The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

38326–38350 of 50506

  • 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
  • HighNHTSA·15V436000·2015-07-08

    Ford Recalls 2015 Focus, C-Max, and Escape for Engine Shutdown Defect

    Ford is recalling 2015 Focus, C-Max, and Escape vehicles because the engine may continue running after being turned off, increasing the risk of an unintentional crash.

    Product
    FORD — FORD FOCUS, C-MAX, ESCAPE
    Category
    Vehicle
    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
  • HighNHTSA·15V432000·2015-07-07

    Thomas Built Buses Recall Emergency Door Handle Corrosion Defect

    Daimler Trucks North America is recalling 103,038 Thomas Built Buses because corrosion on the emergency door handle stem could delay evacuation during an emergency.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES, THOMAS SAF-T-LINER FS65, SAF-T-LINER CONVENTIONAL, SAF-T-LINER C2, SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V433000·2015-07-07

    Ferrari Recalls 2015 Models Due to Driver Air Bag Assembly Defect

    Ferrari is recalling 814 model year 2015 vehicles because an improperly assembled driver air bag module may deploy in a rotated orientation, increasing injury risk in a crash.

    Product
    FERRARI — FERRARI F12 BERLINETTA, LAFERRARI, 458, CALIFORNIA T
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V434000·2015-07-07

    Fleetwood Southwind Recalled for Missing Emergency Exit Window

    Allied Recreation Group is recalling 2015-2016 Fleetwood Southwind RVs because some may lack a required emergency exit window on the road side bedroom wall.

    Product
    FLEETWOOD — FLEETWOOD SOUTHWIND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V426000·2015-07-06

    Mercedes-Benz Recalls 2014 CLA Models Due to Fuse Installation Error

    Mercedes-Benz is recalling 2014 CLA 250 and CLA 45 AMG vehicles because incorrectly installed fuses may cause airbag and instrument cluster failures.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ CLA250, AMG CLA45
    Category
    Vehicle
    Distribution
    Distributed nationwide