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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32801–32825 of 40449

  • HighFDA (Devices)·Z-1899-2015·2015-07-08

    Covidien Recalls Chronic Catheter Kits for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048CP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z1855-2015·2015-07-08

    Palindrome SI Chronic Catheter Sport Pack Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome SI Chronic Catheter Sport Packs because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 23 cm Item Code: 8888223408
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1937-2015·2015-07-08

    Atrium Medical Recalls Oasis Chest Drains Due to Missing O-Ring

    Atrium Medical Corporation is recalling Oasis Dry Suction Water Seal Chest Drains because they have a missing o-ring. The recall covers 1,170 cases distributed nationwide and in Canada and Germany.

    Product
    Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1850-2015·2015-07-08

    Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1936-2015·2015-07-08

    Atrium Medical Recalls Ocean Water Seal Chest Drains Due to Missing O-Ring

    Atrium Medical Corporation is recalling Ocean Water Seal Chest Drains because they have a missing o-ring. The recall covers 130 cases distributed nationwide and in Canada and Germany.

    Product
    Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1947-2015·2015-07-08

    BioMerieux Etest Cefotaxime CT 256 In Vitro Diagnostic Recall

    BioMerieux SA is recalling Etest Cefotaxime CT 256 in vitro diagnostic devices because quality control results were out of range, potentially causing false resistant strain results.

    Product
    Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1866-2015·2015-07-08

    Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1849-2015·2015-07-08

    Varian VariSource iX Afterloader Systems Recalled for Calculation Errors

    Varian Medical Systems is recalling 55 VariSource iX afterloader systems because a software freeze can cause incorrect radiation dose calculations.

    Product
    The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1956-2015·2015-07-08

    JustRight 5mm Stapler Reloads Recalled for Incomplete Staple Formation

    Justright Surgical is recalling JustRight 5mm Stapler Reloads because they may deliver incomplete staple formation and incomplete tissue closure.

    Product
    JustRight 5mm Reload, JR-REL25-2.0 Reload is packaged in cases of 12., placed in a tray and sealed with a Tyvek lid. Product Usage: The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric, and thoracic surgery for the resection, transection, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1943-2015·2015-07-08

    US Endoscopy Recalls Velocity Biopsy Valves Due to Structural Defect

    US Endoscopy Group Inc is recalling Velocity Biopsy Valves because the valve body and irrigation tube may separate during use.

    Product
    Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velocity biopsy valve provides access for endoscopic device passage and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1860-2015·2015-07-08

    FDA Recalls Palindrome SI Chronic Catheter Kits for Antimicrobial Defects

    The FDA is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1898-2015·2015-07-08

    Palindrome Precision HSI Chronic Catheter Kit Recalled for Antimicrobial Failure

    Covidien LLC is recalling specific lots of Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications.

    Product
    Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1903-2015·2015-07-08

    FDA Recalls Palindrome Precision HSI Chronic Catheter Kits for Antimicrobial Issues

    FDA is recalling Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units distributed in the US and internationally.

    Product
    Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050CP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1896-2015·2015-07-08

    FDA Recalls Palindrome HSI Chronic Catheter Kits for Antimicrobial Spec Failure

    The FDA is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall covers 72,363 units in the US and 24,631 units internationally.

    Product
    Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1891-2015·2015-07-08

    Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1945-2015·2015-07-08

    Biomet Gentle Threads Interference Screw Recall Due to Product Mix-Up

    Biomet is recalling Gentle Threads Interference Screws because two different part numbers were mixed. Using the incorrect screw may lead to failure or revision surgery.

    Product
    Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1972-2015·2015-07-08

    Siemens Recalls Syngo Imaging Software Due to Display and Measurement Errors

    Siemens is recalling Syngo Imaging software versions V30 and V31 because safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non-square pixel size.

    Product
    SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1953-2015·2015-07-08

    Sheffield Pharmaceuticals Recalls LUBRI GEL Due to B. cepacia Contamination

    Sheffield Pharmaceuticals is recalling specific lots of Dr. Sheffield's LUBRI GEL personal lubricant after testing revealed high counts of gram-positive rods and B. cepacia.

    Product
    Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1973-2015·2015-07-08

    GE Healthcare Recalls Optima IGS 320 Angiographic X-ray Systems

    GE Healthcare is recalling three Optima IGS 320 angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.

    Product
    GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1935-2015·2015-07-08

    Atrium Medical Recalls Ocean Water Seal Chest Drains Due to Missing O-Ring

    Atrium Medical Corporation is recalling Ocean Water Seal Chest Drains because they have a missing o-ring. The recall covers 390 cases distributed nationwide, in Canada, and in Germany.

    Product
    Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1895-2015·2015-07-08

    Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    FDA is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1876-2015·2015-07-08

    Palindrome Precision SI Chronic Catheter Kit Recalled for Antimicrobial Specification

    The FDA is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 8888146144P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1914-2015·2015-07-08

    Medtronic Recalls DLP Femoral Arterial Cannulas Due to Connection Issues

    Medtronic is recalling specific lots of DLP Femoral Arterial Cannulas because users reported difficulty connecting the device to perfusion circuit tubing.

    Product
    Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021. Sterilized using Ethylene Oxide. The cannula and dilator components are polyurethane and have tapered proximal tips to aid in diameter…
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-1984-2015·2015-07-08

    GE Healthcare Recalls Innova IGS 630 Angiographic X-ray Systems

    GE Healthcare is recalling eight Innova IGS 630 angiographic X-ray systems due to a potential safety issue that may cause the loss of C-arm gantry motion capability.

    Product
    GE Healthcare Innova IGS 630. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide