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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3976–4000 of 5111

  • SevereFDA (Devices)·Z-1894-2016·2016-06-22

    CareFusion Recalls AVEA Ventilators Due to Fuse Defect

    CareFusion is recalling AVEA Ventilators because a defective fuse on the TCA Board may fail, causing loss of power to the User Interface Module.

    Product
    TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1892-2016·2016-06-22

    CareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect

    CareFusion is recalling AVEA Standard ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1898-2016·2016-06-22

    CareFusion Recalls AVEA Ventilator Upgrade Kits Due to Fuse Defect

    CareFusion is recalling AVEA Ventilator upgrade kits because an incorrect fuse may fail, causing loss of power to the User Interface Module.

    Product
    AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1978-2016·2016-06-22

    Navilyst Recalls Xcela Hybrid PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling specific Xcela Hybrid PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965952430 & H965952470, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the cen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1916-2016·2016-06-15

    Hill-Rom Recalls Liko Universal SlingBars Due to Center Bolt Failure Risk

    Hill-Rom is recalling Liko Universal SlingBars because the center bolt may weaken and break, posing a risk of patient falls and injury.

    Product
    Liko Universal SlingBars Universal SlingBar" 350, Universal SlingBar" 350 QRH, Universal SlingBar" 350 R2R, Universal SlingBar" 450, Universal SlingBar" 450 QRH, Universal SlingBar" 450 R2R, Universal SlingBar" 600 Universal SlingBar" 600 QRH Component of Liko
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1849-2016·2016-06-08

    Curity All Purpose Sponges Recalled Due to Compromised Sterility

    FDA is recalling Curity All Purpose Sponges due to compromised sterility from a barrier breach. The recall affects units distributed in the US and 20 other countries.

    Product
    Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) Item Number: 8047
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1847-2016·2016-06-08

    Curity Gauze Sponges Recalled for Compromised Sterility

    Covidien LLC is recalling Curity Gauze Sponges because a breach of the barrier packaging may have compromised their sterility.

    Product
    Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding, absorb fluid, or protect organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1852-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges because a breach of the barrier packaging may have compromised their sterility.

    Product
    Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number: 6022
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1853-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    FDA is recalling Curity X-Ray Detectable Laparotomy Sponges due to compromised sterility from a barrier breach.

    Product
    Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 36" (20.3 cm x 91.4 cm Item Number: 6056
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1856-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges because a breach of the barrier packaging may have compromised their sterility.

    Product
    Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 4" x 18" (10.2 cm x 45.7 cm) Item Number: 6545
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1857-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges due to compromised sterility caused by a breach of the barrier.

    Product
    Curity" X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 8" x 36" (20.3 cm x 91.4 cm) Item Number: 6556
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1854-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges due to compromised sterility caused by a barrier breach.

    Product
    Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number:6522
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1855-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges because a breach of the barrier packaging may have compromised their sterility.

    Product
    Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm) Item Number:6534
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1848-2016·2016-06-08

    Kerlix X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Kerlix X-Ray Detectable Laparotomy Sponges due to compromised sterility from a barrier breach.

    Product
    Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 16" x 17" (40.6 cm x 43.2 cm) Item Number: 4034
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1851-2016·2016-06-08

    Kerlix X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    FDA is recalling Kerlix X-Ray Detectable Laparotomy Sponges due to compromised sterility from a barrier breach.

    Product
    Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 81.3 cm) Item Number: 4037
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1859-2016·2016-06-08

    Recall of Vistec X-Ray Detectable Sponges Due to Sterility Breach

    Covidien LLC is recalling Vistec X-Ray Detectable Sponges because a breach of the barrier packaging may have compromised sterility.

    Product
    Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7321
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1835-2016·2016-06-08

    Pentax Medical Recalls Video Duodenoscopes Due to CRE Infection Reports

    Pentax Medical is recalling 423 Video Duodenoscopes nationwide after reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility.

    Product
    Video Duodenoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1823-2016·2016-06-01

    Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects

    Biomet, Inc. is recalling specific trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.

    Product
    Various trauma and sports medicine instruments and implants. Screw, fixation, bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1792-2016·2016-06-01

    American Surgical Delicot X Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Delicot X sponges due to packaging defects that compromise sterility. The recall covers 3 boxes distributed worldwide.

    Product
    American Surgical Delicot X 6 mm x 50 mm Ref Number: 63x06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1759-2016·2016-06-01

    American Surgical Cotton Balls Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling 34 boxes of strung cotton balls due to packaging defects that compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Cotton Balls-Strung 1/8" Ref Number: 30-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1614-2016·2016-05-25

    Monteris Medical Recalls NeuroBlate Laser Probes Due to Lens Fracture

    Monteris Medical Corp is recalling 121 NeuroBlate System SideFire Select 2.2 mm Directional Laser Probes because a sapphire lens fractured during a procedure, introducing CO2 into a patient's brain.

    Product
    NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01, SFS122-01, SFS222-01, SFS322-01, SFS422-01, and SFS522-01. NeuroBlate System SideFire Select Directional Laser Probes are part of the NeuroBlate System. The Monteris Me
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1635-2016·2016-05-18

    Stryker Recalls CinchLock Knotless Anchors Due to Internal Wire Breakage

    Stryker is recalling CinchLock Knotless Anchors after 13 reports of internal wire breakage upon deployment.

    Product
    CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used fo
    Category
    Medical Device
    Distribution
    Distributed nationwide