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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3926–3950 of 5111

  • SevereFDA (Devices)·Z-2610-2016·2016-08-31

    Cook Inc. Recalls Beacon Tip Torcon NB Advantage Catheters Due to Tip Fracture

    Cook Inc. is recalling Beacon Tip Torcon NB Advantage Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2615-2016·2016-08-31

    Cook Inc. Recalls FluoroSet Radiographic Tubal Assessment Sets

    Cook Inc. is recalling 1,881 FluoroSet Radiographic Tubal Assessment Sets due to polymer degradation that can cause catheter tip fracture or separation.

    Product
    FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast media into the uterine cavity for radiographic evaluation of the uterine cavity and for injection of appropriate contrast media into the fallopian tubes for eva
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2617-2016·2016-08-31

    Cook Inc. Recalls Kumpe Access Catheters Due to Tip Fracture Risk

    Cook Inc. is recalling 26,076 Kumpe Access Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Kumpe Access Catheter Cathether, Ureteral, General & Plastic Surgery Used in combination with a HiWire, Bentson, or other flexible-tipped wire guide to gain difficult ureteral access beyond a redundant or tortuous ureteral segment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2614-2016·2016-08-31

    Cook Inc. Recalls Slip-Cath Beacon Tip Catheters Due to Tip Fracture

    Cook Inc. is recalling Slip-Cath Beacon Tip Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2620-2016·2016-08-31

    Cook Inc. Recalls Aprima Access Nonvascular Introducer Sets Due to Tip Fracture

    Cook Inc. is recalling Aprima Access Nonvascular Introducer Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to medical complications.

    Product
    Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2651-2016·2016-08-31

    Medtronic Evera ICDs Recalled for Rapid Battery Depletion Risk

    Medtronic is recalling 78 Evera ICDs and Viva CRT-Ds due to a circuit defect causing rapid battery depletion. Seven confirmed failures have resulted in complications like shortness of breath.

    Product
    Medtronic, Evera Implantable Cardioverter Defibrillators: Product Model EVERA XT DDBB1D1, DDBB1D4, DDBB2D1, DDBB2D4, DVBB2D4, DVBB1D1. EVERA S DDBC3D1, DDBC3D4 Product Usage: The Medtronic Evera DR dual chamber and Evera VR single chamber, implantable cardiov
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2609-2016·2016-08-31

    Baxter HomeChoice Peritoneal Dialysis Systems Recalled for Software Defect

    Baxter is recalling HomeChoice and HomeChoice PRO automated peritoneal dialysis systems due to a software defect that may cause serious complications in patients with ascites.

    Product
    1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro Automa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2650-2016·2016-08-31

    Medtronic Recalls 78 Viva Quadripolar Implantable Cardioverter Defibrillators

    Medtronic is recalling 78 Viva Quadripolar Implantable Cardioverter Defibrillators because a circuit defect may cause rapid battery depletion. Seven confirmed failures have been reported.

    Product
    Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1, DTBA1D4 VIVASCRT-D DTBB1D1, DTBB1D4 Product Usage: The Medtronic Viva CRT -D dual chamber, implantable cardioverter defibrillator with cardiac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2623-2016·2016-08-31

    Cook Inc. Recalls White Lumax Guiding Coaxial Catheters Due to Tip Fracture

    Cook Inc. is recalling 3,425 White Lumax Guiding Coaxial Catheters worldwide due to polymer degradation that can cause the catheter tip to fracture or separate.

    Product
    White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for the delivery of angioplasty balloons and other types of interventional devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2661-2016·2016-08-31

    Tecan INFINITE F50 Absorbance Reader Recalled for Battery Overheating Risk

    Tecan US, Inc. is recalling 19 INFINITE F50 absorbance readers because the batteries may overheat, melt, or char.

    Product
    SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain info
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2664-2016·2016-08-31

    Tecan Infinite M1000 Microplate Reader Recalled for Battery Overheating Risk

    Tecan US, Inc. is recalling the Infinite M1000 microplate reader because its batteries may overheat, melt, or char.

    Product
    Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluorescence intensity measurements, the
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2660-2016·2016-08-31

    Tecan Infinite F50 Absorbance Reader Recalled for Battery Overheating Risk

    Tecan US, Inc. is recalling Infinite F50 absorbance readers because the batteries may overheat, melt, or char.

    Product
    Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2666-2016·2016-08-31

    Tecan Hydroflex ELISA Plate Washer Recalled for Battery Overheating Risk

    Tecan US, Inc. is recalling Hydroflex ELISA plate washers because the batteries may overheat, melt, or char.

    Product
    Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be used primarily in in-vitro diagnostic processing of samples from the human body to obtain information on physiological and pathological states. Software and instrument have
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2663-2016·2016-08-31

    Tecan Infinite 200 PRO Microplate Reader Recalled for Battery Overheating

    Tecan US, Inc. is recalling 27 Infinite 200 PRO microplate readers because the batteries may overheat, melt, or char.

    Product
    Infinite 200 PRO The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite 200 PRO has been d
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2621-2016·2016-08-31

    Cook Inc. Recalls Selective Salpingography Catheters Due to Tip Fracture Risk

    Cook Inc. is recalling 7,819 Selective Salpingography Catheters with Beacon Tip due to polymer degradation that can cause the catheter tip to fracture or separate.

    Product
    Selective Salpingography Catheter with Beacon Tip Cannula, Manipulator/ Injector, Uterine Used for injection of contrast medium into the fallopian tube(s) for selective salpingography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2611-2016·2016-08-31

    Cook Inc. Recalls Beacon Tip Royal Flush Plus High-Flow Catheters

    Cook Inc. is recalling 532,395 Beacon Tip Royal Flush Plus High-Flow Catheters worldwide due to polymer degradation that can cause the catheter tip to fracture or separate.

    Product
    Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2619-2016·2016-08-31

    Cook Inc. Recalls Neff DAgostino Percutaneous Access Sets Due to Tip Fracture

    Cook Inc. is recalling 5,020 Neff DAgostino Percutaneous Access Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2612-2016·2016-08-31

    Cook Inc. Recalls Beacon Tip Catheters Due to Tip Fracture Risk

    Cook Inc. is recalling Beacon Tip catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing Catheter Beacon Tip Vessel Sizing Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2533-2016·2016-08-24

    Baxter Recalls VASCU-GUARD Patches Due to Bleeding Reports

    Baxter Healthcare is recalling VASCU-GUARD Peripheral Vascular Patches due to postmarketing reports of intraoperative and postoperative bleeding, including one fatal outcome.

    Product
    Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N, 1 cm x 10 cm, product code VG0110N, and 2 cm x 9 cm, product code VG0209N. VASC U-GUARD is prepared from bovi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2567-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recalled for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Flat L-Hook Electrodes due to a potential sterile barrier breach. The recall covers 119,770 units distributed worldwide.

    Product
    Valleylab Laparoscopic Flat L-Hook Electrode 36CM Item Code: E277436 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2575-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Wire L-Hook Electrodes due to a potential sterile barrier breach. The recall covers 50,055 units distributed worldwide.

    Product
    Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R36ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2386-2016·2016-08-17

    Integra External Fixation System Wire Fixation Bolts Recalled for Breakage

    Integra LifeSciences Corp. is recalling Universal Wire Fixation Bolts because the Slotted Post broke during use at the surgical site.

    Product
    Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixation Bolt - 23 mm Catalogue #12224219
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2387-2016·2016-08-17

    Integra External Fixation System Slotted Post Recall for Breakage During Use

    Integra LifeSciences is recalling 111 units of External Fixation System Slotted Posts because they broke during use at the surgical site.

    Product
    Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2399-2016·2016-08-17

    Invacare Bariatric Bed Recalled for Junction Box Fire Risk

    Invacare is recalling 2,184 Bariatric Beds because a defect in the Junction Box may cause sparks, posing a fire hazard in the presence of flammable materials.

    Product
    Invacare¿ Bariatric Bed w/o mattress & rails, Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2401-2016·2016-08-17

    Invacare Bariatric Bed Foot Section Recalled for Fire Hazard

    Invacare Corporation is recalling 3,050 Bariatric Bed Foot Sections because a junction box defect may cause sparks and fire.

    Product
    Invacare¿ Foot Section for Semi & Full Electric Beds, Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
    Category
    Medical Device
    Distribution
    Distributed nationwide