The Recall Desk

Archive

October 2024 recalls

601 recalls were announced in October 2024.

What the numbers show

Critical
4
Severe
86
High
449
Moderate
62

Of the 601 recalls this month scored against our rubric, 1% are Critical, 14% are Severe.

1–100 of 601

  • SevereNHTSA·24V817000·2024-10-31

    Mazda plug-in hybrids can lose drive power in electric mode

    Mazda is recalling certain 2024 CX-90 and 2025 CX-70 plug-in hybrids because improper inverter software may illuminate malfunction lights and cause a loss of drive power in EV mode.

    Product
    MAZDA — MAZDA CX-70, CX-90
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V820000·2024-10-31

    Honda Goldwing crankshaft bolt can break locking the rear wheel

    Honda is recalling certain 2018-2021 GL1800 Goldwing motorcycles because the primary drive gear bolt on the crankshaft may break, causing an engine stall and locking the rear wheel.

    Product
    HONDA — HONDA GL1800
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V813000·2024-10-31

    Outdoors RV Recalls 2025 Travel Trailers Due to Cooktop Flame Inversion Risk

    Outdoors RV is recalling 340 2025 travel trailers because the cooktop flame may invert when the stove and furnace operate simultaneously, increasing the risk of injury or fire.

    Product
    OUTDOORS RV — OUTDOORS RV 260KRS, 20BD, 21MKS, 250RDS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V821000·2024-10-31

    Altec Recalls 2022-2024 AC Series Cranes Due to Outrigger Shoe Defect

    Altec Industries is recalling 2022-2024 AC series cranes because improperly manufactured outrigger shoes may crack and fail, reducing stability and increasing injury risk.

    Product
    ALTEC — ALTEC CRANE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V816000·2024-10-31

    Mazda Recalls 2024 CX-90 Vehicles for Engine Restart Software Issue

    Mazda is recalling 2024 CX-90 vehicles because a software issue may prevent the engine from restarting after the i-stop feature turns it off, increasing crash risk.

    Product
    MAZDA — MAZDA CX-90
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V818000·2024-10-31

    International truck electronic control units can lose ABS and stability control

    International is recalling certain 2021-2025 trucks with Bendix EC80 control units because electrical noise may cause the ECU to misprocess commands or stop working, disabling ABS and stability control.

    Product
    INTERNATIONAL — INTERNATIONAL LT, RH, HX, HV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V815000·2024-10-31

    Mazda CX-90 and CX-70 control module software can cause power loss

    Mazda is recalling certain 2024 CX-90 and 2025 CX-70 vehicles because powertrain and engine control module software may illuminate malfunction lights and cause a loss of drive power.

    Product
    MAZDA — MAZDA CX-70, CX-90
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25024·2024-10-31

    Polaris Ranger XP Kinetic Recreational Off-Road Vehicles Recalled for Fire and Crash Hazards

    Polaris is recalling about 1,400 Model Year 2023-2024 Ranger XP Kinetic recreational off-road vehicles because loose high voltage cables on the motor controller unit can arc or overheat, posing fire and crash hazards.

    Product
    Model Year 2023-2024 Ranger XP Kinetic Recreational Off-Road Vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25025·2024-10-31

    HALO Tumblers with Metal Straws Recalled for Laceration Hazard

    HALO Branded Solutions is recalling about 60,000 reusable tumblers with metal straws sold at Wawa stores due to a laceration hazard. The metal straw can cut the mouth and fingers; four injuries have been reported.

    Product
    Tumblers with a Metal Straw
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V812000·2024-10-31

    Chevrolet Bolt battery can catch fire when charged near full

    GM is recalling certain 2020-2022 Bolt EV and 2022 Bolt EUV vehicles previously repaired under 21V-650, because diagnostic software installation may have failed, so the battery could catch fire at high charge.

    Product
    CHEVROLET — CHEVROLET BOLT EUV, BOLT EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25028·2024-10-31

    Manhattan Comfort Floating Wall Theater Panels Recall Due to Fall Injury Risk

    Manhattan Comfort is recalling about 46,750 floating wall theater entertainment centers because panels can detach and fall when not properly installed with toggle bolts or safety screws. The firm has received 51 reports of panels detaching, including three minor injuries.

    Product
    Manhattan Comfort Floating Wall Theater Entertainment Centers and Panels
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V814000·2024-10-31

    Mazda dash supply unit may disable defroster and other startup functions

    Mazda is recalling certain 2024-2025 CX-90 and 2025 CX-70 vehicles with a Dash Electrical Supply Unit because the defroster, seat belt warning, 360° view monitor and PHEV battery cooling may not work at startup.

    Product
    MAZDA — MAZDA CX-70, CX-90
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25029·2024-10-31

    Vevor Baby Gates Recalled for Child Entrapment Hazard

    Sanven Technology is recalling about 420 Vevor Baby Gates sold online from February to May 2024. The gates violate federal safety regulations because a child's torso can fit through the opening between the gate slat and side wall, creating an entrapment hazard.

    Product
    Vevor Baby Gates
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25027·2024-10-31

    Bauer Battery-Powered Backpack Sprayers Recalled for Fire Hazard

    Harbor Freight Tools recalls about 53,000 Bauer 20V Battery-Powered 4-Gallon Backpack Sprayers because the pump can leak chemicals into the battery compartment, causing the battery to overheat and catch fire. Eight reports of battery overheating, smoking, melting, and fire have been received; no injuries reported.

    Product
    Bauer 20V Battery-Powered 4-Gallon Backpack Sprayers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·25026·2024-10-31

    Humane Charge Case Accessory for Ai Pin Recalled for Lithium Battery Fire Hazard

    Humane Inc. is recalling about 10,500 Charge Case Accessory units for the Ai Pin because the lithium battery can overheat and pose a fire hazard. The company has received one report of a charge case overheating and melting during charging, though no injuries or property damage have been reported.

    Product
    Humane Charge Case Accessory for Ai Pin
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalNHTSA·24V834000·2024-10-30

    Volkswagen Recalls Beetle and Passat Models for Air Bag Inflator Defect

    Volkswagen is recalling specific Beetle and Passat models because the driver's side air bag inflator may explode, posing a risk of serious injury or death.

    Product
    VOLKSWAGEN — VOLKSWAGEN BEETLE CONVERTIBLE, PASSAT, BEETLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0076-2025·2024-10-30

    Aespire 7900 Anesthesia Gas Machine Recalled Over Breathing Circuit Misconnection Risk

    Datex-Ohmeda has recalled 12,036 Aespire 7900 anesthesia gas machines worldwide due to potential risk of patient breathing circuit being mistakenly connected to the Auxiliary Common Gas Outlet port.

    Product
    Aespire 7900. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0083-2025·2024-10-30

    Aisys CS2 Anesthesia Machine Breathing Circuit Misconnection Hazard

    Datex-Ohmeda's Aisys CS2 anesthesia machine may pose a risk if a patient breathing circuit limb is mistakenly connected to the Auxiliary Common Gas Outlet port. Ninety-two units worldwide are affected in this FDA Class I recall.

    Product
    Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0218-2025·2024-10-30

    Baxter TruSystem 7000 Operating Tables Recalled for Electrical Short-Circuits

    Baxter Healthcare is recalling 13 TruSystem 7000 operating tables because their batteries and connectors experienced electrical short-circuits and emitted smoke.

    Product
    Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0055-2025·2024-10-30

    Gluten Free Gochujang Red Chili Paste Recalled for Salmonella

    Choi's Kimchi LLC recalled Gluten Free Gochujang Red Chili Paste due to Salmonella. The recall affects 11 cases distributed in Oregon and Washington.

    Product
    Chois Kimchi Company Gluten Free Gochujang Red Chili Paste, packaged 16oz plastic pouch with spout, keep refrigerated. UP 8 58878 00330 8. Made By Chois Kimchi, LLC Portland, OR 97230.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0078-2025·2024-10-30

    Anesthesia Gas Machine Recall: Breathing Circuit Misconnection Risk

    Datex-Ohmeda is recalling Avance anesthesia gas machines worldwide due to a potential hazard if a patient's breathing circuit is incorrectly connected to the Auxiliary Common Gas Outlet port during setup.

    Product
    Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0074-2025·2024-10-30

    Aespire 7100 Anesthesia Machines Recalled for Breathing Circuit Misconnection

    Datex-Ohmeda is recalling 20,097 Aespire 7100 series anesthesia machines because a patient breathing circuit can be mistakenly connected to the wrong outlet (ACGO port) instead of the intended connection point.

    Product
    Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the adminis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0082-2025·2024-10-30

    Aisys CS2 Anesthesia Machine Recall: Breathing Circuit Misconnection Risk

    Datex-Ohmeda is recalling approximately 15,739 Aisys CS2 anesthesia machines worldwide. A breathing circuit limb may be mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port instead of the intended connection point.

    Product
    Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0046-2025·2024-10-30

    Life2000 Ventilator May Fail to Alarm on Low Gas Pressure

    Baxter Healthcare recalls Life2000 Ventilators due to potential Low Gas Pressure alarm failure. The alarm may not activate if the gas source isn't connected before therapy begins.

    Product
    Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0081-2025·2024-10-30

    Anesthesia Machine Recall Due to Patient Breathing Circuit Misconnection Risk

    Datex-Ohmeda Aisys anesthesia machines may allow patient breathing circuits to be incorrectly connected to the Auxiliary Common Gas Outlet, potentially affecting ventilation during anesthesia. Approximately 4,790 units worldwide are affected.

    Product
    Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0075-2025·2024-10-30

    Aespire 100 anesthesia machine breathing circuit misconnection FDA recall

    Datex-Ohmeda Aespire 100 anesthesia machines are recalled due to potential misconnection of breathing circuit limbs to the Auxiliary Common Gas Outlet port, which could impair anesthesia or ventilation delivery.

    Product
    Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0054-2025·2024-10-30

    Lactaid Lactose Reduced Milk Recalled for Undeclared Almond Allergen

    HP Hood LLC is recalling Lactaid Lactose Reduced milk products because they may contain undeclared almond from almond milk. People with almond allergies face serious health risks.

    Product
    Lactaid Lactose Reduced milk 1. 96 oz Lactaid Whole Milk 2. 96 oz Lactaid 2% Milk 3. 96oz Lactaid 1% Milk 4. 96oz Lactaid Fat Free Milk (1607) 5. 96oz Lactaid 2% Calcium Enriched Milk (15567)
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Devices)·Z-0080-2025·2024-10-30

    Anesthesia gas machines pose risk of breathing circuit misconnection

    Avance CS2 and Avance CS2 Pro anesthesia machines may permit breathing circuit misconnection to the wrong gas outlet. Affected devices have the AGCO option and are distributed worldwide.

    Product
    Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0142-2025·2024-10-30

    Internal Defibrillation Paddles Recalled for Cracks and Separation

    Physio-Control is recalling sterilizable internal defibrillation paddles (LP20 and LP15 models) due to cracking and over-molding separation. The defects may prevent proper device function during critical cardiac emergency treatment.

    Product
    STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Sync
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0220-2025·2024-10-30

    AD-TECH Spencer Probe Depth Electrode recalled for MRI safety label discrepancy

    Ad-Tech is recalling A-style depth electrodes due to incorrect MRI safety labeling. Devices were labeled as MR Conditional when they should be labeled MR Unsafe.

    Product
    AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0224-2025·2024-10-30

    Quantum Perfusion Systems CPB Roller Pumps Recalled for Mechanical Locking Defect

    Spectrum Medical Ltd. is recalling 172 Quantum Perfusion Systems CPB Roller Pumps due to an out-of-tolerance ratchet and pawl defect preventing proper bobbin locking. This defect may affect blood circulation control during cardiac surgery.

    Product
    Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0171-2025·2024-10-30

    Medline Medical Procedure Drape Packs Recalled Due to Non-Sterile Packaging Risk

    Medline is recalling 194 drape packs from breather pouch lot 323080002 that may be non-sterile if the seal is opened. The kits were distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK, REF DYNJ82663B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0157-2025·2024-10-30

    Medline medical procedure kits recalled due to potential non-sterile packaging defect

    Medline brand medical procedure convenience kits packaged in breather pouch lot 323080002 may be non-sterile if the vendor seal is opened or compromised. Affected kits are distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) KIT LINE INSERTION, REF CVI4730A; b) KIT LINE INSERTION, REF CVI4730A; c) LINE INSERTION TRAY, REF DYNJ20803D; d) CENTRAL LINE PACK-LF, REF DYNJ28368; e) CENTRAL LINE PACK-LF, REF DYNJ28368; f) PICC PAC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0154-2025·2024-10-30

    Medline Medical Procedure Convenience Kits Recalled for Potential Sterility Issue

    Medline is recalling 312 medical procedure convenience kits due to potential sterility issues if the breather pouch seal is opened or damaged. The affected kits were distributed in the US, Canada, and Panama.

    Product
    Medline brand, medical procedure convenience kits, labeled as: a) SET UP PACK, REF DYNJ36320A; b) ANGIOGRAM WRO-LF, REF DYNJ41876B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0205-2025·2024-10-30

    Smiths Medical SurgiVet pressure transducer recalled for monitoring failures

    Smiths Medical is recalling SurgiVet Advisor Tech Accessories due to manufacturing defects in the pressure transducer that may cause inaccurate, interrupted, or failed pressure monitoring.

    Product
    smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0198-2025·2024-10-30

    Smiths Medical Recalls TranStar KIDS KIT Blood Sample Kits

    Smiths Medical ASD, Inc. is recalling 900 units of medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT due to a manufacturing defect that may cause inaccurate pressure monitoring.

    Product
    medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0153-2025·2024-10-30

    Medline Procedure Kits Recalled for Non-Sterile Product Risk

    Medline medical procedure kits may contain non-sterile product if the breather pouch seal is opened or compromised. The recall affects 320 units distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK TRAY, REF DYNJRA1854A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0197-2025·2024-10-30

    Smiths Medical Recalls TranStar KIDS KIT Blood Sample Kits

    Smiths Medical ASD, Inc. is recalling 800 units of medex TranStar KIDS KIT closed blood sample kits due to a manufacturing defect that may cause inaccurate pressure monitoring.

    Product
    medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0225-2025·2024-10-30

    Endoscopic Dilation Balloon Mislabeled with Incorrect Size Information

    Olympus EZDilate Wire Guided Balloons with Lot 408987 have mislabeled sizing information. The device label states 11 mm, 12 mm, and 13 mm, but actual balloon sizes are 8.5 mm, 9.5 mm, and 10.5 mm, which may result in prolonged surgery.

    Product
    EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0206-2025·2024-10-30

    Medtronic Percept RC Implantable Neurostimulators Unable to Communicate with Programmer

    Medtronic Percept RC implantable neurostimulators (Model B35300) may fail to communicate with the A610 DBS Clinician Programmer, displaying an 'Invalid Device' message. This prevents clinicians from adjusting therapy.

    Product
    Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0167-2025·2024-10-30

    Medline chest tube insertion tray may contain non-sterile equipment due to breached seal

    Medline is recalling certain chest tube insertion trays due to potential sterility loss if the vendor seal is breached. Non-sterile equipment poses a serious risk during invasive medical procedures.

    Product
    Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0187-2025·2024-10-30

    Smiths Medical Arterial Kit recalled for pressure monitoring defect

    Smiths Medical ASD is recalling medex Arterial Kits due to a manufacturing defect in the TranStar Disposable Pressure Transducer that may cause inaccurate readings or device failure.

    Product
    medex Arterial Kit 1/EA, Product Code REF MX7827
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0193-2025·2024-10-30

    Smiths Medical TranStar Pressure Transducers Recalled for Monitoring Defect

    Smiths Medical recalls medex TranStar DPT pressure transducers due to a manufacturing defect that may cause inaccurate or interrupted pressure monitoring. The defect stems from a leak or chip malfunction.

    Product
    medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0059-2025·2024-10-30

    Happy Moose Juice Strawberry Field recalled for incomplete pasteurization

    Happy Moose Juice Strawberry Field 12 oz bottles are recalled due to incomplete pasteurization affecting 1,017 units distributed across multiple states.

    Product
    Happy Moose Juice Strawberry Field packaged in a plastic 12 fl. oz. bottle. Ingredients: Organic Apple Juice, Organic Orange Juice, Organic Strawberry Puree, Organic Beet Juice, Organic Ginger Juice, Organic Turmeric Juice, Organic Goji Berry Powder, and Organic Cayenne Pepper. U
    Category
    Food
    Distribution
    39 states
  • HighFDA (Devices)·Z-0215-2025·2024-10-30

    Baxter Operating Table TruSystem 7000 Recalled for Battery Short-Circuit Hazard

    Baxter Healthcare recalled 24 units of its TruSystem 7000 operating table worldwide due to battery and connector electrical short-circuits and smoke emission.

    Product
    Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0158-2025·2024-10-30

    Medline Medical Procedure Kits Recalled for Potential Sterility Compromise

    Medline is recalling specific medical procedure convenience kits because a packaging defect could allow non-sterile product to be used if the vendor seal is opened.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF DYNJ17534L; b) BIOPSY TRAY, REF DYNJ43076A; c) LOU LOOP RECORDER PACK, REF DYNJ49404C; d) CT BIOPSY, REF DYNJ52666C; e) BIOPSY KIT, REF DYNJ61130B; f) ASPEN SOFT TISSUE PACK, REF D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0015-2025·2024-10-30

    CADD Medication Cassette Reservoir recalled for weakened weld joint

    Smiths Medical is recalling CADD Medication Cassette Reservoirs due to a production equipment malfunction that weakened weld joints. This could cause medication leakage.

    Product
    CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0058-2025·2024-10-30

    Juice Recall: Incomplete Pasteurization in Happy Moose Tropical Roots

    Happy Moose Juice Tropical Roots is recalled due to incomplete pasteurization of certain bottles. Consumers should not consume products with lot number H240903-E and enjoy-by date 12/02/2024.

    Product
    Happy Moose Juice Tropical Roots packaged in a plastic 12 fl. oz. bottle. Ingredients: Mandarin Orange, Organic Carrot Juice, Organic Pineapple Juice, Lemon Juice, and Organic Turmeric Juice. UPC 860012096503
    Category
    Food
    Distribution
    39 states
  • HighFDA (Drugs)·D-0022-2025·2024-10-30

    FDA recalls epinephrine injection for manufacturing compliance violations

    Fresenius Kabi Compounding recalled epinephrine 0.9% sodium chloride injections due to current good manufacturing practice violations. The recall affecting 753 bags distributed to 125 healthcare accounts was terminated on August 15, 2025.

    Product
    EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0016-2025·2024-10-30

    Phenylephrine Injection Recalled Due to Manufacturing Quality Violations

    Fresenius Kabi Compounding recalled phenylephrine HCl injectable due to cGMP violations. The recall affects 2,756 doses distributed to 125 direct accounts nationwide.

    Product
    Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0020-2025·2024-10-30

    FDA Recalls NORepinephrine Injection Due to Manufacturing Violations

    Fresenius Kabi Compounding is recalling NORepinephrine Bitartrate injection due to manufacturing violations. The affected medication was distributed to 125 accounts nationwide. Healthcare providers using this product should contact their supplier.

    Product
    NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0061-2025·2024-10-30

    Farmers Juice Carrot Digest Recalled Due to Incomplete Pasteurization Risk

    Farmers Juice Carrot Digest is being recalled for incomplete pasteurization, which fails to eliminate harmful bacteria. About 2,521 bottles were distributed across multiple U.S. states.

    Product
    Farmers Juice Carrot Digest packaged in a 12 fl. oz. bottle; Ingredients: Orange, Lemon, Carrot, Ginger, Jicama UPC: 00860006798116
    Category
    Food
    Distribution
    39 states
  • HighFDA (Devices)·Z-0201-2025·2024-10-30

    Blood Sample Pressure Kit Recalled for Monitoring Defects

    Smiths Medical recalls the medex TranStar KIDS KIT blood sample kit due to manufacturing defects in the pressure transducer that may cause inaccurate or interrupted pressure monitoring, or prevent proper device calibration.

    Product
    medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0023-2025·2024-10-30

    Injectable Thiamine Drug Recalled for Manufacturing Compliance Violations

    Fresenius Kabi Compounding recalled 1,008 bags of Thiamine HCl injectable due to current good manufacturing practice violations. The recall was voluntary and nationwide distribution affected 125 accounts.

    Product
    Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0155-2025·2024-10-30

    Medline Medical Procedure Kits Recalled for Potential Non-Sterile Product

    Medline brand medical procedure convenience kits are recalled because their packaging may allow product sterility to be compromised. The affected units were packaged in breather pouch lot 323080002.

    Product
    Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609; b) CARDIAC CATH PACK-LF, REF DYNJ19010I; c) SUPPLEMENTAL NEURO ANGIO PK, REF DYNJ29207; d) ANGIO PACK, REF DYNJ43661C; e) LEFT HEART CATH TEGH-LF, REF DYNJ46746C; f) L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0226-2025·2024-10-30

    Boston Scientific myLUX Patient Application Recalled for Data Transmission Failure

    Boston Scientific is recalling the myLUX Patient Application for Apple mobile devices because it may fail to transmit cardiac monitor data to the LATITUDE Clarity website.

    Product
    Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0159-2025·2024-10-30

    Medline dental pack may contain non-sterile product due to packaging defect

    Medline dental procedure kits may contain non-sterile product if the breather pouch seal is compromised. The recall affects 165 units distributed in the US, Canada, and Panama.

    Product
    Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0156-2025·2024-10-30

    Medline Medical Procedure Kits Recalled for Potential Non-Sterility Risk

    Medline is recalling certain medical procedure kits packaged in breather pouch lot 323080002 because seals may not prevent non-sterile product use. Affected units were distributed in the US, Canada, and Panama.

    Product
    Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PICC INSERTION KIT, REF DYNDC2486A; a) OPEN HEART PACK, REF DYNJ01201L; a) BREAST/CHEST SHEET PACK-LF, REF DYNJ0537343G; a) COTTON ROLL KIT-LF, REF DYNJ3272
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0069-2025·2024-10-30

    Dry Dates Recalled Due to Undeclared Sulfur Dioxide

    BlueStar Direct LLC is recalling 50 lb. bags of dry dates due to undeclared sulfur dioxide. The product was distributed to one location in Illinois.

    Product
    Dry Dates, 50 lb. bag
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0180-2025·2024-10-30

    Medline EYE PACK Medical Kits Recalled for Potential Non-Sterile Packaging

    Medline is recalling 160 units of EYE PACK medical procedure kits due to potential compromises in sterilization. If the vendor seal on the breather pouch is opened or unsealed, the contents may become non-sterile.

    Product
    Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0219-2025·2024-10-30

    AD-TECH Spencer Probe Depth Electrode Recalled for MRI Safety Labeling Error

    Ad-Tech is recalling Spencer Probe Depth Electrodes due to an incorrect MRI safety label. The device was incorrectly labeled as MR Conditional when it is actually MR Unsafe and not cleared for MRI use.

    Product
    AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0175-2025·2024-10-30

    Medline medical procedure kits recalled due to potential non-sterile product risk

    Medline is recalling four types of medical procedure convenience kits that may contain non-sterile products if the pouch seal is opened. Approximately 197 units were distributed nationwide and internationally.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF DYNJ46774B; c) GYN ANCILARY PACK, REF DYNJ84509; d) GYN LITHOTOMY MINOR, REF DYNJ907707
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0137-2025·2024-10-30

    SynchroMed II Infusion Pump Recalled Due to Memory Data Corruption

    Medtronic Neuromodulation is recalling the SynchroMed II Infusion Pump (Product Number 8637-20) due to potential data corruption in the pump's memory that could prevent proper interrogation of the device.

    Product
    SynchroMed II Infusion Pump. Product Number: 8637-20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0192-2025·2024-10-30

    Pressure Monitoring Kit Recalled for Manufacturing Defect and Malfunction

    The medex TranStar 84in Single Monitoring Kit is being recalled due to manufacturing defects in its disposable pressure transducer. The defect may cause inaccurate pressure readings, interruption of monitoring, or inability to zero the device.

    Product
    medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0017-2025·2024-10-30

    Smiths Medical CADD Medication Cassette Recalled for Weld Defect Risk

    Smiths Medical is recalling certain CADD Medication Cassette Reservoirs due to a weakened weld joint between the medication bag and tubing, which could result in medication leakage. No injuries have been reported.

    Product
    ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0136-2025·2024-10-30

    Ultrasound Systems Recalled for Loose Power Connections Causing Thermal Hazard

    B-K Medical A/S is recalling 1,648 ultrasound systems due to loose power connections that can cause excessive heat and potential thermal events.

    Product
    bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0060-2025·2024-10-30

    Farmers Juice Focus Greens Recalled Due to Incomplete Pasteurization

    Youngstown Grape Distributors is recalling Farmers Juice Focus Greens due to incomplete pasteurization, which may allow bacterial growth. Approximately 7,909 bottles with lot H240906-G are affected.

    Product
    Farmers Juice Focus Greens packaged in a 12 fl. oz. bottle; Ingredients: Cucumber, Celery, Fennel, Romaine Lettuce, Lemon, Mint, Green Cabbage, Ginger, Turmeric, Basil, & Matcha. UPC: 00860006798048
    Category
    Food
    Distribution
    39 states
  • HighFDA (Food)·F-0057-2025·2024-10-30

    Sour Charlie bread recalled for undeclared wheat allergen

    Salt City Baking Company recalls Sour Charlie bread due to missing ingredient labeling. Product contains wheat flour but was distributed without an Ingredients Statement, posing a risk to wheat-allergic consumers.

    Product
    Sour Charlie bread, #2092, bag of 6 rolls (net wt. 7oz), 48 mini loaves per case. UPC code 0076011611894. Product was packaged bulk in a clear plastic bag inside a cardboard box and was not sold to consumers. Product was not labeled with a best by/exp date but recalling firm s
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0170-2025·2024-10-30

    Medline Tubal Ligation Kits Recalled for Potential Sterility Compromise

    Medline is recalling certain tubal ligation procedure kits due to potential loss of sterility if the pouch seal becomes compromised during storage or handling.

    Product
    Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0200-2025·2024-10-30

    Medex TranStar Kids blood sample kit recalled for pressure monitoring failures

    Smiths Medical is recalling approximately 3,280 medex TranStar KIDS KIT blood sample devices due to a manufacturing defect causing pressure monitoring failures.

    Product
    medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0165-2025·2024-10-30

    Medline Medical Procedure Kits Recalled Due to Potential Non-Sterility Risk

    Medline is recalling approximately 1,048 medical procedure convenience kits that may become non-sterile if their protective pouch seal is compromised. The affected kits were packaged with breather pouches from lot 323080002.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, REF DYNJ43457; c) BREAST PK TEGH-LF, REF DYNJ46717A; d) BREAST PK TEGH-LF, REF DYNJ46717A; e) BREAST BIOPSY-LF, REF DYNJ53205B; f) BREAST BIOPSY-LF, REF D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0210-2025·2024-10-30

    Baxter TruSystem 7000 Operating Tables: Battery Short-Circuits, Smoke Risk

    Baxter Healthcare is recalling 6,045 TruSystem 7000 U operating tables worldwide due to battery and connector failures that can cause electrical short-circuits and emit smoke.

    Product
    Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF 1604788; c) REF 1723633
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0063-2025·2024-10-30

    SureLife Foods Paleo Bars recalled for undeclared gluten

    SureLife Foods Paleo Bars labeled as gluten-free contain gluten above 20 ppm according to consumer advocacy group testing. Approximately 48,384 units were distributed in California and Oregon.

    Product
    Principal Display: SureLife Foods PALEO BARS, Net Wt. 14 oz. (392 g.)- 14 ct. individually wrapped bars (28 g. each) Certified Gluten Free, Certified Paleo Loaed with: Almonds, Honey, Shredded Coconut, Pumpkin Seeds, Brazil Nuts, Chia Seeds & More! Back Display: Ingredients:
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0164-2025·2024-10-30

    Medline catheter procedure kits recalled for potential sterility compromise

    Medline is recalling 8,830 medical procedure convenience kits with potential breather pouch seal failure that could allow non-sterile product use.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b) TRAY FOL LATX UM COUD 16FR MF, REF DYND150216CS; c) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S; d) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0176-2025·2024-10-30

    Medline Medical Procedure Kits Recalled for Potential Non-Sterility Risk

    Medline is recalling 88 convenience kits used in gynecological medical procedures due to potential non-sterility if the breather pouch seal is compromised. The affected lots are distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL HYSTERECTOMY TEGH-LF, REF DYNJ46730; b) HYSTEROSCOPY PACK, REF DYNJ49302A; c) PERI GYN PACK, REF DYNJ57526A; d) HYSTEROSCOPY TRAY ACS, REF DYNJ68750
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0194-2025·2024-10-30

    Smiths Medical TranStar Pressure Transducers Recalled Due to Manufacturing Defect

    Smiths Medical is recalling 1,000 units of medex TranStar DPT pressure transducers that may monitor inaccurately or interrupt monitoring due to a manufacturing defect. Users may be unable to zero the device.

    Product
    medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0146-2025·2024-10-30

    Smiths Medical Tracheostomy Speaking Valve Recall for Packaging Integrity Issue

    Smiths Medical is recalling 27,971 Portex ORATOR speaking valves for tracheostomy tubes due to uncertainty in sterile packaging seal integrity. The affected units may not maintain sterile status, potentially exposing users to contamination.

    Product
    smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0135-2025·2024-10-30

    Olympus Soltive Pro Laser Systems Recalled for Incorrect Bladder Stone Translation

    Olympus is recalling Soltive Pro SuperPulsed Laser Systems because the term 'Bladder Stone' was incorrectly translated as 'Kidney Stone' in Spanish and Portuguese, posing a risk of unintended energy delivery.

    Product
    Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue Model/Catalog Number: TFL-SLS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0202-2025·2024-10-30

    medex TranStar Pressure Transducer Stopcock Recalled for Manufacturing Defect

    Smiths Medical is recalling the medex TranStar Stopcock due to a manufacturing defect that can cause inaccurate pressure monitoring, interrupted pressure monitoring, or inability to zero the device.

    Product
    medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0011-2025·2024-10-30

    CADD Medication Cassette Reservoir Recalled for Weld Defect Risk

    Smiths Medical is recalling 385,558 units of CADD Medication Cassette Reservoirs due to a weakened weld joint that could cause medication leakage. Affected units were distributed worldwide; users should discontinue use of recalled lot numbers immediately.

    Product
    CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0014-2025·2024-10-30

    CADD Medication Cassette Reservoir weld defect poses leakage risk

    Smiths Medical ASD is recalling 41,964 CADD Medication Cassette Reservoirs (50mL) due to weakened weld joints that could cause medication leakage. The defect results from a production equipment malfunction.

    Product
    CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0017-2025·2024-10-30

    Phenylephrine HCl Injectable Drug Recalled for Manufacturing Practice Violations

    Fresenius Kabi is recalling 1,378 bags of phenylephrine HCl injection due to manufacturing violations. The recall affects 125 healthcare facilities nationwide.

    Product
    Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0196-2025·2024-10-30

    medex TranStar Neonatal Monitoring Kit Recalled Due to Pressure Transducer Defect

    Smiths Medical is recalling the medex TranStar Neonatal Monitoring Kit due to manufacturing defects in the pressure transducer that may cause inaccurate readings or monitoring failures.

    Product
    medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0174-2025·2024-10-30

    Medline convenience kits recalled for potential use of non-sterile product

    Medline brand obstetric convenience kits packaged in breather pouch lot 323080002 may become non-sterile if the vendor seal is opened or unsealed.

    Product
    Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF DYNJ0213264O; 2) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 3) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 4) VAGINAL DELIVERY, REF DYNJ04865M; 5) VAGINAL DELIVERY PACK-LF, RE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0185-2025·2024-10-30

    Medex TranStar pressure monitoring kit recalled for manufacturing defect

    Smiths Medical ASD is recalling the medex TRANSTAR MONITORING KIT due to a manufacturing defect that may cause inaccurate pressure readings, monitoring interruption, or inability to zero the device. Affected units have Lot Number 4270117.

    Product
    medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0010-2025·2024-10-30

    CADD Medication Cassette Reservoirs recalled for potential medication leakage

    Smiths Medical is recalling CADD Medication Cassette Reservoirs because weakened weld joints may cause medication leakage. The defect affects 125,928 units distributed worldwide.

    Product
    CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0149-2025·2024-10-30

    Medline Centurion EP LAB INSTRUMENT KIT Recalled for Potential Sterility Compromise

    Medline Industries is recalling 90 units of Centurion EP LAB INSTRUMENT KIT convenience kits from lot 23LBK889. The kits may contain non-sterile product if the breather pouch vendor seal is opened or compromised.

    Product
    Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0211-2025·2024-10-30

    Baxter Operating Table TruSystem 7000 Recalled for Battery Short-Circuit Risk

    Baxter Healthcare Corporation is recalling the TruSystem 7000 Operating Table due to battery and connector short-circuits that can emit smoke, creating fire and electrical hazards during surgery.

    Product
    Baxter Operating Table TruSystem 7000, Product code REF 1841046
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0084-2025·2024-10-30

    Datex-Ohmeda Auxiliary Common Gas Outlet Conversion Kits Recalled

    Datex-Ohmeda is recalling 649 Auxiliary Common Gas Outlet (ACGO) conversion kits due to a potential issue if a patient breathing circuit limb is mistakenly connected to the ACGO port.

    Product
    Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, however are included due to being purchased with or later used to convert to ACGO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0079-2025·2024-10-30

    Amingo Anesthesia System: Risk of Breathing Circuit Misconnection to Auxiliary Outlet

    Datex-Ohmeda Amingo anesthesia systems may allow a patient breathing circuit to be mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) instead of the proper outlet. The potential misconnection affects all 77 units worldwide.

    Product
    Amingo. OUS only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0160-2025·2024-10-30

    Medline Medical Procedure Kits Recalled Due to Non-Sterile Packaging Risk

    Medline Industries is recalling 2,740 surgical convenience kits with breather pouches that may result in non-sterile product if the vendor seal is opened. The recall affects units distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF CDS982091I; 2) TONSIL CDS, REF CDS984492B; 3) RV T&A PACK-LF, REF DYNJ0798129I; 4) DIRECT MICRO LARYNG PK-LF, REF DYNJ30591I; 5) APU LINE PACK, REF DYNJ37171A; 6) T&A PACK-LF, REF DYNJ40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0012-2025·2024-10-30

    CADD Medication Cassette Reservoir recalled for potential medication leakage

    Smiths Medical is recalling CADD Medication Cassette Reservoirs (100mL) due to a production equipment malfunction that may weaken the weld joint between the medication bag and tubing, potentially causing medication leakage. The recall affects 26,160 units distributed worldwide.

    Product
    CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0068-2025·2024-10-30

    Collagen Joint Support with Black Currant Recalled for Undeclared Fish Allergen

    Quantum Fulfillment and Support, LLC recalls Collagen Joint Support with Black Currant (lot Q241851) distributed direct-to-consumer in the USA due to undeclared fish allergen. Consumers with fish allergies risk allergic reactions if they consume this product.

    Product
    Collagen Joint Support with Black Currant LOT#: Q241851; 14 Stick Pack 3.92 oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0221-2025·2024-10-30

    AD-TECH Spencer Probe Depth Electrodes recalled for MRI safety labeling error

    Ad-Tech Medical Instrument Corporation is recalling 14 units of its AD-TECH Spencer Probe Depth Electrodes due to an incorrect MRI safety label. The devices were labeled as MRI Conditional when they are actually MRI Unsafe, creating a risk of misuse.

    Product
    AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0077-2025·2024-10-30

    Datex-Ohmeda Aespire View Anesthesia Machines Recalled for Connection Error Risk

    Datex-Ohmeda is recalling 10,338 Aespire View anesthesia machines due to a potential issue where a patient breathing circuit limb may be mistakenly connected to the Auxiliary Common Gas Outlet port.

    Product
    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0188-2025·2024-10-30

    Smiths Medical Recalls TranStar Disposable Pressure Transducers Due to Defects

    Smiths Medical ASD, Inc. is recalling 1,100 units of medex TranStar Disposable Transducers due to manufacturing defects that may cause inaccurate pressure monitoring.

    Product
    medex TranStar Disposable Transducer 1/EA, Product Code REF MX950
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0062-2025·2024-10-30

    Farmers Juice Watermelon Hydration recalled due to incomplete pasteurization

    Youngstown Grape Distributors, Inc. is recalling 1,953 bottles of Farmers Juice Watermelon Hydration due to incomplete pasteurization, which may allow pathogenic bacteria to survive in the product.

    Product
    Farmers Juice Watermelon Hydration packaged in a 12 fl. oz. bottle; Ingredients: Watermelon, Lime, Mint
    Category
    Food
    Distribution
    39 states
  • HighFDA (Drugs)·D-0024-2025·2024-10-30

    Dietary supplement tablets recalled for undeclared diclofenac and acetaminophen

    AK Forte Ortiga y Omega 3 tablets are recalled nationwide for containing undeclared diclofenac and acetaminophen without FDA approval. Consumers should stop using this product immediately.

    Product
    AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0216-2025·2024-10-30

    Baxter Operating Table TruSystem 7000 recalled for battery electrical hazards

    Baxter Healthcare is recalling the TruSystem 7000 (dV) V operating table worldwide due to batteries and connectors that may experience electrical short-circuits and emit smoke.

    Product
    Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083
    Category
    Medical Device
    Distribution
    0 states

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