The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

826–850 of 26417

  • SevereFDA (Devices)·Z-1647-2026·2026-04-08

    Home Ventilator Alarm May Fail to Detect Airway Obstruction Promptly

    The Philips Respironics Trilogy Evo O2 ventilator's obstruction alarm may not trigger promptly, taking up to four breaths to respond. This delay could prevent timely detection of a blocked airway in patients depending on the device for breathing support.

    Product
    Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0478-2026·2026-04-08

    IV Bags Labeled as Magnesium Sulfate Actually Contain Tranexamic Acid

    Amneal Pharmaceuticals is recalling Magnesium Sulfate in Water for Injection IV bags labeled as magnesium sulfate, but actually containing tranexamic acid instead. This product mix-up could cause patients to receive the wrong medication.

    Product
    MAGNESIUM SULFATE — MAGNESIUM SULFATE (MAGNESIUM SULFATE IN WATER FOR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1649-2026·2026-04-08

    Philips Respironics Trilogy Evo Universal Ventilator Obstruction Alarm Delay Recalled

    Philips Respironics Trilogy Evo Universal ventilator software version 1.05.15.00 recalled because the obstruction alarm may fail to trigger within required timeframes, potentially delaying critical responses to airway obstruction.

    Product
    Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1637-2026·2026-04-08

    Blue Ventilator Adapter Module Correction for Oxygen Desaturation Risk

    Baxter Healthcare issued a Class I correction for the Blue Ventilator Adapter Module (Volara system accessory) due to potential oxygen desaturation and lung tissue injury risk in home care settings. Specific instructions for use are being provided.

    Product
    Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1591-2026·2026-04-08

    Impella Controller Purge System Alarm Display May Be Delayed

    The FDA is recalling Automated Impella Controllers because the 'Purge System Blocked' alarm display may be delayed when using first generation Impella 5.5 pumps, potentially delaying notification of blockage.

    Product
    Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Produc
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1589-2026·2026-04-08

    Purge Cassettes May Leak in Impella Pump and Assist Sets

    Abiomed is recalling Purge Cassettes used in Impella pump systems worldwide due to increased risk of purge leaks. The cassettes are included in multiple pump set models distributed across 33,107 units.

    Product
    Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge C
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1646-2026·2026-04-08

    Home Ventilator Obstruction Alarm May Fail to Trigger Promptly

    The Philips Respironics Trilogy Evo home ventilator's obstruction alarm may not trigger within required timeframes, potentially delaying detection of airway blockages. Approximately 113,717 units are affected worldwide.

    Product
    Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1648-2026·2026-04-08

    Philips Respironics Trilogy EV300 Ventilator Recall: Obstruction Alarm Delay

    Philips Respironics Trilogy EV300 ventilators are recalled because the obstruction alarm may not trigger within required timeframes, potentially delaying detection of airway blockages. Over 113,000 units are affected worldwide.

    Product
    Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1756-2026·2026-04-08

    FDA Recalls Burlington Medical Frontal Aprons for Potential Attenuation Degradation

    Burlington Medical recalled 14,323 frontal aprons due to potential degradation of Xenolite 800 attenuation material. The material may lose effectiveness over time, reducing protective capacity.

    Product
    Burlington Medical, Frontal Aprons
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1741-2026·2026-04-08

    Medtronic MiniMed 780G Insulin Pump Dosing Errors With Position Changes

    Medtronic recalls its MiniMed 780G insulin pump due to unintended insulin over- and under-delivery when the pump is elevated or lowered relative to the infusion site. The dosing errors can result in severe hypoglycemia or hyperglycemia.

    Product
    MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1743-2026·2026-04-08

    MiniMed 640G Insulin Pump Incorrect Delivery Based on Pump Position

    Medtronic MiniMed 640G insulin pumps can deliver too much or too little insulin when elevated or lowered relative to the infusion site, potentially causing severe low or high blood sugar emergencies.

    Product
    MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1656-2026·2026-04-08

    RefleXion X1 radiotherapy system software defect causes incorrect dose delivery

    The RefleXion X1 Radiotherapy System software fails to carry forward angular roll corrections into treatment delivery, potentially displacing radiation dose and causing 10-20% underdose. The recall affects 12 systems across 8 U.S. states.

    Product
    RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1683-2026·2026-04-08

    Mentor CPX 4 Breast Tissue Expanders recalled for defective infusion needles

    Mentor Texas is recalling CPX 4 US Breast Tissue Expanders because the infusion needle sets may have dull, blunt, or broken tips that can fail during use.

    Product
    CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH Smooth Medium Height Tissue Expander, 275cc, 350cc, 450cc, 550cc, 650cc, 800cc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1696-2026·2026-04-08

    da Vinci Surgical Scissors Recalled Due to Frayed Grip Cables

    Intuitive Surgical is recalling da Vinci S and Si Monopolar Curved Scissors instruments due to increased reports of broken or frayed grip cables. These reusable surgical instruments transmit motion through cables that could malfunction during endoscopic procedures.

    Product
    Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0639-2026·2026-04-08

    Dumpling Party Tray Products Recalled for Glass Fragments

    JFE Franchising Inc is recalling three dumpling products due to possible glass fragments. Affected products include Dumpling Party Tray (20pcs and 40pcs) Vegetable varieties and Cheetos Flamin Hot Loaded Dumpling Vegetable.

    Product
    " Dumpling Party Tray (20pcs) Vegetable 13 oz 011110661173 " Dumpling Party Tray (40pcs) Vegetable 26 oz 011110661180 " Cheetos Flamin Hot Loaded Dumpling Vegetable 6oz 011110663474
    Category
    Food
    Distribution
    37 states
  • HighFDA (Food)·H-0660-2026·2026-04-08

    Imu-Tek Colostrum-5 Capsules Recalled for Potential Under-Processing

    Imu-Tek Animal Health is recalling Imu-Tek Colostrum-5 120 Capsules (Lot #013, Expiration 092826) because the product is potentially under-processed. The product was distributed across 29 states.

    Product
    Imu-Tek Colostrum-5 120 Capsules; 30% IgG, 2 capsules 2x/day, orally with 8 ounces of water, support a healthy immune system, 3 year shelf life, plastic bottle, inner liner seal and shrink band seal, 500 mg capsule, 7 38654 00026 7, Imu-Tek, Inc. Ft. Collins, CO 80524.
    Category
    Food
    Distribution
    30 states
  • HighFDA (Food)·H-0646-2026·2026-04-08

    Coconut Drink 1 recalled due to undeclared milk allergen

    HEYTEA USA INC is recalling Coconut Drink 1 (1L cartons) because the product contains undeclared milk. Consumers with milk allergies or sensitivities are at risk.

    Product
    Coconut Drink 1; NET VOLUME: 1L; Ingredients: Coconut water, freshly squeezed coconut gravy, white granulated sugar, emulsion stabilizer [sodium caseinate, mono- and diglycerides fatty acid esters, sucrose fatty acid esters]; Storage Condition: Room temperature; Manufactured in:
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0419-2026·2026-04-08

    Prazosin Hydrochloride Capsules Recalled Due to Nitrosamine Impurity

    Appco Pharma LLC is recalling Prazosin Hydrochloride Capsules due to detection of N-nitroso-prazosin impurity above acceptable limits in multiple lots distributed nationwide.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0416-2026·2026-04-08

    Artificial eye drops recalled for lack of sterility assurance

    K.C. Pharmaceuticals recalls Leader Artificial Tears and related generic brands nationwide due to inability to assure product sterility. Approximately 589,848 bottles across multiple brands and retailers are affected.

    Product
    LEADER ARTIFICIAL TEARS 15 ML — LEADER ARTIFICIAL TEARS 15 ML (POLYVINYL ALCOHOL, POVIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0421-2026·2026-04-08

    Prazosin Hydrochloride 5mg Recalled for Nitrosamine Impurity Contamination

    Appco Pharma LLC is recalling Prazosin Hydrochloride Capsules (5mg) due to nitrosamine impurity detected above acceptable limits. The recall affects 28,157 bottles distributed nationwide.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0415-2026·2026-04-08

    Sterile Eye Drops Recalled for Lack of Sterility Assurance

    K.C. Pharmaceuticals is recalling 74,016 bottles of sterile eye drops sold under Rugby and Walgreens brands due to lack of assurance of sterility.

    Product
    STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles; a) Rugby LUBRICATING EYE DROPS, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1219-94; b) Walgreens, Lubricant Eye Drops, DISTRIBUTED BY
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1707-2026·2026-04-08

    Thoracic Biopsy Valve Kits Recalled Due to Rubber Fragment Detachment

    Medline Industries is recalling 14,379 thoracic biopsy valve kits due to rubber fragment detachment in Olympus biopsy valves. Fragments may lodge in the airway and require medical intervention.

    Product
    THORACIC ROBOTS, DYNJ908777B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1701-2026·2026-04-08

    da Vinci Surgical Instruments Recalled for Frayed or Broken Cables

    Intuitive Surgical is recalling 6,152 da Vinci S and Si permanent cautery hook instruments due to complaints of frayed or broken pitch cables that could cause instrument malfunction during surgery.

    Product
    Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Version: NA Product Description: EndoWrist Instruments or da Vinci S/Si Reusable instruments, including blunt and
    Category
    Medical Device
    Distribution
    Distributed nationwide