The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

851–875 of 5100

  • SevereFDA (Devices)·Z-3289-2024·2024-10-02

    Boston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Tip Detachment

    Boston Scientific is recalling Agile Esophageal Stent Systems because the delivery catheter tip may detach. The recall affects 17 units distributed worldwide.

    Product
    AGILE ESO OTW PC 23MM X 12.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3090-2024·2024-10-02

    ParaPAC Plus 310 ventilator connector may detach and stop ventilation

    Smiths Medical is recalling paraPAC Plus 310 ventilators because the patient outlet connector may loosen or detach, potentially interrupting ventilation. Approximately 11,244 units worldwide are affected.

    Product
    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3135-2024·2024-10-02

    CARDIOSAVE Rescue IABP software defect poses hemodynamic instability risk

    Datascope CARDIOSAVE Rescue IABP devices have a software defect that risks hemodynamic instability and clinical data transmission failure. A software correction is available.

    Product
    CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3091-2024·2024-10-02

    Smiths Medical Recalls paraPAC 300 Ventilator Kits Due to Connector Issue

    Smiths Medical is recalling 3,182 paraPAC 300 ventilator kits because the patient outlet connector may loosen or detach, impacting active ventilation.

    Product
    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3137-2024·2024-10-02

    CARDIOSAVE RESCUE intra-aortic balloon pump software correction for hemodynamic instability

    Datascope Corp. is issuing a software correction for CARDIOSAVE RESCUE intra-aortic balloon pump devices to address risks of hemodynamic instability and failure to properly transmit clinical data worldwide.

    Product
    CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3292-2024·2024-10-02

    Boston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Tip Detachment

    Boston Scientific is recalling Agile Esophageal Over the Wire Stent Systems because the delivery catheter tip may detach. The recall affects 19 units distributed worldwide.

    Product
    AGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-3084-2024·2024-09-25

    Baxter pharmaceutical compounding inlets recalled for particulate matter contamination

    Baxter is recalling EXACTAMIX compounding device inlets due to particulate matter observed in sterile fluid pathways before use. Approximately 5.8 million units affected worldwide.

    Product
    Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3083-2024·2024-09-25

    Baxter EXACTAMIX pharmaceutical compounding inlets recalled for particulate contamination

    Baxter Healthcare Corporation is recalling EXACTAMIX Inlet components due to particulate matter found in sterile fluid path tubing. Approximately 1.5 million units were distributed worldwide.

    Product
    Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3085-2024·2024-09-25

    Baxter ExactaMix Inlets Recalled for Particulate Contamination Risk

    Baxter Healthcare is recalling ExactaMix pharmaceutical compounding device inlets due to increased reports of particulate matter in the sterile fluid path before use. The recall involves 2,140,046 units with worldwide distribution.

    Product
    Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3082-2024·2024-09-25

    Baxter EXACTAMIX Inlet Compounders Recalled for Particulate Matter Contamination

    Baxter Healthcare is recalling EXACTAMIX Inlet components (H938173 and related codes) due to particulate matter contamination observed in the sterile fluid path before use. Approximately 3.58 million units distributed worldwide are affected.

    Product
    Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3113-2024·2024-09-18

    Medline Recalls Semi-Rigid Suction Liners Due to Suction Loss

    Medline is recalling specific lots of semi-rigid suction liners due to reported adverse events involving potential loss of suction during use.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR BREAST, Pack Number DYNJ908104B; b) PLASTIC MAJOR, Pack Number DYNJ908106B; c) ABDOMINOPLASTY W/LIPO SUCTION, Pack Number DYNJ909946; d) PLASTIC, Pack Number DYNJ909951
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3088-2024·2024-09-18

    Smiths Medical BLUperc tracheostomy tubes recalled for pilot balloon disconnection

    Smiths Medical is recalling BLUperc and BLUselect tracheostomy tube kits worldwide due to a manufacturing defect that could cause the pilot balloon to disconnect from the inflation line, potentially compromising airway management.

    Product
    smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows: 1) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect trach tube, Item Number 101/561/070; 2) BLUperc Percuta
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2972-2024·2024-09-18

    Infusomat Space Infusion Pump Recall Due to Sensor Malfunction

    B Braun is recalling the Infusomat Space Infusion Pump due to a sensor malfunction that can trigger false alarms, risking improper medication delivery.

    Product
    Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1547-2024·2024-09-18

    Olympus Electrosurgical Knives Recalled for Breaking During Use

    Olympus Corporation recalls 4,507 Triangle Tip Electrosurgical Knives (Model KD-640L) due to device fragmentation during use. The issue is linked to reports of serious injury and improper adherence to usage instructions.

    Product
    Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-640L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3026-2024·2024-09-18

    Medline ER Suture Kits Recalled Due to Syringe Quality Issues

    Medline is recalling ER Suture Convenience Kits because the included plastic syringes have leaks, breakage, or other quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: KIT,ER SUTURE #1, Pack Number DYNDS1130A
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3087-2024·2024-09-18

    Smiths Medical Tracheotomy Tube Kits Recalled for Pilot Balloon Disconnection

    Smiths Medical is recalling approximately 12,234 BLUselect, BLUgriggs, and BLUperc tracheotomy tube kits due to a manufacturing defect that may cause the pilot balloon to disconnect from the inflation line.

    Product
    smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows: 1) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect trach tube (drugs, US ONLY), Item Number 101/540/080; 2) BLUgriggs
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1548-2024·2024-09-18

    Olympus Electrosurgical Knives Recalled Due to Breakage During Use

    Olympus Corporation recalled 2,525 electrosurgical knives (KD-645L) nationwide after reports of serious injury from knives breaking off during use. Users must follow Instructions for Use regarding proper electrosurgical unit compatibility and output settings.

    Product
    Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-645L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3108-2024·2024-09-18

    Medline Recalls Semi-Rigid Suction Liners Due to Suction Loss

    Medline Industries is recalling 19 units of semi-rigid suction liners due to reported adverse events involving potential loss of suction during use.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: DENTAL, Pack Number DYNJ909451A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3053-2024·2024-09-18

    Medline Convenience Kits Recalled Due to Syringe Quality Issues

    Medline is recalling C Scope Disposable Kits because they contain plastic syringes affected by a March 2024 FDA Safety Alert regarding leaks and breakage.

    Product
    Medline Convenience kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Code 613034700; 2) C SCOPE DISPOSABLE KIT, Pack Code 613034701; 3) C SCOPE DISPOSABLE KIT, Pack Code 613034702
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2974-2024·2024-09-18

    Pneupac ventilator control knob may shift unintentionally during operation

    Smiths Medical ASD Inc. is recalling 10,240 Pneupac paraPAC plus 310 ventilator kits due to risk of unintended tidal volume knob movement, affecting all serial numbers worldwide.

    Product
    Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3086-2024·2024-09-18

    Smiths Medical Tracheostomy Tubes Recalled Due to Pilot Balloon Disconnection Risk

    Smiths Medical is recalling select BLUSelect tracheostomy tubes due to a manufacturing defect that could cause the pilot balloon to disconnect from the inflation line. No injuries have been reported.

    Product
    smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/060CZ; 2) BLUSELECT 7.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/070CZ; 3) BLUSELECT 7.5, CUFFED, NON-FEN, 10/BX, Item Number 101/800/075C
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2943-2024·2024-09-11

    Trilogy Evo Ventilator Software Update for Identified Safety Issues

    Philips Respironics is issuing a mandatory software update (Version 1.05.10.00) for the Trilogy Evo Universal Ventilator to address safety issues identified in earlier recalls. Affected units should implement the update.

    Product
    Trilogy Evo Universal Ventilator, Model No. DS2000X11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2721-2024·2024-09-11

    Fresenius Kabi IV Administration Sets Recalled for Uncontrolled Medication Flow Risk

    Fresenius Kabi is recalling LVP Primary Administration Sets due to a defect that may cause uncontrolled medication flow and potential overdose. The recall affects 4,500 pieces distributed in Colorado, Idaho, New Jersey, and Utah.

    Product
    LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-2690-2024·2024-09-11

    Vivo 45 LS Ventilator Recall: Potential Formaldehyde Emission Risk

    Breas Medical is recalling the Vivo 45 LS ventilator due to potential elevated formaldehyde emissions into the patient breathing airpath under specific conditions.

    Product
    Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)
    Category
    Medical Device
    Distribution
    Distributed nationwide