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

Agency

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

126–150 of 1396

  • SevereFDA (Devices)·Z-1494-2025·2025-04-09

    Draeger ID Circuit Flex 220 breathing circuit hoses subject to cracking

    Draeger's ID Circuit Flex 220 breathing circuit for anesthesia machines may develop cracks in the hose. The recall affects 3,325 units distributed nationwide and internationally.

    Product
    Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult Component: Not applicable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1499-2025·2025-04-09

    Anesthesia Circuit Kit Flex EPA recalled due to breathing hose cracking

    Draeger is recalling the Anesthesia Circuit Kit Flex EPA due to the potential for cracks to form in the breathing circuit hose. Approximately 13,620 units have been distributed domestically and internationally. Users should discontinue use of affected units immediately.

    Product
    Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Catalog Number: MP17103 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intend
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1497-2025·2025-04-09

    Anesthesia Circuit Kit Flex 6 Recalled for Potential Breathing Hose Cracks

    Draeger, Inc. is recalling the Anesthesia Circuit Kit Flex 6 (Model MP02744) due to potential cracks forming in the breathing circuit hose. Approximately 293,660 units were distributed nationwide and internationally.

    Product
    Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Number: MP02744 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1390-2025·2025-04-02

    Shiley Adult Tracheostomy Tubes Recalled Due to Flange Disconnection Risk

    Covidien is recalling 780 Shiley Adult Flexible Tracheostomy Tubes because the flange may disconnect from the outer cannula, potentially causing respiratory failure, aspiration, or death.

    Product
    Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1396-2025·2025-04-02

    CVAC Aspiration System Requires Labeling Update for Pressure Risk

    The CVAC Aspiration System requires a labeling update to add safety instructions for high-viscosity kidney fluid. Continuing fluid inflow without adequate outflow can create dangerous intrarenal pressure imbalances.

    Product
    CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1278-2025·2025-03-26

    Smiths Medical ProPort Implantable Venous Ports Recalled for Separation Defect

    Smiths Medical has recalled 643 ProPort Plastic implantable venous access ports that may separate due to a manufacturing defect. The recall affects units distributed worldwide.

    Product
    smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1287-2025·2025-03-26

    Smiths Medical ProPort Venous Ports Recalled for Potential Housing Separation

    Smiths Medical is recalling ProPort Low Profile Plastic Venous Access Systems because the plastic port housing and reservoir may separate due to a manufacturing defect. Approximately 8,515 units worldwide are affected.

    Product
    smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1282-2025·2025-03-26

    Smiths Medical ProPort Plastic Venous Access System recalled for port separation defect

    Smiths Medical is recalling its ProPort Plastic Venous Access System due to a manufacturing defect that may cause the plastic port housing and reservoir to separate, affecting 1,695 units distributed worldwide.

    Product
    smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1281-2025·2025-03-26

    Smiths Medical ProPort Implantable Port Risk of Component Separation

    Smiths Medical is recalling its ProPort Plastic Implantable Ports due to a manufacturing defect that may cause the port housing and reservoir to separate, potentially compromising device function.

    Product
    smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1279-2025·2025-03-26

    Smiths Medical ProPort Implantable Port Component Separation Due to Manufacturing Defect

    Smiths Medical is recalling ProPort Plastic implantable port systems because the plastic port housing and port reservoir may separate due to a manufacturing defect. The recall affects 2,311 units distributed worldwide.

    Product
    smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1284-2025·2025-03-26

    Smiths Medical ProPort Venous Access System Recalled for Port Separation Risk

    Smiths Medical is recalling ProPort Plastic Venous Access Systems due to a manufacturing defect that can cause the port housing and reservoir to separate. This may result in device failure affecting patients worldwide.

    Product
    smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1286-2025·2025-03-26

    Smiths Medical ProPort Implantable Port May Separate Due to Manufacturing Defect

    Smiths Medical is recalling ProPort Plastic Venous Access Ports because the port housing and reservoir may separate due to a manufacturing defect. Contact your physician if you have an affected device.

    Product
    smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1280-2025·2025-03-26

    Smiths Medical ProPort Implantable Port Housing May Separate Due to Manufacturing Defect

    Smiths Medical is recalling 9,506 ProPort implantable venous access ports due to a manufacturing defect that may cause the port housing and reservoir to separate. No injuries have been reported.

    Product
    smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1285-2025·2025-03-26

    Smiths Medical ProPort Plastic Venous Access System Recalled for Port Housing Separation Risk

    Smiths Medical is recalling certain ProPort Plastic Venous Access System devices due to a manufacturing defect that may cause the port housing and reservoir to separate.

    Product
    smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1283-2025·2025-03-26

    Smiths Medical ProPort Plastic Implantable Ports Recalled for Port Housing Separation

    Smiths Medical is recalling 1961 units of ProPort Plastic Implantable Ports worldwide due to a manufacturing defect that may cause the port housing and reservoir to separate. This Class I recall affects patients dependent on venous access systems.

    Product
    smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1277-2025·2025-03-26

    Smiths Medical ProPort venous access port may separate due to defect

    Smiths Medical is recalling ProPort Plastic Venous Access Ports. The plastic port housing and port reservoir may separate due to a manufacturing defect. The recall affects 3 units distributed worldwide.

    Product
    smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1288-2025·2025-03-26

    Smiths Medical ProPort Implantable Port Plastic Housing May Separate

    The ProPort Low Profile Plastic Venous Access System is being recalled because the port housing and port reservoir may separate due to a manufacturing defect, affecting approximately 2,236 units distributed worldwide.

    Product
    smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1289-2025·2025-03-19

    Portex Endotracheal Tubes may deliver inadequate ventilation due to smaller diameter

    Portex Endotracheal Tubes from Smiths Medical ASD, Inc. may have a smaller diameter than expected, potentially causing inadequate ventilation and patient hypoxia.

    Product
    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1305-2025·2025-03-19

    BD Care Coordination Engine Software May Send Outdated Programming Requests

    BD Care Coordination Engine infusion software may send outdated automated programming requests to care units. Healthcare facilities in affected US states should review their systems.

    Product
    BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
    Category
    Medical Device
    Distribution
    21 states
  • SevereFDA (Devices)·Z-1306-2025·2025-03-19

    Aortic Root Cannula Recall for Loose Male Luer Component

    Medtronic is recalling 316,205 aortic root cannulas due to unexpected loose material in the male luer connector. If not identified before use, this defect could cause stroke; if identified, it may delay surgery.

    Product
    Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 2. MiAR Cannula: A. CANNULA 11012L AR FLOWGUARD LONG 12GA, model no 11012L B. CANNULA 11014L AR FLOWGUARD 14FR LONG, m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1304-2025·2025-03-19

    BD Alaris Systems Manager Infusion Software Affected by Programming Request Issue

    BD Alaris Systems Manager software may transmit outdated automated programming requests to progressive care units. The FDA has classified this as a Class I recall.

    Product
    BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
    Category
    Medical Device
    Distribution
    21 states
  • CriticalFDA (Devices)·Z-1244-2025·2025-03-12

    Rotarex Atherectomy Catheter Recalled for Helix Fracture Risk

    Bard is recalling Rotarex Atherectomy System catheters due to potential helix fracture or breakage that could cause vessel injury and severe bleeding. Updated instructions are being distributed to clarify procedural steps to reduce this risk.

    Product
    Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1257-2025·2025-03-12

    Insulin pump recall: Medtronic Paradigm models malfunction during airplane flight

    Medtronic MiniMed's Paradigm insulin pumps can malfunction during airplane flight due to air pressure changes, potentially causing dangerously high or low blood sugar levels that could be fatal.

    Product
    Paradigm insulin pump, REF: MMT-754
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1263-2025·2025-03-12

    Insulin Pump Recalled for Abnormal Delivery During Flight Pressure Changes

    Medtronic MiniMed 720G insulin pumps may malfunction during airplane travel due to air pressure changes, causing abnormal insulin doses that can lead to severe low or high blood sugar emergencies.

    Product
    MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1245-2025·2025-03-12

    Medtronic Pipeline Vantage Embolization Device Recall for Structural Deformation Risk

    Medtronic is recalling approximately 18,245 unused Pipeline Vantage embolization devices due to incomplete wall apposition and braid deformation that may lead to thrombosis and serious adverse events.

    Product
    Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30,
    Category
    Medical Device
    Distribution
    Distributed nationwide