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.

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551–575 of 5027

  • SevereFDA (Devices)·Z-2227-2025·2025-08-20

    DreamStation Auto CPAP units may hold an incorrect device configuration

    DreamStation Auto CPAP non-continuous ventilators are being recalled because the devices may possess a programming error resulting in an incorrect device configuration. 57 units are affected.

    Product
    DreamStation Auto CPAP. Non-Continuous Ventilator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2187-2025·2025-08-13

    BritePro Solo fiber optic laryngoscope handles may not illuminate properly

    BritePro Solo Single-Use Fiber Optic Laryngoscope Handles, REFs 040-310AU and 040-310U, are being recalled because the handles may not illuminate as intended.

    Product
    BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2185-2025·2025-08-13

    BritePro Solo stubby laryngoscope handles may not illuminate as intended

    Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handles are being recalled because the handles may not illuminate as intended.

    Product
    Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2183-2025·2025-08-13

    BritePro Solo laryngoscope handles and blades may not illuminate as intended

    BritePro Solo Single-Use Fiber Optic Handles and Blades in Macintosh and Miller sizes are being recalled because the handles may not illuminate as intended.

    Product
    BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3), 040-335U (Mac 3.5) 040-334U (Mac 4), 040-341U (Miller 1), 040-342U (Miller 2), 040-343U (Miller 3), 040-344U (Miller 4), 040-361U (Phillips 1), 040-36
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2184-2025·2025-08-13

    BritePro Solo mini Miller blade handles may not illuminate as intended

    BritePro Solo Mini with Pro Miller Blade Size 1.5 is being recalled because the laryngoscope handles may not illuminate as intended.

    Product
    BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2186-2025·2025-08-13

    BritePro Solo mini laryngoscope handles may not illuminate as intended

    BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handles are being recalled because the handles may not illuminate as intended.

    Product
    BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2176-2025·2025-08-13

    Microbore extension sets are labeled as having an air eliminating filter

    Microbore Extension Sets with 0.2 Micron Filter are being recalled because the label indicates an air eliminating filter, but the filter fitted is not indicated for air removal. 34,825 US units affected.

    Product
    Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
    Category
    Medical Device
    Distribution
    32 states
  • SevereFDA (Devices)·Z-2129-2025·2025-08-13

    Plum Duo infusion system interface may become unresponsive during programming

    The Plum Duo Infusion System is being recalled because two sequences of programming events and alarm interactions may cause the user interface to become unresponsive. 4,677 units are affected.

    Product
    Plum Duo Infusion System, List Number: 400020401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2179-2025·2025-08-13

    BD Alaris pump modules may perform outside established flow rate ranges

    BD Alaris Pump Module Model 8100 with Guardrails Suite MX software is being recalled because it may perform outside the established ranges for flow rate, bolus accuracy and occlusion alarm timing.

    Product
    BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2180-2025·2025-08-13

    BD Alaris pump infusion sets may perform outside established flow ranges

    BD Alaris Pump Infusion Sets are being recalled because the pump module used with them may perform outside the established ranges for flow rate, bolus accuracy and occlusion alarm timing.

    Product
    BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV; REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 10D 3SS 2CV; REF: 2204-0007, BD Alaris Pum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2182-2025·2025-08-13

    BritePro Solo mini handles and blades may not illuminate as intended

    BritePro Solo Single-Use Fiber Optic Mini Handles and Blades in Macintosh and Miller sizes are being recalled because the handles may not illuminate as intended.

    Product
    BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U (Mac 3 Strong Curve) 040-02-0140U (Mac 4), 040-02-0400U (Miller 00), 040-02-0410U (Miller 1), 040-02-0420U (Miller 2), 040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2160-2025·2025-08-06

    HME TwinStar HEPA Plus filters show a slow rising CO2 curve

    HME TwinStar HEPA Plus bidirectional breathing system filters are being recalled following reports of a slow increase of the CO2 curve when the gas sample is taken from the filter's port. 1,019,782 units affected.

    Product
    HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2158-2025·2025-08-06

    SafeStar 90 Plus breathing filters show a slow rising CO2 curve

    SafeStar 90 Plus bidirectional breathing system filters are being recalled following reports of a slow increase of the CO2 curve when the gas sample is taken from the filter's gas sampling port. 669,838 units affected.

    Product
    SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2159-2025·2025-08-06

    SafeStar 55 Plus breathing filters show a slow rising CO2 curve

    SafeStar 55 Plus bidirectional breathing system filters are being recalled following reports of a slow increase of the CO2 curve when the gas sample is taken from the filter's port. 9,885,139 units affected.

    Product
    SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2164-2025·2025-08-06

    Automated Impella Controllers may not detect a connected Impella pump

    The Automated Impella Controller, used with left heart support blood pumps, is being recalled because of a potential issue with the controller not detecting an Impella pump when it is connected. 11,031 units affected.

    Product
    Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2161-2025·2025-08-06

    SafeStar 60A Plus breathing filters show a slow rising CO2 curve

    SafeStar 60A Plus bidirectional breathing system filters are being recalled following reports of a slow increase of the CO2 curve when the gas sample is taken from the filter's port. 374,700 units affected.

    Product
    SafeStar 60A Plus Filter. Bidirectionally breathing system filter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2167-2025·2025-08-06

    Hamilton coaxial breathing circuits may have a crack in blue tubing

    Coaxial breathing circuit sets for HAMILTON-C1, T1 and MR1 ventilators are being recalled because the blue tubing that delivers fresh gas may be cracked, which can cause rebreathing of exhaled gases. 2,560 units affected.

    Product
    Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2096-2025·2025-07-23

    Baxter SIGMA Spectrum V8 infusion pumps may carry incorrect software version

    Baxter SIGMA Spectrum Infusion Pump V8 units are being recalled because certain pumps may have an incorrect version of software. 28 units are affected.

    Product
    Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Devices)·Z-2095-2025·2025-07-23

    Baxter SIGMA Spectrum V6 infusion pumps may carry incorrect software version

    Baxter SIGMA Spectrum Infusion Pump V6 units are being recalled because certain pumps may have an incorrect version of software. 14 units are affected.

    Product
    Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Devices)·Z-2102-2025·2025-07-23

    i-view video laryngoscopes may be faulty because of depleted batteries

    The i-view video laryngoscope is being recalled because of the potential for faulty devices as a result of depleted batteries. 2,152 pieces are affected.

    Product
    i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-2031-2025·2025-07-16

    Hillrom Q-Link 13 patient lift components may falsely latch and detach

    The Hillrom Q-Link 13 component used with mobile patient lifts is being recalled because it may allow false latching of the quick-release hook. 9,899 units are affected.

    Product
    Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile lift - Product Code 2010004; 2) Viking L Mobile lift - Product Code 2040044; 3) Viking XL Mobile lift - Product Code 2040043; 4) Viking M Mobile lift -
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2081-2025·2025-07-16

    Optisite OPTI18 arterial cannulas may have wire protruding from the body

    Edwards Optisite OPTI18 Arterial Cannulas are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the outside of the cannula body. 13,240 units affected.

    Product
    Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorpo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2082-2025·2025-07-16

    FEM-FLEX II FEMII016A cannulas may have wire protruding from body

    Edwards FEM-FLEX II Femoral Arterial Cannulas, model FEMII016A, are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the cannula body. 6,801 units affected.

    Product
    Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2047-2025·2025-07-16

    Bravo CF capsule delivery devices may have misapplied adhesive causing malfunction

    The Bravo CF capsule delivery device is being recalled because misapplied adhesive may prevent the pH capsule attaching to the oesophagus or detaching from the delivery device. 128,202 units affected.

    Product
    Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2084-2025·2025-07-16

    FEM-FLEX II FEMII018A cannulas may have wire protruding from body

    Edwards FEM-FLEX II Femoral Arterial Cannulas, model FEMII018A, are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the cannula body. 13,240 units affected.

    Product
    Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide