The Recall Desk

Archive

October 2023 recalls

491 recalls were announced in October 2023.

What the numbers show

Critical
19
Severe
138
High
300
Moderate
34

Of the 491 recalls this month scored against our rubric, 4% are Critical, 28% are Severe.

1–100 of 491

  • SevereNHTSA·23V730000·2023-10-31

    Triumph Rocket 3 rear brake master cylinders may extend stopping distance

    Triumph is recalling certain 2020-2024 Rocket 3 motorcycles because the rear brake master cylinder may fail to move fluid properly, requiring an extended distance to stop. 3,557 units affected.

    Product
    TRIUMPH — TRIUMPH ROCKET 3 R, ROCKET 3 GT, ROCKET 3 TFC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23T007000·2023-10-31

    Toyo Recalls Open Country and Extensa Tires Due to Mold Defect

    Toyo Tire Holdings is recalling certain Open Country and Extensa tires because they may have been produced with the wrong mold, risking tread or sidewall detachment.

    Product
    TIRES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·055-2023·2023-10-31

    Q'Delicia Recalls Ready-to-Eat Empanada Products Produced Without Inspection

    Q'Delicia is recalling ready-to-eat empanada products produced without federal inspection. The products were distributed in Florida and may not be safe for consumption.

    Product
    Q'Delicia Recalls Ready-To-Eat Empanada Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·23V726000·2023-10-30

    Starcraft and Glaval Transit Buses Recalled for Air Compressor Defect

    Forest River Bus is recalling certain 2021-2023 Starcraft and Glaval transit buses because the air conditioning compressor may contact the sway bar, risking loss of steering control.

    Product
    STARCRAFT BUS — STARCRAFT BUS, GLAVAL BUS ALLSTAR XL, ALLSTAR XLT, CONCORDE II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·054-2023·2023-10-30

    Olymel Recalls Ready-to-Eat Ham Products Imported Without Reinspection

    Olymel is recalling approximately 11,016 pounds of ready-to-eat ham products that were imported into the United States without the required import reinspection.

    Product
    Olymel Recalls Ready-To-Eat Ham Products Imported Without the Benefit of Import Reinspection
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·23V727000·2023-10-27

    Ford Mustang Brake Fluid Warning System Software Recall

    Ford is recalling 2020-2023 Mustang vehicles because the brake fluid level sensor may fail to illuminate the warning light when brake fluid is low. Drivers could operate the vehicle with insufficient brake fluid, reducing braking performance and increasing crash risk.

    Product
    FORD — FORD MUSTANG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V719000·2023-10-26

    Mazda Recalls 2024 CX-90 Plug-in Hybrids for Software Error

    Mazda is recalling 2024 CX-90 plug-in hybrid vehicles because a software error may cause the engine and electric motor to shut down unexpectedly, resulting in a loss of drive power.

    Product
    MAZDA — MAZDA CX-90
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23E084000·2023-10-26

    Akron Brass Recalls Vehicle Multiplex Systems Due to Fire Risk

    Weldon Division of Akron Brass is recalling 8x16 Input-Output Node Vehicle Multiplex Systems because a wiring failure could cause overloaded circuits and fire.

    Product
    ELECTRICAL SYSTEM:WIRING recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·24013·2023-10-26

    Best Buy Recalls Insignia Pressure Cookers Due to Burn Hazard

    Best Buy is recalling about 930,000 Insignia pressure cookers because incorrect volume markings on the inner pot can cause consumers to overfill the unit, leading to hot food and liquids being ejected and causing burn injuries.

    Product
    Insignia pressure cookers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V722000·2023-10-26

    New Flyer Transit Buses Recalled for Transmission Yoke Separation Risk

    New Flyer is recalling 2019-2024 transit buses because the transmission yoke may separate, causing a sudden loss of drive power and increasing crash risk.

    Product
    NEW FLYER — NEW FLYER XN40, XN35, XD35, XD40
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V724000·2023-10-26

    Kia Recalls 2015-2019 Soul EV for Parking Mechanism Defect

    Kia is recalling 2015-2019 Soul EV vehicles because a damaged parking mechanism may cause unintended movement. Dealers will update software to fix the issue.

    Product
    KIA — KIA SOUL EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V717000·2023-10-26

    Kenworth W900 and T800 Vehicles Recalled for Unsecured Seat Belt Attachment

    Certain 2018-2024 Kenworth W900 and T800 vehicles may have an additional spacer in the seat belt attachment, causing an unsecured connection. This could prevent the seat belt from properly restraining an occupant during a crash.

    Product
    KENWORTH — KENWORTH T800, W900, T800B, T660
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V720000·2023-10-26

    2022 Toyota Highlander Front Bumper Covers May Detach During Operation

    Toyota is recalling certain 2020-2023 Highlander and Highlander Hybrid vehicles because the front bumper covers may come loose or detach during normal operation, potentially becoming a road hazard.

    Product
    TOYOTA — TOYOTA HIGHLANDER, HIGHLANDER HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V718000·2023-10-26

    2024 Mazda MAZDA3 and CX-90 Recalled for Camera Display Failure

    Mazda is recalling 2024 MAZDA3 and CX-90 vehicles due to a software error that prevents camera images from displaying, which fails federal rear visibility requirements and increases crash risk.

    Product
    MAZDA — MAZDA MAZDA3, CX-90
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V716000·2023-10-26

    Third-row seatbelt buckle defect in 2022–2024 Jeep Wagoneer models

    Chrysler is recalling 2022–2024 Jeep Wagoneer and Grand Wagoneer vehicles because the third-row seatbelt buckles may not fasten properly. Unfastened seatbelts could increase injury risk during a crash.

    Product
    JEEP — JEEP WAGONEER, GRAND WAGONEER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V725000·2023-10-26

    2023-2024 Nissan Z: Loose Fasteners May Prevent Pop-Up Hood Activation

    Certain 2023-2024 Nissan Z vehicles have loose fasteners in the front bumper reinforcement that may prevent the pop-up engine hood from activating, increasing injury risk in frontal pedestrian crashes. Dealers will tighten the fasteners free of charge.

    Product
    NISSAN — NISSAN Z
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24706·2023-10-26

    Bobcat and Kubota Stand-On Zero-Turn Lawnmowers Recalled for Crash and Laceration Hazard

    Doosan Bobcat North America is recalling about 830 Bobcat- and Kubota-branded stand-on zero-turn lawnmowers due to a steering system defect that can prevent the control levers from returning to neutral, disabling the operator presence switch and stopping mechanism. This poses crash and laceration hazards.

    Product
    Bobcat-branded and Kubota-branded stand-on zero-turn lawnmowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V723000·2023-10-26

    2024 Subaru Forester Water Pipe Bolts May Loosen, Risk Fire

    Certain 2024 Subaru Forester models have engine water pipe attachment bolts that may loosen, allowing the pipe to leak coolant onto hot engine components and create a fire risk.

    Product
    SUBARU — SUBARU FORESTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24705·2023-10-26

    Kawasaki Lawn Mower Engines Recalled Due to Fire and Burn Hazards

    Kawasaki Motors is recalling about 954 lawn mower engines used in Ariens, Gravely, Husqvarna, John Deere, and RedMax brand equipment. A damaged fuel tube due to improper repair workmanship could leak fuel and cause fire or burn injuries.

    Product
    Kawasaki Lawn Mower Engines used in Ariens, Gravely, Husqvarna, John Deere and RedMax brand lawn mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·24014·2023-10-26

    Cosco Jump, Spin & Play Activity Centers Recalled for Fall and Injury Hazards

    Dorel Juvenile Group is recalling about 115,700 Cosco Jump, Spin & Play Activity Centers because the straps can detach or break while a child is in the seat, posing fall and injury risks. The company has received 141 reports of strap failures, including 38 minor injuries.

    Product
    Cosco Jump, Spin & Play Activity Centers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0288-2024·2023-10-25

    Mooncakes Recalled Due to Undeclared Egg Allergen

    Sheng Kee Bakery mooncakes recalled for undeclared egg allergen across CA, IL, TX, GA, WA, and NJ. Consumers with egg allergies should not consume.

    Product
    Small 12 -3 Flavor Assorted Mooncake Gift Box Small 12- 4 Flavor Assorted Mooncake Gift Box Small 12- 6 Flavor Assorted Mooncake Tin Gift Box Small 6- 3 Flavor Assorted Mooncake Gift Box Small 9- 3 Flavor Assorted Mooncake Gift Box Assorted Large 4 Mooncake Gift Box
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0094-2024·2023-10-25

    Sapphire Infusion Pumps recalled for software air-detection failure

    Sapphire Infusion Pumps with software revisions 16.10.1 or 16.10.2 may fail to detect air in the infusion line, potentially causing life-threatening air embolism. Approximately 1,383 units have been distributed nationwide.

    Product
    Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0289-2024·2023-10-25

    Sheng Kee Bakery Mooncakes Recalled for Undeclared Egg Allergen

    Sheng Kee of California is recalling Large 4-Date Mooncake Gift Boxes due to undeclared egg allergen. The product was distributed to multiple U.S. states.

    Product
    Large 4- Date Mooncake Gift Box
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0046-2024·2023-10-25

    TheraBreath for Kids Oral Rinse Recalled for Yeast Contamination

    FDA recalls TheraBreath for Kids Oral Rinse due to microbial contamination identified as Candida parapsilosis yeast. Approximately 5,316 bottles distributed nationwide are affected.

    Product
    TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry Splash, UPC 6 97029 70000 6, manufactured for Church & Dwight Co, Inc., Ewing, NJ 08628
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0047-2024·2023-10-25

    FDA Recalls Sucralfate Oral Suspension Due to Bacillus Cereus Contamination

    VistaPharm is recalling 180 bottles of Sucralfate Oral Suspension nationwide due to Bacillus cereus contamination, a Class I recall. The affected lot (810300, expiring October 2023) should not be used.

    Product
    SUCRALFATE — SUCRALFATE (SUCRALFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V714000·2023-10-25

    Nova Bus Recalls 2015-2019 LFS Models Due to Seat Hardware Defect

    Nova Bus is recalling 2015-2019 LFS and LFS Artic transit buses because incorrectly installed seat hardware may allow seats to detach, increasing injury risk.

    Product
    NOVA BUS — NOVA BUS LFS ARTIC, LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0075-2024·2023-10-25

    Olympus High-Flow Insufflation Unit Model UHI-4 Recalled for Cardiac Complications

    Olympus recalls the UHI-4 High-Flow Insufflation Unit used in laparoscopic surgery after reports of patients experiencing cardiac arrhythmias and short cardiac arrests during procedures. Incidents may result from over insufflation of the abdominal cavity.

    Product
    Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0292-2024·2023-10-25

    Large 4-Red Bean Mooncake Gift Box Recalled for Undeclared Egg Allergen

    Sheng Kee Bakery is recalling Large 4-Red Bean Mooncake Gift Boxes distributed in six states due to undeclared egg allergen. Consumers with egg allergies should not consume the product.

    Product
    Large 4- Red Bean Mooncake Gift Box
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0293-2024·2023-10-25

    Oasis Mediterranean Cuisine Hommus Chips Recalled Due to Undeclared Sesame

    La Perla Inc is recalling Oasis Mediterranean Cuisine Thin & Crunchy Sea Salt Hommus Chips because sesame is not declared on the label. The product was distributed in Ohio with a Best By date of 12/21/23.

    Product
    Oasis Mediterranean Cuisine - Thin & Crunchy Sea Salt Hommus Chips packaged in 6oz printed bags, 12 bags per case.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0291-2024·2023-10-25

    Lotus Pine Nut Mooncakes Recalled for Undeclared Egg Allergen

    Sheng Kee Bakery is recalling Large 4-Lotus Pine Nut Mooncake Gift Boxes because they contain undeclared egg, a major allergen. The product was distributed in California, Illinois, Texas, Georgia, Washington, and New Jersey.

    Product
    Large 4- Lotus Pine Nut Mooncake Gift Box
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0049-2024·2023-10-25

    Betaxolol Hydrochloride tablets recalled due to oxycodone contamination

    KVK-Tech's Betaxolol Hydrochloride tablets (10 mg, lot 17853A) are being recalled nationwide due to potential contamination with oxycodone tablets. Patients should stop using affected bottles immediately and contact their healthcare provider.

    Product
    BETAXOLOL HYDROCHLORIDE — BETAXOLOL HYDROCHLORIDE (BETAXOLOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0286-2024·2023-10-25

    Sweet Potatoes Recalled Due to Processing Equipment Failure

    Moody Dunbar Inc recalls HEB and Sysco brand sweet potatoes because a sterilization monitoring chart malfunctioned during production, preventing verification of adequate heat treatment.

    Product
    Sweet Potatoes sold under the brand names: HEB CUT SWEET POTATOES IN LIGHT SYRUP NET WT. 29 OZ (1 LB 13 OZ) 822g MADE WITH PRIDE AND CARE FOR HEB, SAN ANTONIO, TEXAS 78204 UPC 0 41220 45933 9 & SYSCO Classic Cut Sweet Potatoes NET WT/PESO NETO 108 OZ (6 LB 12 OZ) 3.06 kg DISTRIBU
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0295-2024·2023-10-25

    Safeway Recalls Diced Organic Butternut Squash for E. Coli O45

    Safeway Fresh Foods is recalling 32-oz. Diced Organic Butternut Squash distributed exclusively to Costco in Washington DC, Maryland, Pennsylvania, and Virginia due to potential E. coli O45 contamination.

    Product
    Sunnyside Farms, diced Organic Butternut Squash , 32-oz. , plastic tray, 6 trays per case, Perishable Keep Refrigerated .
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0297-2024·2023-10-25

    Sweet Corn Pancakes recalled for undeclared wheat, soy, and yellow #5 allergens

    Tama Corporation recalls PAISA Sweet Corn Pancakes for undeclared wheat, soy, and yellow #5 allergens. Consumers with allergies to these substances should not consume the product.

    Product
    PAISA Sweet Corn Pancakes, Cachapas de Maiz, NET WT. 24 Oz., 5 units, KEEP REFRIGERATED
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0057-2024·2023-10-25

    Cefuroxime Injectable Syringes Recalled for Lack of Sterility Assurance

    Pine Pharmaceuticals is recalling 4,972 syringes of Cefuroxime injectable medication due to lack of assurance of sterility. The compounded antibiotic was distributed nationwide.

    Product
    Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0059-2024·2023-10-25

    Compounded Lidocaine-Phenylephrine Injectable Recalled Due to Sterility Assurance Issues

    Pine Pharmaceuticals is recalling 9,673 vials of compounded lidocaine-phenylephrine injectable due to lack of assurance of sterility. Affected lots were distributed nationwide.

    Product
    Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0296-2024·2023-10-25

    Kraft Singles American Cheese Recalled for Plastic Film Fragment Risk

    Heinz is recalling Kraft Singles American Cheese because thin plastic film fragments may remain on cheese slices after unwrapping. Affected product was distributed nationwide and in Puerto Rico.

    Product
    Kraft Singles American Pasteurized Prepared Cheese product, 24 individually wrapped slices in flexible film per pack, net wt. per pack 16oz, keep refrigerated. Single pack is sold at retail. Case UPC 0 00 2100007180 7; Single Pack UPC 0 2100061526 1: Each case contains 27 packs
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0294-2024·2023-10-25

    Mint chip ice cream recalled for undeclared wheat, soy, and coconut

    Katie's Korner Inc. is recalling 35 units of 3-gallon mint chip ice cream due to undeclared wheat, soy, and coconut. Consumers with allergies to these ingredients should not consume the product.

    Product
    3 Gallon, plastic container of mint chip flavored ice cream
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0055-2024·2023-10-25

    FDA Recalls Compounded Ophthalmic Solution Due to Sterility Concerns

    Pine Pharmaceuticals recalls Tropi-Phen ophthalmic solution due to lack of sterility assurance. The 15 mL droppers were distributed nationwide and customers should not use affected lots.

    Product
    Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0058-2024·2023-10-25

    FDA Recalls Compounded Moxifloxacin Syringes for Lack of Sterility Assurance

    Pine Pharmaceuticals recalls 2,176 syringes of compounded moxifloxacin nationwide due to inadequate sterility assurance. The product was distributed to healthcare providers and patients.

    Product
    Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0051-2024·2023-10-25

    Vancomycin Intraocular Injection Recalled Due to Sterility Assurance Failure

    Pine Pharmaceuticals is recalling 26 vials of Vancomycin 1 MG/0.1 ML intraocular injection (Lot #69985) due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0115-2024·2023-10-25

    HydroPICC Catheter Kit Recalled for Missing Safety Warnings

    Access Vascular recalls HydroPICC 5Fr Dual Lumen Maximal Barrier Kits due to incorrect Instructions For Use missing warnings about adult-use only and vessel sizing risks. No adverse events reported.

    Product
    HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0122-2024·2023-10-25

    Functional MRI Software Bug May Cause DICOM Export Data Mismatch

    A software bug in Functional MR V1.0 can cause file contents and descriptions to not match when exporting multiple regions of interest in DICOM format, potentially leading to misinterpretation of clinical imaging data.

    Product
    Functional MR V1.0
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0065-2024·2023-10-25

    Foscarnet Sodium Injectable Recalled Due to Lack of Sterility Assurance

    Pine Pharmaceuticals is recalling Foscarnet Sodium 2.4mg/0.1 mL injectable syringes nationwide due to lack of assurance of sterility. No illnesses or injuries have been reported.

    Product
    Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0120-2024·2023-10-25

    Surgical Instrument Shears Recalled Due to Incomplete Packaging Seal

    MEDLINE ReNewal Harmonic ACE+7 surgical shears may have incomplete seals on packaging trays. Approximately 18 units were distributed in the United States. Affected products should not be used.

    Product
    MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0064-2024·2023-10-25

    Compounded Intranasal Lidocaine-Oxymetazoline Solution Recalled Due to Sterility Assurance

    Pine Pharmaceuticals is recalling 860 syringes of intranasal lidocaine-oxymetazoline solution distributed nationwide due to lack of sterility assurance. Lot 67808 expired 10/23/2023.

    Product
    Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0052-2024·2023-10-25

    Endophth Kit Recalled Due to Lack of Sterility Assurance

    Pine Pharmaceuticals recalled an Endophth Kit (Vancomycin/Ceftazidime injectable) distributed nationwide due to lack of assurance of sterility. The recall affects 201 kits from lot 69986 (expires 11/15/2023).

    Product
    Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0116-2024·2023-10-25

    DeRoyal Head and Neck Surgical Kits Recalled for Damaged Syringe Luer Tip

    DeRoyal Industries is recalling 32 surgical procedure kits containing syringes with potentially damaged luer tips that could compromise the sterile packaging barrier. The kits were distributed in Pennsylvania.

    Product
    DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·23V715000·2023-10-25

    Porsche 911 GT3 air bag control unit may deploy unnecessarily in crash

    Porsche is recalling certain 2021-2024 911 models equipped with optional full bucket seats due to a potential air bag control defect. Unnecessary air bag deployment during a crash could increase injury risk.

    Product
    PORSCHE — PORSCHE 911 GT3, 911 TURBO, 911 TURBO S, 911 GT3 RS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0062-2024·2023-10-25

    Lidocaine eye drops recalled due to lack of sterility assurance

    Pine Pharmaceuticals is recalling Lidocaine HCl 4% ophthalmic solution due to lack of sterility assurance. The affected product was distributed nationwide in 1,598 single-use droppers.

    Product
    Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0060-2024·2023-10-25

    TPC Drops Ophthalmic Solution Recalled for Lack of Sterility Assurance

    Pine Pharmaceuticals is recalling TPC Drops ophthalmic solution due to lack of assurance of sterility. The recall affects 1693 droppers distributed nationwide.

    Product
    TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0125-2024·2023-10-25

    Wrist and Thumb Orthosis Recalled for Undeclared Latex

    North Coast Medical Inc is recalling the Gladiator Wrist & Thumb Orthosis because the thumb strap may contain latex that is not declared on the product label. People with latex allergies are at risk.

    Product
    Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654 (Large/Left), NC86655 (Large/Right), NC86656 (X-Large/Left), and NC86657 (X-Large/Right)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0114-2024·2023-10-25

    HydroPICC Catheter Kit Recall: Missing Critical Use-Restriction Warnings

    Access Vascular is recalling HydroPICC Dual Lumen Catheter kits with incorrect instruction documents that omit critical warnings about adult-only use and vessel sizing. No adverse events have been reported.

    Product
    HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0061-2024·2023-10-25

    Calcium Chloride IV Solution Recalled Due to Sterility Assurance Concerns

    Pine Pharmaceuticals recalls Calcium Chloride IV Solution for Intravenous Injection, 20 mg/mL (lot 70101), due to lack of assurance of sterility. Approximately 130 units were distributed nationwide.

    Product
    Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0112-2024·2023-10-25

    Monoject tuberculin syringes incompatible with certain IV connectors

    Cardinal Health is recalling Monoject tuberculin syringes because the conical tip is incompatible with certain needleless IV connectors.

    Product
    Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0056-2024·2023-10-25

    Intraocular Moxifloxacin Injection Recalled Due to Sterility Assurance Issues

    Pine Pharmaceuticals is recalling 2,484 syringes of Moxifloxacin intraocular injection nationwide due to lack of sterility assurance in the compounded product.

    Product
    Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0.1mL) Syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0053-2024·2023-10-25

    Calcium Gluconate Ophthalmic Irrigation Solution Recall Due to Sterility Concerns

    Pine Pharmaceuticals is recalling Calcium Gluconate Ophthalmic Irrigation Solution 1% (Lot #69802) due to lack of sterility assurance. The 128 bags distributed nationwide may pose infection risk if used.

    Product
    Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0048-2024·2023-10-25

    Doxil Chemotherapy Drug Recalled for Improper Storage Temperature During Shipment

    Baxter Healthcare is recalling 472 vials of Doxil chemotherapy medication due to exposure to temperatures exceeding labeled storage conditions during transportation. Affected vials were distributed nationwide.

    Product
    DOXIL — DOXIL (DOXORUBICIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0113-2024·2023-10-25

    Stryker Tornier Reversed Glenoid Baseplate Recalled for Manufacturing Defect

    One lot of Stryker Tornier Perform Reversed Glenoid Baseplate components was manufactured with incorrect 6mm spacers instead of 3mm, preventing proper assembly. The defect affects 30 units distributed across ten US states.

    Product
    stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Drugs)·D-0050-2024·2023-10-25

    Compounded Bevacizumab Injectable Syringes Recalled for Sterility Assurance

    Pine Pharmaceuticals is recalling approximately 2,862 syringes of compounded Bevacizumab 1.25 MG/0.05 ML Solution for Injection due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0063-2024·2023-10-25

    FDA Recalls Tropi-Phen Ophthalmic Solution Due to Sterility Assurance Failure

    Pine Pharmaceuticals has recalled 662 dropper units of Tropi-Phen ophthalmic solution due to lack of sterility assurance. The affected lots were distributed nationwide.

    Product
    Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0054-2024·2023-10-25

    Calcium Gluconate Inhalation Solution Recalled Due to Sterility Concerns

    Pine Pharmaceuticals is recalling Calcium Gluconate 2.5% inhalation solution due to lack of sterility assurance. Patients should stop using affected syringes and contact their healthcare provider.

    Product
    Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0044-2024·2023-10-25

    Sun Pharmaceutical Bupropion Extended-Release Tablets Recalled for Failed Dissolution

    Sun Pharmaceutical is recalling Bupropion Hydrochloride Extended-Release Tablets (150 mg), lot HAD0360A, due to failed dissolution specifications. The 144 bottles were distributed nationwide and may not dissolve at the intended rate.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0043-2024·2023-10-25

    Ophthalmic Solution Recalled Due to Subpotent Ketorolac Levels

    MYDRIATIC-4 ophthalmic solution is being recalled because ketorolac levels fell below the required 90-110% specification. The product was distributed to physician offices nationwide.

    Product
    MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0118-2024·2023-10-25

    Medline ReNewal Ligasure Maryland Jaw Sealer devices recalled for incomplete packaging seals

    Medline is recalling 58 units of ReNewal Ligasure Maryland Jaw Sealer electrosurgical instruments due to incomplete seals on packaging trays that may allow contamination during reprocessing.

    Product
    MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10 Generator, REF LF1944CR. electrosurgical instrument
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0121-2024·2023-10-25

    SenSight Connector Plug Recalled for Use By Date Label Discrepancy

    Medtronic Neuromodulation is recalling 65 units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date printed on the device label. The company is requesting return of affected units.

    Product
    SenSight Connector Plug, Model Number B31061.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0119-2024·2023-10-25

    MEDLINE Electrosurgical Instruments Recalled for Incomplete Packaging Seals

    MEDLINE INDUSTRIES is recalling ReNewal Ligasure Sealer/Divider electrosurgical instruments due to incomplete seals on packaging trays. The recall affects 268 units distributed in the United States.

    Product
    MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF4418CR. electrosurgical instrument
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0117-2024·2023-10-25

    Electrosurgical Devices Recalled for Incomplete Packaging Tray Seal

    Medline is recalling 11 reprocessed Covidien LigaSure and Ethicon Harmonic electrosurgical devices due to incomplete seals on their packaging trays.

    Product
    MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF1844CR. electrosurgical instrument
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0045-2024·2023-10-25

    Over-the-counter drugs from Family Dollar recalled for improper storage

    Dollar Tree Distribution recalled approximately 4.3 million over-the-counter drug products sold by Family Dollar stores nationwide after discovering they were stored outside of labeled temperature requirements.

    Product
    Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V713000·2023-10-24

    Mack Recalls 2024 LR Trucks Due to Loose Steering Fasteners

    Mack Trucks is recalling 2024 LR vehicles because loose steering fasteners may cause loss of control. Owners should not drive until repaired.

    Product
    MACK — MACK LR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V712000·2023-10-23

    Midwest Automotive Designs Recalls 2017-2022 Motorhomes Due to Wheel Defect

    Midwest Automotive Designs is recalling 2017-2022 motorhomes because alloy wheels may crack and fail, increasing crash risk.

    Product
    MIDWEST AUTOMOTIVE DESIGN — MIDWEST AUTOMOTIVE DESIGN ULTIMATE PRESIDENTIAL, LUXE CRUISER, ULTIMATE CLUB J
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·053-2023·2023-10-23

    Capitology LLC Recalls Ineligible Pork Chicharrones Imported from Honduras

    Capitology LLC is recalling 4,679 pounds of pork chicharrones imported from Honduras because the country is ineligible to export pork to the U.S.

    Product
    Capitology, LLC Recalls Ineligible Pork Chicharrones Products Imported from Honduras
    Category
    Food
    Distribution
    5 states
  • SevereUSDA FSIS·052-2023·2023-10-20

    Del Valle Recalls Raw Pork Chorizo Produced Without Federal Inspection

    Del Valle Import and Export LLC is recalling raw pork chorizo produced without federal inspection and bearing a false mark of inspection.

    Product
    Del Valle Import and Export LLC Recalls Pork Chorizo Products Produced without Benefit of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V706000·2023-10-20

    Coachmen Concord Motorhomes Recalled for Driveline Angle Defect

    Forest River is recalling 2023-2024 Coachmen Concord motorhomes because an incorrect driveline angle may cause rear wheel lockup and increase crash risk.

    Product
    COACHMEN — COACHMEN CONCORD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V707000·2023-10-20

    BMW Recalls 157,796 Vehicles for Potential Engine Stall Risk

    BMW is recalling 157,796 vehicles from 2010-2012 because aluminum bolts securing the VANOS unit may loosen or break, potentially causing an engine stall and increasing crash risk.

    Product
    BMW — BMW X5, Z4, 3 SERIES, 1 SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V711000·2023-10-20

    New Flyer Transit Buses Recalled for Incorrect Weight Rating Labels

    New Flyer is recalling 2021-2023 transit buses because incorrect weight rating labels may allow vehicles to be overloaded, increasing crash risk.

    Product
    NEW FLYER — NEW FLYER XE40, XD35, XDE35, XD60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V710000·2023-10-20

    2024-2025 Lion School Buses Recalled for Brake System Installation Defect

    Lion Electric is recalling certain 2024-2025 LionC school buses due to incorrect installation of anti-lock brake system pneumatic valve connections and rear wheel speed sensors, which can cause wheel lockup or loss of vehicle control.

    Product
    LION — LION LIONC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalCPSC·24011·2023-10-19

    Fortress Safe Biometric Gun Safes: Unauthorized Access and Risk of Death

    Xpedition LLC is recalling approximately 61,000 biometric gun safes because the biometric locks can be opened by unauthorized users, posing serious injury and death risks. One death has been reported in a recent lawsuit.

    Product
    Biometric Gun Safes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·051-2023·2023-10-19

    USDA Recalls Ineligible Imported Pork Chicharrones from East Coast Food Distributors

    USDA FSIS is recalling approximately 7,767 pounds of pork chicharrones imported from Colombia because the country is ineligible to export meat to the U.S.

    Product
    East Coast Food Distributors, Inc. Recalls Ineligible Pork Chicharrones Products Imported from Colombia
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·050-2023·2023-10-19

    Aunt Kitty's Recalls Canned Chicken Pot Pie Soup Due to Undeclared Soy

    Aunt Kitty's Foods Inc. is recalling canned chicken pot pie soup because it contains soy, a known allergen, that is not declared on the label.

    Product
    Aunt Kitty's Foods Inc — Aunt Kitty's Foods Inc. Recalls Canned Ready-to-Eat Chicken Pot Pie Soup Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·24704·2023-10-19

    Polaris RZR Recreational Off-Road Vehicles Recalled for Crash Hazard

    Polaris is recalling certain 2023 and 2024 RZR recreational off-road vehicles because an improperly routed brake line can contact the front wheels, causing brake loss and crashes. Consumers should immediately stop using the vehicles and contact a Polaris dealer for a free inspection and repair.

    Product
    Model Year 2023 RZR PRO XP and PRO XP 4 and Model Year 2024 RZR XP and XP 4 ROVs
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V702000·2023-10-19

    Altec Recalls 2023 Digger Derricks Due to Gearbox Defect

    Altec is recalling 2023 Digger Derricks because a defective brake flange casing may cause the turntable rotation gearbox to fail at high loads, increasing the risk of injury.

    Product
    ALTEC — ALTEC DIGGER DERRICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V701000·2023-10-19

    Alliance RV fifth wheel trailers recalled for loose solar electrical connection

    Alliance RV is recalling 2021-2023 Paradigm and Valor fifth wheel trailers because a wire connector in the solar panel electrical system may loosen and overheat, creating a fire risk.

    Product
    ALLIANCE RV — ALLIANCE RV VALOR, PARADIGM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V704000·2023-10-19

    2022-2024 Honda Civic power steering rack defect increases tire failure risk

    Replacement power steering racks in certain 2022-2024 Honda Civic vehicles may have been incorrectly assembled, allowing tires to chafe against the suspension and fail. This affects approximately 264,567 vehicles and increases crash risk.

    Product
    HONDA — HONDA CIVIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24010·2023-10-19

    Thomas & Friends Wooden Railway Troublesome Truck Toys Recalled for Choking and Magnet Ingestion

    Fisher-Price is recalling about 21,000 Thomas & Friends Wooden Railway Troublesome Truck train cars because the magnetic connector piece can detach, posing choking and magnet ingestion hazards.

    Product
    Thomas & Friends Wooden Railway Troublesome Truck & Crates and Thomas & Friends Wooden Railway Troublesome Truck & Paint
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V709000·2023-10-19

    2023 Jaguar I-PACE vehicles recalled for battery fire risk

    Jaguar is recalling 2019-2023 I-PACE vehicles due to battery overheating risk from an incomplete prior repair. Owners must park and charge outside until the software update is installed and for 30 days after.

    Product
    JAGUAR — JAGUAR I-PACE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0011-2024·2023-10-18

    Ginger Snap Milk Chocolate recalled for undeclared peanut allergen

    Dick Taylor Inc is recalling Ginger Snap Milk Chocolate due to undeclared peanut allergen. People with peanut allergies may experience serious allergic reaction if they consume this product.

    Product
    Ginger Snap Milk Chocolate, 2 oz wrapped
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0287-2024·2023-10-18

    Quaker Pancakes with Whole Grain Oats Recalled for Undeclared Soy Allergen

    Comercializadora Pepsico Mexico recalls Quaker Pancakes with Whole Grain Oats due to undeclared soy allergen. The product contains soy not listed on the label, creating a health risk for consumers with soy allergies.

    Product
    QUAKER PANCAKES WITH WHOLE GRAIN OATS, NET WT 15.97OZ (1LB)
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-0028-2024·2023-10-18

    FDA Recalls Fresenius 2008T Hemodialysis Systems Due to PCBA Leaching

    Fresenius Medical Care is recalling 703 units of the Fresenius 2008T Hemodialysis System nationwide due to potential PCBA (printed circuit board assembly) leaching from machine tubing.

    Product
    2008T Hemodialysis SYS, with CDX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0005-2024·2023-10-18

    FDA Recalls Fresenius 10mL Luer Lock Syringes Due to Leakage and Foreign Material

    Fresenius Medical Care is recalling 10mL syringes nationwide due to potential blood backfill leakage and foreign material. The recall affects 124,773 boxes of the devices.

    Product
    10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0032-2024·2023-10-18

    Hemodialysis Machines Recalled Due to Potential PCBA Leaching

    Fresenius Medical Care is recalling 733 hemodialysis machines nationwide due to potential printed circuit board material leaking from tubing.

    Product
    2008T HD SYS. CDX BLUESTAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0034-2024·2023-10-18

    Hemodialysis machines recalled due to potential circuit board material leaching

    Fresenius Medical Care is recalling 733 units of 2008T hemodialysis systems nationwide due to potential leaching of printed circuit board assembly material from tubing. No illnesses or injuries have been reported.

    Product
    2008T HD SYS. W/O CDX BLUESTAR
    Category
    Medical Device
    Distribution
    Distributed nationwide

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