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.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

30251–30275 of 40325

  • ModerateFDA (Devices)·Z-1570-2016·2016-05-04

    BD Trucount Absolute Counting Tubes Recalled for Lot Mixing

    Becton, Dickinson and Company is recalling one lot of BD Trucount tubes because some pouches may contain tubes from a different lot, presenting a low risk to patient safety.

    Product
    BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped…
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1564-2016·2016-05-04

    Hansen Medical Recalls Magellan Robotic Catheter Accessory Kits

    Hansen Medical is recalling eight Magellan Robotic Catheter Accessory Kits because one batch was radiated below the required dose.

    Product
    Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of a Magellan Catheter and an off-the-shelf guide wire while allowing a physician…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1574-2016·2016-05-04

    Synthes Periprosthetic Locking Screw Recalled for Post-Expiration Shipment

    Synthes (USA) Products LLC is recalling 15 units of 5.0 mm Periprosthetic Locking Screws shipped after their expiration date.

    Product
    5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1569-2016·2016-05-04

    Ortho-Clinical enGen Laboratory Automation System Recalled for Electrical Cable Hazard

    Ortho-Clinical Diagnostics is recalling enGen Laboratory Automation Systems because an electrical cable may loosen and cause sample fluid to splash.

    Product
    enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL NAME: enGen (TM) Track System -- NOTE: Outside the US the system is also known as VITROS Automation Solution (VAS) TC Automation System (configured with Thermo…
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-1557-2016·2016-05-04

    Philips Visicu eCareCoordinator Software Error Recall

    Philips Visicu is recalling eCareCoordinator software due to an error that prevents patient task reminders from being generated.

    Product
    eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1527-2016·2016-05-04

    Corin Trinity Acetabular Shell Recalled for Packaging Abrasion Risk

    Corin USA Limited is recalling 629 Trinity Acetabular Shell devices used in total hip replacements due to a potential for abrasion of the sterile barrier pouches in the new packaging system.

    Product
    Trinity Acetabular Shell Product Usage: Total Hip Replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1526-2016·2016-05-04

    Corin Trinity Acetabular System Recalled for Packaging Abrasion Risk

    Corin USA Limited is recalling 629 Trinity Acetabular System devices due to potential abrasion of sterile barrier pouches in the new packaging system.

    Product
    Trinity Acetabular System Product Usage - Total Hip Replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1576-2016·2016-05-04

    Drew Scientific Recalls Drew3-PAC Reagent Packs Due to Platelet Background Issues

    Jas Diagnostics/Drew Scientific is recalling Drew3-PAC reagent packs because they may cause elevated platelet background during routine analyzer checks.

    Product
    Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-1566-2016·2016-05-04

    Stryker PneumoSure Insufflators Recalled for Flow Rate Drop

    Stryker Endoscopy is recalling PneumoSure insufflators because the flow rate drops to zero when connected to a house gas source, suspending insufflation.

    Product
    PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High pressure units (HPU) (40L and 45L). Model Numbers: 620-040-610, 620-040-611, 620-040-613, 620-040-614, 620-040-600, 620-040-601, 620-040-602, 620-040-604, 105-210-684 The Pneumo Sure XL High…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1581-2016·2016-05-04

    LED Technologies Recalls reVive Light Therapy Devices Due to Power Supply Error

    LED Technologies, LLC is recalling 32 units of the reVive Light Therapy Pain Relief Device because an incorrect power supply was included, rendering the devices inoperable.

    Product
    reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product Usage: The reVive Light Therapy Pain Relief Device is a device designed to deliver LED light spectrum in 880nm and 660nm directly into the body tissue to increase circulation and temporarily relieve…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1582-2016·2016-05-04

    Teleflex Pleur-evac Chest Drainage System Recalled for Missing Tyvek Bag Label

    Teleflex Medical is recalling Pleur-evac Chest Drainage Systems because the Tyvek bag label is missing, preventing identification of material code, lot number, and expiration date.

    Product
    Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical. Product Usage: Pleur-Evacs are sterile, single-use, chest drainage systems intended for post-operative use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1529-2016·2016-04-27

    Mevion S250 Proton Therapy System Recalled for Gantry Motion Hazard

    Mevion Medical Systems is recalling five MEVION S250 proton therapy systems because an aperture may fall out during gantry motion, posing a risk of traumatic injury or death to patients.

    Product
    MEVION S250 for Proton Radiation Therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1342-2016·2016-04-27

    Boston Scientific Recalls Fetch 2 Aspiration Catheters Due to Shaft Breaks

    Boston Scientific is recalling Fetch 2 Aspiration Catheters because the catheter shafts may break, potentially requiring additional procedures to remove the broken piece from patients.

    Product
    Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1551-2016·2016-04-27

    Smith & Nephew Recalls TC-PLUS Knee Prosthesis Due to Dimensional Deviation

    Smith & Nephew is recalling 6 units of TC-PLUS tibial knee prostheses due to a dimensional deviation that may prevent the polyethylene insert from seating correctly during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R, REF 12 000 028, S&N 7500283, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1530-2016·2016-04-27

    Acorn 180 Curved Stairlift Recalled Due to Broken Rivets

    Acorn Stairlifts Inc is recalling 1,290 Acorn 180 Curved Stairlifts in the US because aluminum rivets may break under prolonged use.

    Product
    Acorn 180 Curved Stairlift
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1515-2016·2016-04-27

    Ossur Lil Angel Vest Recalled for Potential Plastic Strap Fracture

    Ossur H / F is recalling Lil Angel Vest P3 Sorbatex units because the plastic stabilizer strap may partially or completely fracture.

    Product
    Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1545-2016·2016-04-27

    Smith & Nephew Recalls TC-Plus Tibial Knee Components Due to Dimensional Deviation

    Smith & Nephew is recalling 22 units of TC-Plus tibial knee components distributed in Germany and Switzerland due to a dimensional deviation that may prevent proper seating of the polyethylene insert.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 6 LEFT, STERILE R, REF 12 000 018, S&N 7500273, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1543-2016·2016-04-27

    Smith & Nephew Recalls TC-Plus Tibial Knee Prosthesis Components

    Smith & Nephew is recalling 6 units of TC-Plus tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating of the polyethylene insert during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 0013, S&N 7500268, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1544-2016·2016-04-27

    Smith & Nephew Recalls TC-Plus Tibial Knee Prosthesis Components

    Smith & Nephew is recalling 24 units of TC-Plus tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R, REF 12 000 017, S&N 7500272, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1540-2016·2016-04-27

    Smith & Nephew Recalls TC-Plus Knee Prosthesis Due to Dimensional Deviation

    Smith & Nephew is recalling one unit of a TC-Plus knee prosthesis due to a dimensional deviation that may prevent the polyethylene insert from seating correctly during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 2 RIGHT, STERILE R, REF 12 000 009, S&N 7500264, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1521-2016·2016-04-27

    Siemens CT Systems Recalled for Software Bugs Causing Scan Aborts

    Siemens Medical Solutions is recalling 1,096 CT systems due to software bugs that may cause scan aborts, rescans, or accidental x-radiation.

    Product
    Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1512-2016·2016-04-27

    Ossur Lil Angel Vest Recalled Due to Potential Plastic Strap Fracture

    Ossur H / F is recalling Lil Angel Vest P2 Sorbatex pediatric vests because the plastic stabilizer strap may partially or completely fracture.

    Product
    Ossur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1547-2016·2016-04-27

    Smith & Nephew Recalls TC-PLUS Tibial Knee Prosthesis Components

    Smith & Nephew is recalling 33 units of TC-PLUS tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating of the polyethylene insert during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 4 RIGHT, STERILE R, REF 12 000 024, S&N 7500279, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1549-2016·2016-04-27

    Smith & Nephew Recalls TC-Plus Tibial Knee Prosthesis Components

    Smith & Nephew is recalling 34 units of TC-Plus tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 026, S&N 7500281, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1513-2016·2016-04-27

    Ossur Lil Angel Vest Recalled for Potential Plastic Strap Fracture

    Ossur H / F is recalling Lil Angel Vest P3 Kodel units due to a potential for partial or complete fracture of the plastic stabilizer strap.

    Product
    Ossur Lil Angel Vest P3 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide