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.

1–100 of 423

  • CriticalCPSC·23299·2023-09-29

    Future Motion Onewheel Electric Skateboards Recalled for Crash Hazard

    Future Motion is recalling approximately 300,000 Onewheel self-balancing electric skateboards because they can stop balancing and cause the rider to crash. Four deaths and dozens of injuries including head trauma, fractures, and paralysis have been reported.

    Product
    Onewheel Electric Skateboards (all models)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V658000·2023-09-29

    2024 Forest River Wildwood fifth wheels missing emergency exit

    Forest River is recalling certain 2024 Wildwood and Salem fifth wheels that may be missing a secondary emergency exit window, which could delay occupant egress in an emergency.

    Product
    FOREST RIVER — FOREST RIVER SALEM, WILDWOOD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V664000·2023-09-29

    2024 Brinkley RV Model G fifth wheel toy haulers recalled for fire risk

    Brinkley RV is recalling 2024 Model G fifth wheel toy haulers because the power control system uses undersized 10-gauge wire instead of 6-gauge wire, which may overheat and increase the risk of fire.

    Product
    BRINKLEY RV — BRINKLEY RV MODEL G
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V660000·2023-09-29

    Forest River Recalls 2024 Coachmen and Shasta Trailers for Fire Risk

    Forest River is recalling 2024 Coachmen and Shasta fifth wheel trailers because an incorrect fuse in the power distribution center may increase the risk of a fire.

    Product
    COACHMEN — COACHMEN, SHASTA BROOKSTONE, CHAPARRAL, PHOENIX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V661000·2023-09-29

    Kenworth and Peterbilt Trucks Recalled for Trailer Brake Timing Delay

    PACCAR is recalling certain 2020–2024 Kenworth and Peterbilt commercial trucks. Delayed trailer brake release can create trailer instability and increase crash risk.

    Product
    PETERBILT — PETERBILT, KENWORTH 536, T380, 548, T280
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V663000·2023-09-29

    Winnebago Revel motorhomes electrical cable fire risk recall

    Winnebago is recalling certain 2020–2024 Revel motorhomes because cables near the lithium batteries may contact battery hold-down brackets, damaging the cables and causing a short circuit that increases fire risk.

    Product
    WINNEBAGO — WINNEBAGO REVEL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V659000·2023-09-29

    Coachmen Prism and Concord Recalled for Incorrect Federal Placard Information

    Forest River is recalling 2021-2024 Coachmen Prism and 2023-2024 Concord vehicles because the Federal Placard may display incorrect seat belt counts, potentially leading to vehicle overloading.

    Product
    COACHMEN — COACHMEN PRISM, CONCORD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V655000·2023-09-28

    Diamond C Trailers Recall 2023-2024 Models Due to Winch Failure

    Diamond C is recalling 2023-2024 FMAX, SDX, and PX trailers because the spare tire winch may loosen or fail, increasing crash risk.

    Product
    DIAMOND C TRAILERS — DIAMOND C TRAILERS FMAX, PX, SDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V656000·2023-09-28

    Autocar Recalls Xpeditor and Legend Vehicles for Steering Defect

    Autocar is recalling 2022-2023 Xpeditor and 2023 Legend vehicles because a steering column bolt may not be secured, risking sudden loss of steering.

    Product
    AUTOCAR — AUTOCAR XPEDITOR, LEGEND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V657000·2023-09-28

    2023 Nissan Ariya Inverter Software May Cause Loss of Drive Power

    Nissan is recalling certain 2023 Ariya vehicles due to a potential inverter software defect that may cause an unexpected loss of drive power. The loss of drive power increases the risk of a crash.

    Product
    NISSAN — NISSAN ARIYA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23794·2023-09-28

    Secura Air Fryers Recalled Due to Fire and Burn Hazards

    Secura Inc. is recalling approximately 6,400 air fryers because a wire connection can overheat, posing fire and burn hazards. The company has received nine reports of units catching fire, burning, and smoking, though no injuries or property damage have been reported.

    Product
    Secura Air Fryers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V654000·2023-09-28

    2024 RAM 2500 Rearview Camera Display Software Malfunction Recall

    Chrysler recalls 2024 RAM 2500 vehicles due to radio software that may prevent the rearview camera from displaying. Loss of rearview visibility increases crash risk.

    Product
    RAM — RAM 3500, 2500, 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23E071000·2023-09-28

    Firefly Recalls Multiplex HC Relay Cards Due to Fire Risk

    Firefly Integrations is recalling Multiplex HC Relay Cards because damaged relays may cause electrical short circuits, increasing the risk of a fire.

    Product
    EQUIPMENT:ELECTRICAL recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23796·2023-09-28

    Polaris, Gravely, and Bobcat Utility Vehicles Seat Belt Bracket Defect

    About 280 Polaris Ranger, Pro XD, Gravely ATLAS, and Bobcat utility vehicles have defective passenger-side seat belt brackets that may separate from the frame, creating an injury risk. Consumers should stop using the vehicles and contact their dealer for repair.

    Product
    Model Year 2023 Polaris RANGER XP 1000 / XP 1000 Crew and RANGER 1000 / 1000 Crew, Model Year 2024 Polaris Pro XD Full-Size Diesel Crew, Model Year 2024 Gravely ATLAS JSV-3400, and Model Year 2024 Bobcat UV34XL Gas
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23297·2023-09-28

    Solaray Liposomal Multivitamins Recalled for Non-Child-Resistant Packaging

    Nutraceutical Corporation is recalling approximately 85,300 bottles of Solaray Liposomal Multivitamins because the packaging does not meet child-resistant requirements under the Poison Prevention Packaging Act, creating a poisoning risk for young children.

    Product
    Solaray Liposomal Multivitamins
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23295·2023-09-28

    Trek Allant+ 7 Bicycles Recalled Due to Brake Hose Crash Hazard

    Trek is recalling about 7,000 Allant+ 7 bicycles with Tektro brakes because the rear brake hose can kink and break when turning the handlebars, causing loss of control and crashes. Trek has received 58 reports of riders losing control, including two minor injuries.

    Product
    Trek Allant+ 7 bicycles with Tektro brakes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·23298·2023-09-28

    Rust-Oleum Fluorescent Pink Spray Paint Recalled for Impact Injury Hazard

    Rust-Oleum Professional Fluorescent Pink Inverted Marking Spray Paint cans are recalled because the spray valve assembly can detach with force, creating an impact injury hazard. The company has received five reports of detachment with paint splatter and no injuries reported.

    Product
    Rust-Oleum Professional Fluorescent Pink Inverted Marking Spray Paint cans
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·23296·2023-09-28

    Procter & Gamble Recalls Zevo Fly Insect Spray Over Rupture Hazard

    Procter & Gamble is recalling Zevo Fly, Gnat and Fruit Fly Flying Insect Killer3 Value Packs because the aerosol containers can rupture and leak, posing injury and laceration hazards.

    Product
    Zevo Fly, Gnat and Fruit Fly Flying Insect Killer3 Value Packs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1544-2023·2023-09-27

    Dietary Supplement Capsules Recalled for Toxic Yellow Oleander Substitution

    OBC GROUP CORP is recalling NUT DIET MAX dietary supplement capsules due to substitution with toxic Yellow Oleander instead of the labeled ingredient Nuez de la India.

    Product
    NUT DIET MAX, Nuez de la India, Aleurites Moluccanus, 30 Capsules, 500mg Veggie Caps
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2529-2023·2023-09-27

    Ventilator Control Board Spare Parts Recalled Due to Electrical Short-Circuit Risk

    Hamilton Medical is recalling 6 control board spare parts for ventilators due to degrading capacitors that may leak electrolyte and cause electrical short circuits, potentially interrupting ventilation.

    Product
    Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2530-2023·2023-09-27

    Ventilator Spare Parts Recalled for Degrading Capacitor Risk

    Hamilton Medical is recalling ventilator spare parts (ESM Shielding Set) due to potentially degrading capacitors on the control board. These capacitors may leak electrolyte and cause a short circuit, interrupting ventilation.

    Product
    Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2525-2023·2023-09-27

    Portable Intensive Care Ventilator Recalled for Degrading Capacitor Issue

    Hamilton Medical is recalling 164 Hamilton-C1 portable ventilators due to degrading capacitors that may leak electrolyte, causing electrical short circuits that could interrupt ventilation.

    Product
    Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2527-2023·2023-09-27

    Hamilton-T1 Ventilator Recall: Degrading Capacitors May Interrupt Ventilation

    Hamilton Medical recalls 1,216 Hamilton-T1 ventilators due to degrading capacitors on the control board that may leak electrolyte and interrupt ventilation. The recall affects units distributed nationwide in the US and Puerto Rico.

    Product
    Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1174-2023·2023-09-27

    Novartis Withdraws SANDIMMUNE Oral Solution Bottles Due to Crystallization

    Novartis is recalling SANDIMMUNE Oral Solution bottles nationwide because they were found to contain crystals. Patients should contact their pharmacy or prescriber about affected bottles.

    Product
    SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, NDC 0078-0110-22.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2528-2023·2023-09-27

    Intensive Care Ventilators Recalled Due to Capacitor Degradation Risk

    Hamilton Medical is recalling 12 intensive care ventilators (model Hamilton-MR1) due to degrading capacitors that may leak electrolyte, potentially causing ventilation interruption. The recall affects specific serial numbers across the US and Puerto Rico.

    Product
    Hamilton-MR1, REF: 161010, Intensive Care Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1165-2023·2023-09-27

    TRP Natural Eyes Stye Relief sterile eye ointment recalled for lack of sterility assurance

    FDA is recalling TRP Natural Eyes Stye Relief sterile eye ointment due to lack of assurance of sterility. The product was distributed to two accounts in Rhode Island and Colorado.

    Product
    TRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-014-13.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2612-2023·2023-09-27

    TyTek PneumoDart Decompression Device: Updated Instructions for Needle Placement

    Tytek Medical is updating instructions for the TyTek PneumoDart to better identify needle decompression risks and improve placement guidance. Approximately 22,026 units distributed before October 5, 2020 are affected.

    Product
    TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-317
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2620-2023·2023-09-27

    Copan Transfer Pipette Recalled Due to Plastic Defects

    Copan Diagnostics is recalling 2,592 units of 300µL transfer pipettes due to plastic defects that may affect aspiration capability. Affected units were distributed in California.

    Product
    COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1521-2023·2023-09-27

    Honey Roasted Cashews Recalled for Undeclared Soy and Wheat Allergens

    Mount Franklin Foods is recalling three varieties of honey roasted cashews nationwide due to undeclared soy and wheat allergens caused by mislabeling.

    Product
    1. 7 Select Cashews Halves & Pieces Honey Roasted, Net Wt 3 oz, UPC 00052548723804 2. 7 Select Cashews Halves & Pieces Honey Roasted, Net Wt 5 oz, UPC 00052548723811 3. Circle K Honey Roasted Cashews, Net Wt 2 oz, UPC 194283102749
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1162-2023·2023-09-27

    TRP Natural Eyes Pink Eye Relief drops recalled for sterility assurance issues

    TRP Natural Eyes Pink Eye Relief sterile eye drops (Lot FP001, expires 07/24) are being recalled due to lack of assurance of sterility. Consumers with this product should stop using it and consult their healthcare provider.

    Product
    TRP Natural Eyes, Pink Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-094-19.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-1163-2023·2023-09-27

    TRP Natural Eyes Red Eye Relief Recalled for Sterility Failure

    TRP Natural Eyes Red Eye Relief sterile eye drops have been recalled due to lack of assurance of sterility. The recall affects 8,868 units distributed to accounts in Rhode Island and Colorado.

    Product
    TRP Natural Eyes, Red Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-058-15.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2624-2023·2023-09-27

    FDA Recalls ALKP Chemistry Analyzer Slides for Potential Diagnostic Errors

    Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry ALKP Slides worldwide because high alkaline phosphatase samples may cause the analyzer to report falsely low results, potentially missing or delaying liver disease diagnoses.

    Product
    VITROS XT Chemistry Products ALKP Slides
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2623-2023·2023-09-27

    VITROS XT Chemistry TBIL-ALKP Slides recalled for incorrect liver enzyme readings

    Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry TBIL-ALKP Slides because they may report incorrectly low liver enzyme values, potentially leading to missed or delayed liver disease diagnoses. Approximately 52,456 units were distributed worldwide.

    Product
    VITROS XT Chemistry Products TBIL-ALKP Slides
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V653000·2023-09-27

    Peterbilt 567 and 579 Trucks: Fuel Tank Puncture Risk from Loose U-bolts

    PACCAR is recalling 2021-2024 Peterbilt 567 and 579 trucks. U-bolts securing the air tank can contact and wear through the fuel tank over time. A punctured tank can leak fuel, increasing the risk of fire.

    Product
    PETERBILT — PETERBILT 579, 567
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2593-2023·2023-09-27

    APK2 Wheelchair Cushion Battery Pack Defect Can Cause Overheating

    Aquila Corporation recalls 117 APK2 wheelchair cushions with defective battery packs that can overheat. The risk could result in property damage and injury.

    Product
    APK2 Pressure-Sensing Wheelchair Cushions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2589-2023·2023-09-27

    Flexible Intubation Endoscopes Recalled Due to Unconfirmed Sterility

    Karl Storz Endoscopy is recalling 218 units of Five S 5 3x65 flexible intubation endoscopes because sterility assurance cannot be confirmed. The affected devices were distributed worldwide including throughout the United States and Canada.

    Product
    Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2626-2023·2023-09-27

    FLUIDSHIELD 3 N95 Mask Filtration Failure (Lot AM2164811)

    O&M Halyard recalls FLUIDSHIELD 3 N95 masks in orange size small (Lot AM2164811) after one sample failed filtration efficiency testing. The affected masks may not provide adequate respiratory protection.

    Product
    FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2614-2023·2023-09-27

    Abbott Cardiac Defibrillators Recalled for Bluetooth Circuit Component Failure

    Abbott recalled certain ICD and CRT-D devices manufactured before April 2022 due to a Bluetooth malfunction from a crystal component defect in the BLE circuit. The malfunction causes loss of Bluetooth communication, and in some cases, excessive power drain affecting battery longevity.

    Product
    Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA500Q Neutrino VR Implantable Cardioverter Defibrillator: NxT VR ICD REF CDVRA600Q Neutrino DR Implantable Cardioverter Defibrillator:
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2598-2023·2023-09-27

    Stryker ACM Advanced Cement Mixing System Nozzle May Disassemble

    Stryker is recalling the ACM bone cement mixing system because the break-away femoral nozzle may disassemble or break off during surgery, potentially causing loss of device function and components to fall into the surgical site.

    Product
    Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high vacuum through the process Catalog Number: 0306-563-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1171-2023·2023-09-27

    Rasagiline Tablets Recalled Due to Failed Dissolution Specifications

    Aurobindo Pharma USA Inc. is recalling Rasagiline 0.5mg tablets for failing dissolution specifications. Patients using this medication should contact their healthcare provider.

    Product
    Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2608-2023·2023-09-27

    Philips Patient Information Center iX Software Crashes Delay Patient Monitoring

    Philips Patient Information Center iX software versions 4.x may crash due to an Intel Graphics Driver error, causing a blank screen. Users must manually reboot the system, potentially delaying the detection of patient condition changes.

    Product
    Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389; (2) Patient Information Center iX Expand Product Number: 866390; (3) PIC iX Essentials Product Number: 867093; (4) PIC iX Essential
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1161-2023·2023-09-27

    FDA Recalls TRP Natural Eyes Sterile Eye Drops for Lack of Sterility

    The FDA is recalling TRP Natural Eyes Pink Eye Relief eye drops due to lack of assurance of sterility. The product was distributed to accounts in Rhode Island and Colorado.

    Product
    TRP Natural Eyes, Pink Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-013-15.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2599-2023·2023-09-27

    Stryker ACM Cement Mixer Nozzle Risk of Disassembly During Surgery

    Stryker is recalling certain ACM (Advanced Cement Mixing) systems due to risk that the Break-Away Femoral Nozzle may disassemble or break during use, potentially causing loss of function and components entering the surgical site.

    Product
    Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-564-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1155-2023·2023-09-27

    Eye Drops Recalled Due to Lack of Sterility Assurance

    TRP Natural Eyes sterile eye drops are being recalled because the manufacturer cannot assure the product maintains sterility. The recall involves 196,111 units distributed to retailers in Rhode Island and Colorado.

    Product
    TRP Natural Eyes, Dryness Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC:17312-178-15.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-1166-2023·2023-09-27

    TRP Natural Eyes Sterile Eye Ointment Recalled for Lack of Sterility Assurance

    TRP Natural Eyes Sterile Eye Ointment is recalled due to lack of assurance of sterility. The product was distributed to two accounts in Rhode Island and Colorado.

    Product
    TRP Natural Eyes, Twitching Relief, Sterile Eye Ointment, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-099-15.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-1156-2023·2023-09-27

    FDA Recalls TRP Natural Eyes Eye Drops for Sterility Concerns

    FDA is recalling TRP Natural Eyes Dryness Relief eye drops due to lack of assurance of sterility. Approximately 83,898 units were distributed to accounts in Rhode Island and Colorado.

    Product
    TRP Natural Eyes, Dryness Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-096-19.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2616-2023·2023-09-27

    PDS Plus Antibacterial Sutures Recalled for Tensile Strength Defect

    Ethicon is recalling PDS Plus Antibacterial sutures from specific lots that failed internal tensile strength testing. The defective sutures could fail during or after surgery, creating a risk of serious patient harm.

    Product
    PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP507V05, PDP510V05, PDP515V05, PDP662H50, PDP663H50, PDP684H40, PDP9615H40, PDP9625
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2601-2023·2023-09-27

    Stryker ACM System Femoral Nozzle Recall for Potential Disassembly

    Stryker is recalling its ACM Advanced Cement Mixing System due to a defect in the Break-Away Femoral Nozzle that can disassemble or break off during surgical use, risking loss of device function and foreign material in the surgical site.

    Product
    Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-703-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1167-2023·2023-09-27

    octiq Lubricating Eye Drops Recalled Due to Sterility Assurance Defect

    Innovus Pharmaceuticals recalled octiq Lubricating Eye Drops due to lack of assurance of sterility. The affected lot was distributed to accounts in Rhode Island and Colorado.

    Product
    octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Innovus Pharmaceuticals, Inc., Englewood, CO 80112, Made in Jordan, NDC:57483-610-15.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-1157-2023·2023-09-27

    Sterile Eye Drops Recalled for Lack of Sterility Assurance TRP Natural Eyes

    TRP Natural Eyes sterile eye drops have been recalled because their sterility cannot be confirmed. About 8,000 units distributed to medical accounts in Rhode Island and Colorado are affected.

    Product
    TRP Natural Eyes, Eye Lid Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-417-19.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-1160-2023·2023-09-27

    FDA Recalls Eye Ointment Product Due to Sterility Assurance Failure

    The FDA is recalling Major LubriFresh PM eye ointment due to lack of assurance of sterility. Approximately 282,564 units were distributed to accounts in Rhode Island and Colorado.

    Product
    MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, Made in Jordan, NDC: 0904-6488-38.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2603-2023·2023-09-27

    Orthopedic knee implant component lacks final sterilization before shipment

    Encore Medical recalls 20 DJO Surgical Empowr Knee tibia baseplate components that were not sterilized before shipment. If implanted, these components may cause infection requiring treatment or revision surgery.

    Product
    DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Drugs)·D-1175-2023·2023-09-27

    Humanrace Suncare SPF 30 Sunscreen Recalled for Subpotent Protection

    HUMANRACE is recalling Humanrace Suncare Ozone Face Protection Daily Moisturizer SPF 30 because the product does not contain the declared SPF level. Affected consumers should discontinue use immediately.

    Product
    Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF 30, packaged as a 53mL (1.8 fl oz.) bottle, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1164-2023·2023-09-27

    TRP Natural Eyes Red Eye Relief eye drops recalled due to sterility concerns

    TRP Natural Eyes Red Eye Relief PF sterile eye drops are being recalled due to lack of assurance of sterility. Approximately 196,442 units distributed to accounts in Rhode Island and Colorado may be affected.

    Product
    TRP Natural Eyes, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-095-19.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Food)·F-1542-2023·2023-09-27

    Sauce Product Recalled for Undeclared Soy Allergen in Texas

    Somebody's Mother's Island Sauce is recalled due to undeclared soy. Consumers with soy allergies may have an allergic reaction if exposed to this product.

    Product
    Somebody's Mother's Island Sauce, Net Wt 9.5 oz (270g), UPC 5803100115
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1518-2023·2023-09-27

    Circle K Sweet & Spicy Mix recalled for undeclared soy and wheat allergens

    Mount Franklin Foods is recalling Circle K Sweet & Spicy Mix nationwide due to potential undeclared soy and wheat allergens caused by mislabeling. Consumers with soy or wheat allergies should not consume the product.

    Product
    Circle K Sweet & Spicy Mix, Net Wt 7 oz; UPC 194283104613
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1158-2023·2023-09-27

    TRP Natural Eyes Eye Ointment Recalled for Lack of Sterility Assurance

    TRP Natural Eyes sterile eye ointment (NDC 17312-165-13, Lot 180001, EXP 01/25) is being recalled due to lack of assured sterility. The product was distributed to accounts in Rhode Island and Colorado.

    Product
    TRP Natural Eyes, Eye Lid Relief, Sterile Eye ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-165-13.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2615-2023·2023-09-27

    Abbott Implantable Defibrillator Devices Recalled for Bluetooth Malfunction

    Abbott is recalling certain implantable defibrillator devices manufactured before April 2022 due to a Bluetooth malfunction that results in loss of wireless communication and potential excessive battery drain.

    Product
    Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF Cardiac Resynchronization Therapy Defibrillator: NxT HF CRT-D REF CDHFA600Q Entrant HF Cardiac Resynchronization Therapy Defibrillator : HF CRT-D REF CDHFA300Q The primary f
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1517-2023·2023-09-27

    Honey Roasted Sunflower Kernels Recalled for Undeclared Soy and Wheat

    Power Snacks Honey Roasted Sunflower Kernels are being recalled nationwide due to potential undeclared soy and wheat allergens from mislabeling. Approximately 88,084 units are affected.

    Product
    Power Snacks Honey Roasted Sunflower Kernels, Net Wt 1 oz; UPC 076500722025
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2621-2023·2023-09-27

    Smith & Nephew knee implant recall: wrong size in packaging

    Smith & Nephew recalled 8 knee implants from a specific lot after finding packages labeled as SIZE 5N contained SIZE 4N implants instead. Patients who received these implants should contact their surgeon immediately.

    Product
    smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2617-2023·2023-09-27

    PDS II Surgical Sutures Recalled for Tensile Strength Defect

    ETHICON is recalling specific lots of PDS II surgical sutures after internal testing confirmed some units did not meet tensile strength requirements. Approximately 868,363 units were distributed in the United States and globally.

    Product
    PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z416H-50, Z
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2606-2023·2023-09-27

    DJO Surgical Reverse Shoulder System Components Recalled Due to Missing Sterilization

    Reverse shoulder implant components were shipped without final sterilization, potentially leading to infection and possible revision surgery if implanted. Encore Medical is recalling 64 units distributed across the US and internationally.

    Product
    DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder System (RSP) Glenoid, Neutral Head W/ Retaining Screw, 36mm, REF: 508-36-101
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Food)·F-1519-2023·2023-09-27

    Trail Mix Products Recalled for Undeclared Soy and Wheat Allergens

    Mount Franklin Foods LLC is recalling Circle K Get Up Trail Mix and 7 Select Go! Smart Rise & Shine products nationwide because they may contain undeclared soy and/or wheat allergens due to mislabeling.

    Product
    1. Circle K Get Up Trail Mix, Net Wt 2 oz, UPC 194283102893 2. Circle K Get Up Trail Mix, Net Wt 6 oz, UPC 194283104262 3. 7 Select Go! Smart Rise & Shine, Net Wt 2.5 oz, UPC 00052548681500
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1152-2023·2023-09-27

    TRP Natural Eyes Sterile Eye Drops Recalled Due to Sterility Assurance

    TRP Natural Eyes Allergy Eyes Relief Sterile Eye Drops (NDC 17312-032-15, Lot IY001) are recalled due to lack of assurance of sterility. Approximately 8,747 units distributed to accounts in Rhode Island and Colorado.

    Product
    TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-032-15.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2618-2023·2023-09-27

    Omnipod 5 App Software Error Prevented Control on Android Phones

    Omnipod 5 app users on certain Android phones encountered an error that prevented remote control of the insulin delivery system. The issue delayed therapy access but did not interrupt automatic insulin delivery, and was resolved by Insulet restoring cloud security settings.

    Product
    Omnipod 5 Automated Insulin Delivery System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1520-2023·2023-09-27

    Circle K Honey Roasted Peanuts recalled for undeclared soy and wheat allergens

    Mount Franklin Foods is recalling Circle K Honey Roasted Peanuts nationwide due to mislabeling that may result in undeclared soy and/or wheat allergens. Consumers with allergies to these substances should not consume this product.

    Product
    Circle K Honey Roasted Peanuts, Net Wt 2.5 oz, UPC 194283102596
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2605-2023·2023-09-27

    Orthopedic hip stem implant recalled due to sterilization failure

    Encore Medical has recalled a hip stem orthopedic implant that was not sterilized before shipment. Non-sterile implants may cause infection if implanted, requiring treatment and potentially revision surgery.

    Product
    DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2602-2023·2023-09-27

    Stryker ACM System nozzle may disassemble during bone cement mixing

    The break-away femoral nozzle in Stryker's ACM System may disassemble during use, potentially leaving fragments in the surgical site and causing device failure.

    Product
    Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Med. Press- Allows the user to mix bone cement with a constant high vacuum through the process. Catalog Number: 0306-705-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1541-2023·2023-09-27

    White chocolate product recalled for undeclared soy allergen

    Somebody's Mother's White Chocolate (9.5 oz jars, Lot 060723) sold in Texas is being recalled because soy is not declared on the label. The undeclared allergen poses a risk to consumers with soy allergies.

    Product
    Somebody's Mother's White Chocolate, Net Wt 9.5 oz (270g), UPC 5803100102
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1540-2023·2023-09-27

    F-Bombs S'Mores Truffles Recalled for Undeclared Yellow Food Dyes

    Fox Confections LLC recalls F-Bombs S'Mores Truffles due to undeclared FD&C Yellow #5 and Yellow #6 food dyes. The product may trigger reactions in individuals sensitive to these colorants.

    Product
    F-Bombs S'Mores Truffles: 12 ounce plastic packaging, plastic packaging is packed into 4x4x2 cardboard boxes. UPC 850036018155
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-1151-2023·2023-09-27

    FDA Recalls TRP Natural Eyes Eye Drops Due to Sterility Assurance Issue

    The FDA is recalling TRP Natural Eyes Aging Eye Relief eye drops due to lack of assurance of sterility. The affected lot DB001 (expiration 06/24) was distributed to accounts in Rhode Island and Colorado.

    Product
    TRP Natural Eyes, Aging Eye Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-027-15.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2596-2023·2023-09-27

    Stryker ACM Bone Cement Mixer Nozzle May Break During Surgery

    Stryker ACM bone cement mixing system nozzles may break or disassemble during surgical use, causing loss of function and risk of material fragments in the surgical site. Users should stop using affected units.

    Product
    Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a constant high vacuum through the process. Catalog number: 0206-512-000.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2597-2023·2023-09-27

    Stryker bone cement cartridge nozzles may disassemble during surgical use

    Stryker is recalling bone cement cartridges because the breakaway femoral nozzle applicator tip may disassemble or break off during use, potentially causing loss of device function and foreign material in the surgical site.

    Product
    Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0206-530-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1534-2023·2023-09-27

    Chocolate Truffles Recalled for Undeclared Yellow Food Dyes

    Fox Confections is recalling F-Bombs Original Truffles due to undeclared Yellow #5 and Yellow #6 food dyes not listed on the label. Consumers with sensitivities to these dyes may be affected.

    Product
    F-Bombs Original Truffles: 12 ounce plastic packaging, plastic packaging is packed into 4x4x2 cardboard boxes. UPC 850036018001
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1538-2023·2023-09-27

    Red Velvet Truffles Recalled for Undeclared Yellow Food Colorants

    Fox Confections is recalling 138 packages of F-Bombs Red Velvet Truffles sold in Illinois and Ohio retail locations because they contain undeclared FD&C Yellow #5 and Yellow #6 food colorants, which federal regulations require to be clearly labeled.

    Product
    F-Bombs Red Velvet Truffles: 12 ounce plastic packaging, plastic packaging is packed into 4x4x2 cardboard boxes. UPC 850036018049
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2610-2023·2023-09-27

    TyTek Tension Pneumothorax Access Kit Recalled for Inadequate Placement Instructions

    Tytek Medical Inc is recalling the TyTek Tension Pneumothorax Access Kit (Model TM-303) because the instructions do not adequately identify the risks associated with needle decompression or clearly show proper placement site location.

    Product
    TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-303
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2604-2023·2023-09-27

    DJO Surgical Orthopedic Implants Recalled for Sterilization Failure

    DJO Surgical orthopedic implants (lot 878B1171) were shipped without sterilization and may cause infection if implanted, potentially requiring treatment, monitoring, or revision surgery. Contact your healthcare provider to verify your lot number.

    Product
    DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Food)·F-1545-2023·2023-09-27

    Radish Turnip Cake Recalled for Undeclared Wheat Starch and Sulfites

    Southern Taiwan LLC is recalling Radish Turnip Cake distributed in Washington due to undeclared wheat starch and sulfites. The product poses a risk to consumers with wheat or sulfite allergies.

    Product
    Radish Turnip Cake (w/o shrimp): The product comes in a 900g ( 32 ounce), clear plastic package marked with UPC # 425404904110. Ingredients: White Radish, Mushrooms, Fried Dried shallot, White Rice Flour.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1176-2023·2023-09-27

    Sunscreen Recall: Humanrace Ozone Body Protection Cream Lacks Declared SPF

    Humanrace Suncare Ozone Body Protection Cream SPF 30 does not contain the sun protection factor declared on the label. Approximately 2,942 units have been recalled.

    Product
    Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, packaged as a 148mL (5 fl oz.) bottle, PA ++++, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Squalene, Aloe, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-002
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1536-2023·2023-09-27

    F-Bombs Cookies & Cream Truffles recalled for undeclared yellow food dyes

    Fox Confections LLC is recalling F-Bombs Cookies & Cream Truffles distributed in Illinois and Ohio due to undeclared FD&C Yellow #5 and Yellow #6 food colorants that may cause allergic reactions in sensitive individuals.

    Product
    F-Bombs Cookies & Cream Truffles: 12 ounce plastic packaging, plastic packaging is packed into 4x4x2 cardboard boxes. UPC 850036018025
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2594-2023·2023-09-27

    SofTech Wheelchair Cushions Recalled for Defective Battery Overheating Risk

    Aquila Corporation is recalling 134 SofTech Pressure-Sensing Wheelchair Cushions with defective battery packs that can overheat, risking property damage and a possible injury. The affected units have been distributed nationwide in the US and internationally to Canada, Sweden, Romania, Australia, and the UK.

    Product
    SofTech Pressure-Sensing Wheelchair Cushions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1159-2023·2023-09-27

    TRP Natural Eyes Floaters Relief Recalled for Lack of Sterility Assurance

    TRP Natural Eyes Floaters Relief sterile eye drops are being recalled because the manufacturer cannot assure the product meets sterility standards. It was distributed to two direct accounts in Rhode Island and Colorado.

    Product
    TRP Natural Eyes, Floaters Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-098-15.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-1153-2023·2023-09-27

    TRP Natural Eyes sterile eye drops recalled due to lack of sterility assurance

    AMMAN PHARMACEUTICAL INDUSTRIES is recalling TRP Natural Eyes Allergy Relief eye drops due to inability to assure sterility. The recalled lot includes 8,810 units distributed to accounts in Rhode Island and Colorado.

    Product
    TRP Natural Eyes, Allergy Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-097-19.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Food)·F-1537-2023·2023-09-27

    F-Bombs Cookie Dough Truffles recalled for undeclared food dyes

    Fox Confections is recalling F-Bombs Cookie Dough Truffles for containing undeclared FD&C Yellow #5 and Yellow #6 dyes. These undeclared food colorants require immediate consumer notification.

    Product
    F-Bombs Cookie Dough Truffles: 12 ounce plastic packaging, plastic packaging is packed into 4x4x2 cardboard boxes. UPC 850036018032
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2625-2023·2023-09-27

    Philips Tempus Pro Patient Monitor Software Error Impairs Critical Monitoring

    Certain Philips Tempus Pro Patient Monitors may display an error message when laryngoscopes are disconnected, requiring a 60-100 second restart that prevents vital sign monitoring and airway visualization during intubation. This may lead to treatment delays or hypoxia.

    Product
    Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With Tempus Pro Video Laryngoscope, REF 01-2044
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-2600-2023·2023-09-27

    Stryker ACM Cement Mixing System nozzle may break during surgery

    Stryker is recalling ACM Systems due to potential breakage of the femoral nozzle applicator tip during use. This could cause device failure and leave components in the surgical site.

    Product
    Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-573-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1154-2023·2023-09-27

    TRP Natural Eyes sterile eye drops recalled for lack of sterility assurance

    TRP Natural Eyes Blur Relief eye drops are being recalled due to lack of assurance of sterility. The product was distributed to accounts in Rhode Island and Colorado.

    Product
    TRP Natural Eyes, Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-002-11.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2607-2023·2023-09-27

    Orthopedic implant components recalled due to sterilization failure

    Encore Medical is recalling 15 orthopedic implants (DJO Surgical Altivate Reverse) due to sterilization failure. If implanted, unsterilized components may cause infection requiring treatment, monitoring, or revision surgery.

    Product
    DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2595-2023·2023-09-27

    Medline Iris Scissors Recalled Due to Detachable Tip Protector Risk

    Medline is recalling 324,451 sterile iris scissors because the tip protector may detach, exposing a sharp point that could puncture sterile packaging and compromise instrument sterility.

    Product
    MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2611-2023·2023-09-27

    TyTek Tension Pneumothorax Access Kit Instructions Updated for Needle Decompression Safety

    Tytek Medical is updating instructions and visual guidance for its tension pneumothorax kit to clarify needle decompression risks and proper placement. The update affects 4,400 units distributed in the US and international locations.

    Product
    TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-310
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1173-2023·2023-09-27

    Kroger Mint Burst Antiseptic Mouth Rinse recalled for undeclared excipients

    Vi-Jon, LLC is recalling 245,904 bottles of Kroger Mint Burst Antiseptic Mouth Rinse due to incorrect or undeclared excipients. The product was distributed through a single distributor with seven distribution centers.

    Product
    Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%, menthol 0.042%, Methyl salicylate 0.06%, thymol 0.064%), packaged in 16.9 FL OZ (500 mL) bottle, DISTRIBUTED BY THEKROGER CO. CINCINNATI, OHIO 45202, UPC 011110380807
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1535-2023·2023-09-27

    F-Bombs Peanut Butter Truffles recalled for undeclared food dyes

    Fox Confections LLC is recalling F-Bombs Peanut Butter Truffles because they contain undeclared FD&C Yellow #5 and Yellow #6. Consumers with sensitivities to these dyes should not consume the product.

    Product
    F-Bombs Peanut Butter Truffles: 12 ounce plastic packaging, plastic packaging is packed into 4x4x2 cardboard boxes. UPC 850036018018
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2613-2023·2023-09-27

    Prucka 3 Amplifier Power Supply May Fail and Cause Device Inoperability

    GE Medical Systems is recalling Prucka 3 Amplifiers and related field replaceable units used in CardioLab and ComboLab systems. A power supply diode may overheat and fail, causing the amplifier to stop working.

    Product
    Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2590-2023·2023-09-27

    Arrow ErgoPack PICC Catheters Recalled for Incorrect Product Labeling

    Arrow International is recalling 190 units of Arrow ErgoPack One-Lumen PICC catheters (Lot 13F22J0617) because the product code and product name were incorrectly printed on the kit packaging. The units were distributed nationwide.

    Product
    Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1533-2023·2023-09-27

    HEB Easy Melt Salsa Queso Recalled Due to Conflicting Refrigeration Labels

    HEB Easy Melt Salsa Queso is recalled for conflicting refrigeration labels that may cause improper storage. Over 7.2 million pounds were distributed across 32 states.

    Product
    HEB Easy Melt Salsa Queso, with Tomatoes, Jalapeno Peppers & Onions, Net Wt 32 oz (2 lbs) 907g. UPC 0 41220-33063 8. Refrigerate after Opening. Made with Pride and Care for H-E-B, San Antonio, Texas 78204
    Category
    Food
    Distribution
    32 states
  • ModerateFDA (Food)·F-1523-2023·2023-09-27

    Cheese Spread Products Recalled for Inconsistent Refrigeration Requirements

    Multiple cheese spread brands are being recalled due to inconsistent refrigeration instructions on labels. Consumers should verify proper storage and discard products with unclear label instructions.

    Product
    Cheese Spread Pasteurized Process packaged under the following brands and sizes: 1. bowl & Basket, A Shoprite Brand, Net Wt 32 oz (2lb)907g. UPC 0 41190-46935 2. Refrigerate after Opening. Distributed by: Wakeforn Food Corp, 5000 Riverside Drive, Keasbey, NJ 08832 2. Luce
    Category
    Food
    Distribution
    32 states
  • ModerateFDA (Drugs)·D-1168-2023·2023-09-27

    ChloraPrep One-Step Topical Applicators Recalled for Unsupported Shelf-Life Claims

    BD ChloraPrep One-Step topical applicators are recalled because the 36-month shelf life is not supported by stability data; the product may develop fungal contamination beyond 12 months.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide

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