proper yellow background. This presents a risk of electrical shock to service personnel.

    Product
    Achieva 3.0T, Model No. 781177
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0271-2024·2024-01-31

    Zolpidem Tartrate Tablets Recalled Due to Manufacturing Equipment Contamination

    Sun Pharmaceutical is recalling approximately 1220 bottles of Zolpidem Tartrate Extended-Release 6.25 mg tablets distributed nationwide due to microbial contamination detected in manufacturing equipment.

    Product
    ZOLPIDEM TARTRATE — ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0257-2024·2024-01-31

    Benzonatate Capsules Nationwide Recall for Above-Specification Assay Results

    Amerisource Health Services is recalling 6,344 cartons of Benzonatate 100 mg capsules nationwide due to assay results that were slightly above specification. No illnesses or injuries have been reported.

    Product
    BENZONATATE — BENZONATATE (BENZONATATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0778-2024·2024-01-31

    Market Basket Organic Trek Mix recalled for vegetation contamination

    Market Basket Organic Trek Mix (11oz and 14oz bags) is being recalled due to the presence of stem and vegetation foreign material. The affected lot #23354 was distributed to Maryland, Oregon, and Massachusetts.

    Product
    Market Basket, Organic Trek Mix, 11oz & 14oz. plastic resealable bags . 8/11oz & 12/14oz bags per case.
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·24V053000·2024-01-30

    Nissan Murano quarter glass panels can detach from the vehicle

    Nissan is recalling certain 2024 Murano vehicles because incorrect primer may have been used on the quarter glass, allowing the left and right panels to detach and become a road hazard.

    Product
    NISSAN — NISSAN MURANO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V054000·2024-01-30

    Travel trailer cooktop control boards can overheat and cause fire

    Winnebago is recalling certain 2022-2023 Micro Minnie, Micro Minnie FLX, Hike 200 and Minnie travel trailers because the LED backlight circuit board in the cooktop range may fail and overheat.

    Product
    WINNEBAGO — WINNEBAGO HIKE, MICRO MINNIE, MICRO MINNIE FLX, MINNIE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·24V051000·2024-01-30

    Tesla brake warning light font size fails federal display standard

    Tesla is recalling certain 2012-2024 vehicles because the Brake, Park and ABS warning lights display at an incorrect font size, failing FMVSS 105 and 135. A free over-the-air update fixes it.

    Product
    TESLA — TESLA MODEL S, MODEL X, MODEL 3, MODEL Y
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V050000·2024-01-26

    Coachmen Prism Motorhomes Recalled for Furnace Carbon Monoxide Risk

    Forest River is recalling 2023-2024 Coachmen Prism motorhomes because a furnace defect may allow carbon monoxide to enter the cabin, posing a risk of injury or death.

    Product
    COACHMEN — COACHMEN PRISM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V046000·2024-01-26

    Winnebago Recalls 2024 Access Travel Trailers Due to Brake Wiring Defect

    Winnebago is recalling 2024 Access travel trailers because an incorrectly wired breakaway switch may prevent emergency trailer brakes from activating if the trailer detaches.

    Product
    WINNEBAGO — WINNEBAGO ACCESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V048000·2024-01-26

    Blue Bird Recalls 2024 Vision Buses Due to Parking Brake Defect

    Blue Bird is recalling 2024 Vision Transit and School Buses because the parking brake release mechanism may malfunction, potentially allowing the vehicle to roll away.

    Product
    BLUE BIRD — BLUE BIRD VISION TRANSIT BUS, VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V049000·2024-01-26

    Tiffin Convoy solar panel brackets may crack and release the panel

    Tiffin is recalling certain 2023-2024 Convoy and GH-1 motorhomes because the bracket securing the roof solar panel may crack and break, allowing the panel to detach. 67 units affected.

    Product
    TIFFIN — TIFFIN GH1, CONVOY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24E005000·2024-01-26

    Renogy Recalls 12V, 24V, and 48V Battery Packs Due to Fire Risk

    Renogy is recalling specific battery packs because relay contactors may become stuck, increasing the risk of fire during charging.

    Product
    ELECTRICAL SYSTEM:12V/24V/48V BATTERY recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V045000·2024-01-26

    2024 Coachmen Travel Trailers Recalled for Missing Tail Light Bezels

    Forest River is recalling 2024 Coachmen Clipper and Viking travel trailers because the tail light bezel may be missing, reducing visibility and increasing crash risk.

    Product
    COACHMEN — COACHMEN VIKING, CLIPPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V042000·2024-01-25

    Terex Recalls 2023 Aerial Work Platforms Due to Bolt Tightening Defect

    Terex is recalling 2023 Optima and XT Pro vehicles because improperly tightened boom rotation bearing bolts may fail, causing the boom to fall and increasing injury risk.

    Product
    TEREX ADVANCE — TEREX ADVANCE, TEREX HRX55, HRX50, TC55, XT PRO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·24092·2024-01-25

    Pacific Cycle Recalls Ascend Electric Bikes Due to Fire Hazard

    Pacific Cycle is recalling about 1,700 Ascend Cabrillo and Minaret electric bikes because the battery charging wiring harness may overheat and catch fire while charging. The company has received three fire reports, including one causing second-degree burns.

    Product
    Ascend Cabrillo and Minaret Electric Bikes
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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