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

4626–4650 of 5038

  • SevereFDA (Devices)·Z-0812-2014·2014-01-29

    Vital Signs Anesthesia Circuits Recalled Due to Occlusion Risk

    Vital Signs Colorado Inc. is recalling anesthesia and ventilator circuits where a blue port cap may be attached, causing gas flow occlusion.

    Product
    Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer medical gases to a patient during anesthesia. The CPAP Circuit is intended to in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0788-2014·2014-01-29

    Codman TRUFILL n-BCA Liquid Embolic System Recalled for Incorrect Instructions

    Codman & Shurtleff, Inc. is recalling 3,860 units of the TRUFILL n-BCA Liquid Embolic System due to incorrect instructions for use.

    Product
    TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriove
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0723-2014·2014-01-22

    Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Issues

    Boston Scientific is recalling TWISTER PLUS 26mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.

    Product
    TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN):M00561421. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica. Intended to be used in flexible endoscopes as a retrieval
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0743-2014·2014-01-22

    Atrium Medical Recalls Chest Drain Tubing Due to Leak or Disconnect Risk

    Atrium Medical Corporation is recalling 1,944 units of Express Dry Seal ATS Chest Drains because the tubing may leak or disconnect.

    Product
    Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0737-2014·2014-01-22

    Atrium Ocean Water Seal Chest Drain ATS Recall for Tubing Leaks

    Atrium Medical Corporation is recalling 6,684 Ocean Water Seal Chest Drain ATS units because the chest drain tubing may leak or disconnect.

    Product
    Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-300. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0714-2014·2014-01-22

    Draeger Infinity Acute Care System Recall for Alarm Failure

    Draeger Medical Systems is recalling 439 Infinity Acute Care System units because a high-grade SpO2 alarm may fail to activate after a medium-grade alarm is paused.

    Product
    Draeger Infinity Acute Care System Monitoring Solution
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-0726-2014·2014-01-22

    Anspach Carbide Cutting Burrs Recalled Due to Fracture During Use

    The Anspach Effort, Inc. is recalling specific carbide cutting burrs because some fractured during use. The products are intended for cutting and shaping bone.

    Product
    Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball, 10 Flutes - part # QD8-4B-C-10F 5MM Carbide Fluted Ball, 10 Flutes - part #QD8-5B-C-10F 7MM Carbide Fluted Ball, 14 Flutes - part #QD8-7B-C-14F Anspach
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0683-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling NanoClave Needlefree Connectors because a small percentage of devices may leak. The affected units were distributed worldwide.

    Product
    7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave¿ Clear, NThe ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula place
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Devices)·Z-0679-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak. The affected units were distributed worldwide.

    Product
    8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item No. AC102 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Devices)·Z-0650-2014·2014-01-15

    Nova Hospital Blood Glucose Meters Recalled for Battery Swelling and Leakage

    Nova Biomedical is recalling hospital blood glucose meters due to battery swelling and cell leakage. The recall covers approximately 200,000 units distributed nationwide.

    Product
    Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable Lithium Batteries Single: 46626; 4 Pack: 46827; 5 Pack: 50436. For Point-Of-Care usage in the quantitative determin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0694-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    7" (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7103-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administr
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Devices)·Z-0654-2014·2014-01-15

    Anspach Pneumatic Drill System Recalled Due to Hose Rupture Risk

    The Anspach Effort, Inc. is voluntarily removing Pneumatic Drill Systems from the market because the outer hose on the motor hand-piece can rupture without warning if air flow is blocked.

    Product
    ***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc. Intended for cutting and shaping bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0631-2014·2014-01-15

    Anspach BLACKMAX-N Pneumatic Motor Recalled for CJD Exposure Risk

    The Anspach Effort, Inc. is recalling four BLACKMAX-N pneumatic motors and one Autolube III foot control used in a case involving a patient with Creutzfeldt-Jacob Disease.

    Product
    Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0594-2014·2014-01-08

    Asante Comfort Infusion Set Recalled Due to Tubing Disconnects

    Asante Solutions is recalling 834 Comfort Infusion Sets because tubing may disconnect from the connector, causing insulin leakage and reduced delivery.

    Product
    Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5123-4) Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0598-2014·2014-01-08

    Asante Conset Infusion Set Recalled for Tubing Disconnects

    Asante Solutions is recalling Conset Infusion Sets because tubing may disconnect from the connector, causing insulin leakage and under-dosing.

    Product
    Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5226-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0596-2014·2014-01-08

    Asante Comfort Infusion Set Recalled for Tubing Disconnection

    Asante Solutions is recalling 635 Comfort Infusion Sets because the tubing may disconnect from the connector, causing insulin leakage and reduced delivery.

    Product
    Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0597-2014·2014-01-08

    Asante Comfort Infusion Set Recalled for Tubing Disconnects

    Asante Solutions is recalling 352 Comfort Infusion Sets because the tubing may disconnect from the connector, causing insulin leakage and reduced delivery.

    Product
    Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical, Lejre, Denmark
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0603-2014·2014-01-08

    Terumo Cardiovascular Procedure Kits Recalled Due to Uncleared Safety Valve

    Terumo is recalling 24,227 Custom Cardiovascular Procedure Kits because the Overpressure Safety Valve used in the arterial line was not cleared for that specific use.

    Product
    Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0487-2014·2013-12-25

    Nephros SafeSpout Water Filters Recalled for Improper Medical Device Marketing

    Nephros Inc. is recalling SafeSpout water filters because promotional materials made claims that marketed the non-medical products as medical devices.

    Product
    Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla, Italy Filters are packaged in a Tyvek pouch and then placed inside a cardboard box. 15 filters per box The Nephros SafeSpout and SafeShower are intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0540-2014·2013-12-25

    Smiths Medical Recalls Medfusion 4000 Syringe Infusion Pumps for Electrical Shorting

    Smiths Medical is recalling Medfusion 4000 Syringe Infusion Pumps because conductive fluids entering the AC power receptacle can cause electrical shorting, sparking, or flames.

    Product
    Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. These pumps are indicated for use by healthcare professionals in the delivery of IV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0458-2014·2013-12-18

    Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Recalled

    Ethicon is recalling Stratafix Symmetric PDS Plus Knotless Tissue Control Devices due to reported tab failures and fascial dehiscences in lower abdominal incisions.

    Product
    Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0427-2014·2013-12-18

    Cutera truSculpt Infrared System Recalled for Thermal Burn Risk

    Cutera is recalling 451 truSculpt infrared systems because the device caused partial thickness thermal burns to the skin in two patients.

    Product
    Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite. Th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0437-2014·2013-12-11

    Siemens Oncor Linear Accelerators Recalled for Dark Current Radiation Risk

    Siemens is recalling three Oncor Linear Accelerator units due to a potential dark current radiation risk during specific IMRT treatments.

    Product
    SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unflat beam option(Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeuti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0452-2014·2013-12-11

    Synthes Recalls Titanium Trochanteric Fixation Nail Systems Due to Missing Bend

    Synthes USA is recalling 17 units of the Titanium Trochanteric Fixation Nail (TFN) System because two lots are missing a required second bend in the nail.

    Product
    Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide