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 the agency’s own highest classification or reported deaths or serious injuries, 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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24451–24475 of 40299

  • SevereFDA (Devices)·Z-1125-2018·2018-03-28

    MedComp Two Part Adapter Recall for Potential Connection Failures

    Medical Components, Inc. is recalling 35 MedComp Two Part Adapter kits due to potential connection failures that could cause blood loss or air emboli.

    Product
    TWO PART ADAPTER, REF MCTLA2000, UDI 884908027310 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1139-2018·2018-03-28

    BD Vacutainer Tubes Recalled for Lead Test Inaccuracy

    Becton Dickinson is recalling specific Vacutainer tubes because they may cause underestimation of lead levels in blood samples when used with certain assays.

    Product
    BD Vacutainer¿ EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 50382903664011); 2. 366450 (UDI: 50382903664509); 3. 366643 (UDI: 50382903666435); 4. 367835 (UDI: 50382903678353); 5. 367841 (UDI: 50382903678414); 6. 367844 (UDI: 50382903678445); 7. 367856 (UDI…
    Category
    Medical Device
    Distribution
    47 states
  • SevereFDA (Devices)·Z-1133-2018·2018-03-28

    Boston Scientific Recalls SpyScope DS Biliary Catheters Due to Sleeve Defect

    Boston Scientific is recalling 5,026 units of SpyScope DS Access and Delivery diagnostic biliary catheters because a sleeve may protrude, causing tissue damage or bleeding.

    Product
    SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1075-2018·2018-03-28

    Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope Recalled for Misdirected Energy

    Iridex Corporation is recalling the TruFocus LIO Premiere Laser Indirect Ophthalmoscope because laser energy was not directed as intended, causing focal cataracts and iris burns.

    Product
    Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient s retina. It allows binocular visualization of the peripheral retina…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1141-2018·2018-03-28

    BD Vacutainer Tubes Recalled for Lead Test Inaccuracy

    Becton Dickinson is recalling specific Vacutainer tubes because they may cause underestimation of lead in blood samples when used with certain assays.

    Product
    BD Vacutainer¿ EDTA Pink Top Tube; Catalog Numbers: 1. 367842 (UDI: 50382903678421); 2. 367899 (UDI: 50382903678995); 3. 368049 (UDI: 50382903680493); 4. 368589 (UDI: 50382903685894)
    Category
    Medical Device
    Distribution
    47 states
  • SevereFDA (Devices)·Z-0194-2018·2018-03-28

    Monteris Medical Recalls NeuroBlate Systems Due to MRI Interaction

    Monteris Medical Corp is recalling 52 NeuroBlate systems used for MRI-guided neurosurgery due to an unanticipated interaction with 1.5 Tesla MRI systems.

    Product
    MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1123-2018·2018-03-28

    MedComp Recalls 12F Modified Tesio Catheter Sets Due to Connection Failures

    Medical Components, Inc. is recalling 40 kits of 12F Modified Tesio Catheter Sets because connection failures could cause blood loss or air emboli.

    Product
    12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1142-2018·2018-03-28

    BD Vacutainer Tubes Recalled for Lead Test Inaccuracy

    Becton Dickinson is recalling specific Vacutainer tubes because they may cause underestimation of lead levels in blood samples when used with certain assays.

    Product
    BD Vacutainer¿ Lithium Heparin Green Top Tube; Catalog Numbers: 1. 366664 (UDI: 50382903666640); 2. 367884 (UDI: 50382903678841); 3. 367886 (UDI: 50382903678865); 4. 368040 (UDI: 50382903680400); 5. 366667 (UDI: 50382903666671); 6. 367880 (UDI: 50382903678803)
    Category
    Medical Device
    Distribution
    47 states
  • SevereFDA (Devices)·Z-1119-2018·2018-03-28

    MedComp Repair Kit Recalled for Potential Connection Failures

    Medical Components, Inc. is recalling 5 MedComp Repair Kits due to potential connection failures that could cause blood loss or air emboli.

    Product
    REPAIR KIT, REF ARA101, UDI 884908083637 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1140-2018·2018-03-28

    BD Vacutainer Tubes Recalled for Lead Test Inaccuracy

    Becton Dickinson is recalling specific Vacutainer tubes because they may cause underestimation of lead levels in blood samples when used with certain assays.

    Product
    BD Vacutainer¿ EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551)
    Category
    Medical Device
    Distribution
    47 states
  • SevereFDA (Devices)·Z-1104-2018·2018-03-28

    Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Mid-Shaft Breakage

    Boston Scientific is recalling certain Malecot Nephrostomy Catheters because they are breaking at the mid-shaft bond during use.

    Product
    Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1132-2018·2018-03-28

    NxStage PureFlow B Solution Recalled for Missing Labeling Warnings

    NxStage Medical is recalling 1,243,400 units of PureFlow B Solution because the original labeling failed to warn against mixing dialysate formulations.

    Product
    NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1150-2018·2018-03-28

    Siemens AXIOM Artis angiographic x-ray systems recalled for coolant leaks

    Siemens is recalling 22 AXIOM Artis angiographic x-ray systems because leaking coolant couplings can damage the flat panel detector, potentially requiring treatment cancellation or patient transfer.

    Product
    AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese…
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1135-2018·2018-03-28

    Smiths Medical Medfusion Syringe Pumps Recalled for Syringe Misidentification

    Smiths Medical is recalling Medfusion Syringe Pumps because they may fail to recognize or misidentify loaded medication syringes, preventing proper programming.

    Product
    Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1130-2018·2018-03-28

    Situate Gauze Recalled for Potential Failure to Detect by Console

    Covidien LLC is voluntarily recalling Situate Gauze RF and X-Ray detectable products due to a manufacturing error that may prevent detection by the Situate console.

    Product
    Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate premium cotton are single use cotton disposable that must be used with the Situate delivery system. The disposable have an attached RF Tag, which is an electrically passive inductor like device…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1103-2018·2018-03-28

    Boston Scientific Recalls Re-Entry Malecot Nephrostomy Catheter Sets

    Boston Scientific is recalling specific Re-Entry Malecot Nephrostomy Catheter Sets because they may break at the mid-shaft bond during use.

    Product
    Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography "…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1137-2018·2018-03-28

    ESAOTE MyLab Ultrasound Systems Recalled for Probe Overheating Risk

    ESAOTE is recalling specific MyLab Ultrasound Systems because the probe head may overheat in certain settings.

    Product
    MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1094-2018·2018-03-28

    Centurion Infant IV Securement Kit Recalled by FDA

    Centurion Medical Products Corporation is recalling Infant IV Securement Kits due to a Class II FDA recall. The kits are used to assist with IV placement and securement.

    Product
    INFANT IV SECUREMENT KIT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1134-2018·2018-03-28

    Medfusion Syringe Pumps Recalled for Syringe Misidentification Risk

    Smiths Medical ASD Inc. is recalling Medfusion Syringe Pumps because they may fail to recognize or misidentify loaded medication syringes, potentially preventing proper pump programming.

    Product
    Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1155-2018·2018-03-28

    Bovie Medical Recalls J-Plasma Handpieces Due to Incomplete Cable Seal

    Bovie Medical is recalling 5,416 J-Plasma handpieces worldwide because an incomplete cable seal could allow patient fluid backflow, creating a cross-contamination risk.

    Product
    J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1097-2018·2018-03-28

    Centurion Medical Products Recalls Wound Care Kits

    Centurion Medical Products Corporation is recalling Wound Care Kits due to a Class II medical device recall. The kits are intended to assist practitioners with IV placement and securement.

    Product
    WOUND CARE KIT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1099-2018·2018-03-28

    Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Breakage

    Boston Scientific is recalling 422 units of Malecot Nephrostomy Catheters because they may break at the mid-shaft bond during use.

    Product
    Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980 The Malecot and the Stenting Malecot Catheters are designed for percutaneous drainage within the renal collecting system while maintaining external access. The Stenting Malecot Nephrostomy…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1138-2018·2018-03-28

    ESAOTE MyLab Ultrasound Systems Recalled for Probe Overheating Risk

    ESAOTE is recalling specific MyLab Ultrasound Systems because the probe head may overheat during use in certain settings.

    Product
    MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA523, LA533, SI2C41, SL2325, TRT33
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1144-2018·2018-03-28

    Merit Medical Recalls Custom Dialysis Kits with Incorrect Catheter Configuration

    Merit Medical Systems is recalling 44 custom dialysis kits because they contain 2-cuff catheters incorrectly configured and labeled as 1-cuff products.

    Product
    Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079
    Category
    Medical Device
    Distribution
    0 states