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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27251–27275 of 40233

  • HighFDA (Devices)·Z-1612-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 158 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800551003, Sterile, GS0640C - Lap Chole - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1643-2017·2017-04-05

    Resource Optimization Recalls Sterile C-Section Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 430 sterile C-section kits because a light glove component may split, breaking the sterile field.

    Product
    Regard, Item Number: 800408004, Sterile, LD0477D - C-Section PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1620-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 120 sterile custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800557002, Sterile, LD0646B - C Section - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1649-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Sterile Field Compromise

    Resource Optimization & Innovation Llc is recalling 436 Regard custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800411003, Sterile, NU0480C- Neuro PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1662-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Sterile Field Breach Risk

    Resource Optimization & Innovation LLC is recalling 350 Regard custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800419002, Sterile, GY0488B - D&C Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1626-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 189 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800559002, Sterile, ET0648B - Head & Neck - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1569-2017·2017-04-05

    Resource Optimization Recalls 18 Sterile Total Hip Procedure Trays

    Resource Optimization & Innovation LLC is recalling 18 sterile total hip procedure trays because a light glove component can split and break the sterile field.

    Product
    Regard, Item Number: 880330003, Sterile, OR0761C - Total Hip - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1559-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 156 Regard custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 880323001, Sterile, LD0754A - C Section - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1635-2017·2017-04-05

    Recall of Sterile Robotic Laparoscopic Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 92 sterile robotic laparoscopic procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1648-2017·2017-04-05

    Recall of Regard Sterile Neuro PK Spohn Procedure Trays

    Resource Optimization & Innovation Llc is recalling 1,056 sterile procedure trays because a light glove component can split and break the sterile field.

    Product
    Regard, Item Number: 800411002, Sterile, NU0480B- Neuro PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1567-2017·2017-04-05

    Recall of Pacemaker Procedure Kits Due to Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 28 sterile pacemaker procedure kits because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 880328001, Sterile, HT0759A - Pacemaker Pk - OSU
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1703-2017·2017-04-05

    Siemens Dimension Vista Lab Systems Recalled for Potential ECREA Test Inaccuracy

    Siemens is recalling Dimension Vista 500 and 1500 lab systems because ECREA test results may be falsely elevated in isolated cases.

    Product
    Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer, chemistry (photometric, discrete), for clinical use Product Usage: The Siemens Healthcare Diagnostics Dimension Vista System is an in vitro diagnostic device intended to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1690-2017·2017-04-05

    Nonin 8500M Handheld Pulse Oximeters Recalled for Incorrect Memory Board

    Nonin Medical is recalling 15 units of the 8500M Handheld Pulse Oximeter because some devices may contain an incorrect pulse oximetry board lacking the integrated memory feature.

    Product
    8500M Handheld Pulse Oximeter
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1688-2017·2017-04-05

    Siemens Syngo.x PACS Software Recalled for Addressing Multiple Issues

    Siemens Medical Solutions is recalling 104 Syngo.x PACS systems to install software updates that address several unspecified issues.

    Product
    Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1694-2017·2017-04-05

    Medtronic Recalls Single SynchroMed II Implantable Drug Infusion Pump

    Medtronic is recalling one SynchroMed II implantable drug infusion pump in Illinois due to a programmer error code that prevented updates.

    Product
    SynchroMed II implantable drug infusion pump, Model 8637-40,
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1689-2017·2017-04-05

    Siemens Syngo.via Software Recall for Medical Image System Issues

    Siemens Medical Solutions is recalling 104 units of Syngo.via picture archiving software to address several identified issues.

    Product
    Syngo.via, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1693-2017·2017-04-05

    Baxter SIGMA Spectrum Infusion Pump Software Anomaly Recall

    Baxter is recalling SIGMA Spectrum Infusion Pumps with Master Drug Library due to a software anomaly that may cause a Sharp Watchdog Timeout error.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1701-2017·2017-04-05

    Biomet 3i Recalls Dental Implants Due to Potential Label Mismatch

    Biomet 3i is recalling five units of LTX dental implants because a single part in the lot may not match the label due to a supplier error.

    Product
    BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile"
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1681-2017·2017-04-05

    Merge Eye Care Systems Software Recall Due to Image Acquisition Failure

    Merge Healthcare is recalling Eye Care Systems software because incompatible versions prevent the downloading or acquisition of new images.

    Product
    Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1686-2017·2017-04-05

    Focus Diagnostics Legionella IFA Substrate Slide Recalled for Regulatory Status

    Focus Diagnostics is recalling Legionella IFA Substrate Slides because the device was found not to be 510(k) exempt.

    Product
    Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-1685-2017·2017-04-05

    Focus Diagnostics Legionella IFA Recalled for Regulatory Status Error

    Focus Diagnostics is recalling Legionella IFA devices because the company discovered the product is not 510(k) exempt. The recall affects 196 units distributed to three testing laboratories.

    Product
    Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-1698-2017·2017-04-05

    AGFA DX-D100 X-Ray System Recalled for Missing Allen Wrench Storage Instructions

    AGFA Healthcare Corp. is recalling 308 DX-D100 Digital Radiography X-Ray Systems because the user manual did not specify where to store the Allen wrench used for manual movement.

    Product
    AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis
    Category
    Medical Device
    Distribution
    35 states
  • SevereFDA (Devices)·Z-1505-2017·2017-03-29

    Ohmeda Medical Recalls Giraffe Incubators Due to Power Cord Overheating

    Ohmeda Medical is recalling Giraffe Incubators because certain power cords may overheat, posing a risk of fire or thermal injury.

    Product
    Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1501-2017·2017-03-29

    Ohmeda Giraffe Exam Light Recalled Due to Power Cord Overheating Risk

    Ohmeda Medical is recalling Giraffe Exam Lights because certain power cords may overheat, posing a risk of fire, smoke, or thermal injury.

    Product
    Giraffe Exam Light The Exam Light illuminates body surfaces and facilitates patient observation during a medical examination. It increases ambient light to facilitate performance of procedures on the mattress field. It is designed to mount on the accessory railings of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1509-2017·2017-03-29

    Ohmeda Medical Recalls Giraffe OmniBed Infant Incubators Due to Fire Risk

    Ohmeda Medical is recalling Giraffe OmniBed infant incubators and warmers because certain power cords may overheat, posing a risk of fire or thermal injury.

    Product
    Giraffe OmniBed Ohmeda Medical Omnibed- The OmniBed is a combination of an infant incubator ( incubator ) and an infant radiant warmer ( warmer ). Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own…
    Category
    Medical Device
    Distribution
    Distributed nationwide