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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626–650 of 5027

  • SevereFDA (Devices)·Z-1817-2025·2025-06-04

    ELEOS Collar Stem Cemented Fluted Implant Size Mislabeling Recall

    Onkos Surgical is recalling 23 units of ELEOS Collar Stem implants (Model HC-13120-03M) because packages labeled as 13mm contained 15mm diameter implants instead, creating a risk of implant mismatch during surgery.

    Product
    ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1746-2025·2025-05-28

    Endopath Echelon Vascular White Reload surgical stapler device lockout

    Ethicon Endo-Surgery is recalling the Endopath Echelon Vascular White Reload surgical stapler due to reports of inadvertent instrument lockout during procedures. The lockout prevents cutting and stapling, potentially requiring conversion to open surgery; one patient death has been reported.

    Product
    Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1757-2025·2025-05-28

    Bard Blakemore Esophageal-Nasogastric Tube Child Difficult Plug Removal

    C.R. Bard is recalling Bard Blakemore Esophageal-Nasogastric Tubes (Child) due to customer complaints that plastic plugs may be difficult or impossible to remove, preventing inflation of the gastric and esophageal balloons.

    Product
    Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-1755-2025·2025-05-28

    Bard Minnesota Four Lumen Esophagogastric Tamponade Tube Recalled

    C.R. Bard Inc is recalling the Bard Minnesota Four Lumen Esophagogastric Tamponade Tube (REF:0092220) because users may be unable to or have difficulty removing plastic plugs needed to inflate the gastric and esophageal balloons.

    Product
    Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (20.3cm) Balloon X-Ray Opaque Rubber
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-1758-2025·2025-05-28

    Bard Blakemore Esophageal-Nasogastric Tube Intermediate Balloon Inflation Difficulty

    C.R. Bard Inc is recalling Bard Blakemore Esophageal-Nasogastric Tubes (Intermediate, REF 0092300) due to reports that plastic plugs may be difficult or impossible to remove, preventing proper inflation of the gastric and/or esophageal balloons.

    Product
    Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-1759-2025·2025-05-28

    Bard Single Intragastric Linton Balloon Tube difficult plastic plug removal

    C.R. Bard Inc is recalling the Bard Single Intragastric Linton Balloon Tube (REF: 0092740) because users may be unable or find it difficult to remove plastic plugs needed to inflate the gastric and esophageal balloons.

    Product
    Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-1767-2025·2025-05-28

    Baxter Novum IQ LVP Infusion System underinfusion risk recall

    Baxter Healthcare is recalling the Novum IQ LVP Infusion System because the device may deliver less medication than intended when using standby mode or after being powered off with the set loaded.

    Product
    Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1756-2025·2025-05-28

    Bard Blakemore Esophageal-Nasogastric Tube difficult balloon inflation

    C.R. Bard is recalling Bard Blakemore Esophageal-Nasogastric Tubes (Adult) because users may find it difficult or impossible to remove the plastic plugs needed to inflate the gastric and esophageal balloons.

    Product
    Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-1760-2025·2025-05-28

    Centerline Biomedical IOPS Guidewire 2 Coating Delamination Risk

    Centerline Biomedical is recalling the IOPS Guidewire 2 (Lot 2404-2005) because the coating may delaminate during use, potentially compromising the guidewire's function during catheter placement procedures.

    Product
    Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-1763-2025·2025-05-21

    LifeShield Infusion Safety Software Recalled for Drug Library Defects

    ICU Medical is recalling LifeShield Drug Library Management software v2.1 and v2.2 due to defects that could allow over-delivery of medication to patients or unauthorized modification of drug parameters.

    Product
    LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1698-2025·2025-05-21

    AirLife Infant Heated Wire Circuit Adapter Disconnection Risk Recall

    Vyaire Medical is recalling the AirLife Infant Heated Wire Circuit (model AH265) because adapters may disconnect during setup or use, potentially interrupting ventilation to newborns. Disconnection can cause hypoxia, hypercapnia, and organ failure.

    Product
    Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit Kit Dual-limb, Dual-heat, high-flow circuit (>4 L/min) Contains AH165 Circuit, AH290 Chamber Compone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1727-2025·2025-05-21

    iGo2 DC Car Adapter Recall: Overheating and Housing Deformation Risk

    Medical Depot Inc. is recalling 89,532 units of the iGo2 DC Car Adapter used with iGo2 Portable Oxygen Concentrator Systems. The DC power supply housing may become excessively hot to the touch and deform, posing a burn and fire hazard.

    Product
    iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1697-2025·2025-05-21

    AirLife Infant Heated Wire Circuit Adapter Disconnection Risk

    Vyaire Medical is recalling the AirLife Infant Heated Wire Circuit (Model AH165) because adapters may disconnect during setup or use, interrupting ventilation to infants and potentially causing severe complications.

    Product
    Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit dual-limb, dual-heat, high-flow circuit (>4 L/min) Component: No. a conduit for respiratory gas bet
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1730-2025·2025-05-21

    MedicaLyte Liquid Bicarbonate Concentrate Recalled for Foreign Matter

    Nipro Renal Solutions USA is recalling MedicaLyte Liquid Bicarbonate Concentrate (models BC+201 and BC+100) due to the potential presence of visible foreign matter in the product.

    Product
    MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1750-2025·2025-05-21

    TufTex Over-the-Wire Embolectomy Catheter incomplete sterile barrier

    LeMaitre Vascular is recalling TufTex Over-the-Wire Embolectomy Catheters due to incomplete seals on some packages that compromise the sterile barrier. Affected units were distributed nationwide and internationally.

    Product
    TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-64, E1651-68, E1651-78, E1651-84, E1651-88, 1651-44J, 1651-48J, 1651-84J, 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1725-2025·2025-05-21

    Welch Allyn Life2000 Ventilation System Recalled for Cybersecurity Vulnerability

    Baxter Healthcare Corporation is recalling the Welch Allyn Life2000 Ventilation system due to a cybersecurity vulnerability discovered through internal testing. The recall affects 4,881 units distributed worldwide.

    Product
    Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5) BT-20-0007; 6) BT200011; 7) BT-20-0011; 8) RMS010118CP.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1726-2025·2025-05-21

    Welch Allyn Life2000 Compressor recalled for cybersecurity vulnerability

    Baxter Healthcare Corporation is recalling Welch Allyn Life2000 Compressor units due to a cybersecurity vulnerability discovered during internal testing.

    Product
    Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1662-2025·2025-05-14

    CADD Solis HSPCA Pump wireless connection alarm interruption recall

    Smiths Medical is recalling CADD Solis HSPCA Pumps with wireless connection modules that may experience intermittent connection alarms, interrupting active infusions and risking serious patient injury or death.

    Product
    CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope: PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, ENGLISH, 1/EA 21-2111-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1667-2025·2025-05-14

    CADD-Solis Ambulatory Infusion Pump False Alarm Malfunction

    Smiths Medical is recalling CADD-Solis and CADD-Solis VIP ambulatory infusion pumps because they may trigger a false upstream occlusion alarm that interrupts therapy, risking serious patient injury or death.

    Product
    CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR CMSA 21-2111-0300-09_CMSA CADD Solis PIB PUMP FOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1668-2025·2025-05-14

    CADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall

    Smiths Medical is recalling CADD-Solis VIP Ambulatory Infusion Pumps due to false Upstream Occlusion Alarms that may interrupt medication infusions, risking serious patient injury or death.

    Product
    CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-2120-0100-95 21-2120-0102-02 21-2120-0102-03 21-2120-0102-06 21-2120-0102-07 21-2120-0102-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1682-2025·2025-05-14

    CADD Solis VIP Ambulatory Infusion Pump Thermal Damage Recall

    Smiths Medical is recalling CADD Solis VIP Ambulatory Infusion Pumps due to potential thermal damage. The recall affects 313,676 units distributed nationwide and worldwide.

    Product
    CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-01; 2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD ENABLED, 1/EA, Model Number: 21-2120-0105-01; 3) PUMP KI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1679-2025·2025-05-14

    Intraocular Lens Recalled Due to Toxic Anterior Segment Syndrome Reports

    Bausch & Lomb has recalled multiple enVista intraocular lens models used in cataract surgery due to reports of toxic anterior segment syndrome (TASS) in the United States. TASS is an inflammatory reaction in the front of the eye following lens implantation.

    Product
    Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Toric IOL, All models starting with ETA;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1717-2025·2025-05-14

    CODMAN Craniotomy Kit Cranial Perforator Disposed Over Weld Defect

    Integra LifeSciences is recalling CODMAN Craniotomy Kits due to inadequate welds that may cause the product to disassemble. The defect affects 1,840 units distributed worldwide.

    Product
    CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1681-2025·2025-05-14

    CADD-Solis Infusion Pump Thermal Damage Risk Recall

    Smiths Medical is recalling CADD-Solis infusion pumps worldwide due to a potential for thermal damage. The affected pumps include multiple models and variants distributed in the US and internationally.

    Product
    CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0402-51; 3) PUMP KIT, CADD-SOLIS, YELLOW, MODEL 21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1680-2025·2025-05-14

    Intraocular Lenses enVista Envy and Envy Toric Recalled

    Bausch & Lomb is recalling enVista Envy and enVista Envy Toric intraocular lenses due to increased reports of toxic anterior segment syndrome (TASS) following implantation.

    Product
    Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
    Category
    Medical Device
    Distribution
    Distributed nationwide