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 5038

  • 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-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-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-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-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-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-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-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-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
  • 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
  • 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
  • SevereFDA (Devices)·Z-1666-2016·2016-05-18

    Siemens Uric Acid Assays Recalled Due to Drug Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista Uric Acid assays because NAC and Metamizole can cause falsely depressed results.

    Product
    Dimension Vista Assays: Uric Acid (URCA)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1641-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphy
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1639-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards for Labeling Error

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylo
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1632-2016·2016-05-18

    St. Jude Medical Recalls Ellipse ICD Devices for Therapy Failure Risk

    St. Jude Medical is recalling 127 Ellipse ICD devices because they may fail to deliver high-voltage therapy needed to treat life-threatening heart rhythms.

    Product
    Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage: Ellipse ICD devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1634-2016·2016-05-18

    Stryker Recalls CinchLock SS Knotless Anchor Due to Wire Breakage

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

    Product
    CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; 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 for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1637-2016·2016-05-18

    Bradshaw Medical Recalls Axial Torque Limiting Drivers Due to Component Failure

    Bradshaw Medical Inc. is recalling 3,760 Axial Torque Limiting Drivers because a component failure could cause applied torque to exceed the calibrated setting.

    Product
    Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial Torque Limiting Driver is a reusable surgical instrument designed to limit the magnitude of applied (input) torque transferred to an external (output) device or fastener in the clockwise d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1616-2016·2016-05-18

    Atlas Spine Torque Limiting Handle Recalled for Implant Fracture Risk

    Atlas Spine, Inc. is recalling 16 Torque Limiting Handles because they were not appropriately set to mitigate the risk of implant fracture during rotation.

    Product
    Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1648-2016·2016-05-18

    Medtronic Recalls Kangaroo Connect Enteral Feeding Pumps Due to Alarm Failure

    Medtronic is recalling 223 Kangaroo Connect Enteral Feeding Pumps because occlusion alarms may fail to sound, potentially leading to unsafe feeding conditions.

    Product
    Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) Intended to provide enteral nutrition to a patient for hospital and acute care settings.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1535-2016·2016-05-11

    B Braun Recalls Dialog+ Hemodialysis Conductivity Sensors Due to Leakage Risk

    B Braun Medical Inc is recalling 68 Dialog+ Hemodialysis Conductivity Sensors due to a potential leakage hazard. The units were distributed nationwide to various states and territories.

    Product
    Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1531-2016·2016-05-11

    B Braun Recalls Dialog+ Hemodialysis Machines Due to Sensor Leakage Risk

    B Braun Medical Inc is recalling 370 Dialog+ Hemodialysis machines because conductivity sensors may leak. The recall covers units distributed nationwide and in Puerto Rico.

    Product
    Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health ce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1612-2016·2016-05-11

    Philips HeartStart MRx Monitor/Defibrillator Recall for Charging Failure

    Philips is recalling 17 HeartStart MRx Monitor/Defibrillators because a faulty circuit board may prevent the device from charging.

    Product
    HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life sup
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1536-2016·2016-05-11

    B Braun Recalls Dialog+ Hemodialysis Conductivity Sensors Due to Leakage Risk

    B Braun Medical Inc is recalling 147 Dialog+ Hemodialysis Conductivity Sensors due to potential leakage. The sensors are used in dialysis machines for kidney failure patients.

    Product
    Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis cen
    Category
    Medical Device
    Distribution
    Distributed nationwide