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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24701–24725 of 40397

  • LowFDA (Devices)·Z-0969-2018·2018-03-21

    Randox Recalls Immunoassay Premium Controls Due to Stability Claim Failure

    Randox Laboratories is recalling 117 kits of Immunoassay Premium Controls because the ACTH component does not meet the stated reconstituted stability claim in the product instructions for use.

    Product
    Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0997-2018·2018-03-21

    Arrow International Recalls Central Venous Catheter Kits Due to Missing Labels

    Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot numbers, expiration dates, and UDI information.

    Product
    Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central…
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1003-2018·2018-03-21

    Arrow International Recalls CVC Kits Missing UDI Stickers

    Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot numbers, expiration dates, and UDI information.

    Product
    AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of…
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-0936-2018·2018-03-21

    Medtronic Recalls Argyle Suction Tubing Due to Incorrect Packaging Labeling

    Medtronic is recalling 58,954 units of Argyle Suction Tubing because some pouches may be incorrectly labeled as Salem Sump Dual Lumen Stomach Tubes.

    Product
    Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used as an extension for different types of devices in an operating room, bonded with 2 female sure grip connectors at each end of the tube to facilitate the plug/ insertion of the device…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1013-2018·2018-03-21

    Stryker T/Pump Temperature Therapy Pumps Recalled for Manual Error

    Stryker is recalling T/Pump temperature therapy pumps because the operations and maintenance manuals incorrectly added a sentence to the Indications for Use statement.

    Product
    T/Pump temperature therapy pump, Models TP700 and TP700C
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-0999-2018·2018-03-21

    Arrow International Recalls CVC Kits Missing Lot and UDI Information

    Arrow International Inc is recalling 23,904 AGB+ Pressure Injectable Quad-Lumen CVC Kits because some units are missing stickers containing lot number, expiration date, and UDI information.

    Product
    AGB+ Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of…
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-0998-2018·2018-03-21

    Arrow International Recalls CVC Kits Missing Lot Number Stickers

    Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot number, expiration date, and UDI information.

    Product
    AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of…
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1000-2018·2018-03-21

    Arrow International Recalls Central Venous Access Kits Due to Missing Labels

    Arrow International is recalling 23,904 central venous access kits because some units may be missing stickers with lot numbers, expiration dates, and UDI information.

    Product
    ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple…
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1002-2018·2018-03-21

    Arrow International Recalls Arrowg+ard Blue Catheters Due to Missing Labels

    Arrow International Inc. is recalling 23,904 Arrowg+ard Blue central venous catheters because some units are missing stickers with lot, expiration, and UDI information.

    Product
    ARROWg+ard Blue Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or…
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-0978-2018·2018-03-21

    Philips HeartStart XL+ Defibrillator Software Update Recall

    Philips is recalling 4,315 HeartStart XL+ defibrillators in China to update software that improves device readiness information.

    Product
    HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation. It must be used…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0970-2018·2018-03-21

    Randox Immunoassay Premium Plus Controls Recalled for Stability Issues

    Randox Laboratories is recalling Immunoassay Premium Plus Controls because the ACTH component does not meet the stability claims in the product instructions.

    Product
    Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1001-2018·2018-03-21

    Arrow International Recalls CVC Kits Missing Lot Number Stickers

    Arrow International is recalling 23,904 Arrowg+ard Blue Large-Bore Multi-Lumen CVC Kits because some units may be missing stickers containing lot numbers, expiration dates, and UDI information.

    Product
    ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of…
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1004-2018·2018-03-21

    Arrow International Recalls CVC Kits Missing Lot and UDI Stickers

    Arrow International Inc. is recalling 23,904 Arrowg+ard BLUE PLUS CVC Kits because some units are missing stickers containing lot numbers, expiration dates, and UDI information.

    Product
    ARROWg+ard BLUE PLUS Pressure Injectable Two- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple…
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-0996-2018·2018-03-21

    Arrow PICC Kits Recalled for Missing Lot and Expiration Labels

    Arrow International is recalling 23,904 PICC kits because some units are missing stickers with lot numbers, expiration dates, and UDI information.

    Product
    Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central…
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0908-2018·2018-03-14

    FDA Recalls 163 Endo GIA Radial Reloads Due to Manufacturing Error

    The FDA is recalling 163 Endo GIA Radial Reloads with Tri-Staple Technology because the device cartridge disengaged during use due to a manufacturing error.

    Product
    Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0909-2018·2018-03-14

    Roche cobas 6000 Modular Series System Warning Added to Prevent Operator Injury

    Roche Diagnostics is adding a warning to cobas 6000 and 8000 Modular Series Operator Manuals to prevent operator injury during maintenance.

    Product
    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0922-2018·2018-03-14

    Abbott ARCHITECT c8000 Cuvette Segment Recall for False Test Results

    Abbott is recalling ARCHITECT c8000 Cuvette Segments because a detached post can cause falsely depressed patient results on c4000, c8000, and c16000 instruments.

    Product
    ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinical Chemistry system. There are 11 segments with each cuvette segment holding 15 cuvettes for a total of 165 cuvettes per reaction carousel. The firm name on the label is Abbott…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0903-2018·2018-03-14

    Synthes Reaming Rods Recalled for Potential Sterility Seal Defects

    Synthes (USA) Products LLC is recalling 1,144 sterile 2.5 mm Reaming Rods due to potential gaps in the package seal that may compromise sterility.

    Product
    2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0923-2018·2018-03-14

    Abbott Recalls ARCHITECT c16000 Cuvette Segments Due to Falsely Depressed Results

    Abbott Laboratories is recalling cuvette segments for the ARCHITECT Clinical Chemistry system because detached segment posts may cause falsely depressed patient test results.

    Product
    ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clinical Chemistry system. There are 15 segments with each cuvette segment holding 11 cuvette pairs (22 cuvettes) for a total of 165 cuvettes pairs or a total of 330 cuvettes (22 cuvettes x 15…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0927-2018·2018-03-14

    Medtronic O-arm O2 Imaging System Recalled for Electrical Shock Risk

    Medtronic is recalling 449 O-arm O2 Imaging Systems because servicing internal components may cause an electrical short, posing a shock hazard to field service technicians.

    Product
    O-arm¿ O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighting 60 lbs or greater and having an abdominal thickness of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0846-2018·2018-03-14

    Mindray A-Series Anesthesia Delivery System Software Recall

    Mindray is recalling 2,875 A-Series anesthesia delivery systems due to a software issue that may apply incorrect settings or skip startup leak tests.

    Product
    A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0844-2018·2018-03-14

    Toshiba Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Bolt Loosening

    Toshiba American Medical Systems is recalling 29 INFX-8000V and INFINIX CF-I/BP PLUS systems because fastening bolts on the ceiling drive loosened, disabling operation.

    Product
    INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0907-2018·2018-03-14

    Synthes Recalls Sterile Light Clip for Oracle Retractor Due to Potential Lack of Sterility

    Synthes (USA) Products LLC is recalling sterile Light Clips for the Oracle Retractor because potential gaps in the package seal may compromise sterility. The product is used during orthopedic surgery.

    Product
    Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0847-2018·2018-03-14

    Mindray A7 Anesthesia Delivery System Recalled for Software Defect

    Mindray is recalling A7 Anesthesia Delivery Systems because a software issue may cause incorrect settings to be applied or the startup leak test to be skipped.

    Product
    A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient s ventilation. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0919-2018·2018-03-14

    Zimmer Biomet Recalls Sirus Drill Instruments Due to Cleaning Concerns

    Zimmer Biomet is recalling 127 Sirus Drill instruments because they may not be adequately cleaned, potentially leading to infection.

    Product
    Sirus Drill 13mm diameter trauma instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 02.00020.040
    Category
    Medical Device
    Distribution
    32 states