The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

13001–13025 of 21617

  • 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 (Drugs)·D-0624-2017·2017-04-05

    Sensodyne Toothpaste Recalled for Foreign Substance and Off-Flavor Complaints

    GSK Consumer Healthcare is recalling Sensodyne Repair & Protect Whitening toothpaste due to the presence of a foreign substance and low concentration of patchouli oil, causing off-flavor and scent complaints.

    Product
    SENSODYNE — SENSODYNE (STANNOUS FLUORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1737-2017·2017-04-05

    Give and Go Recalls Pecan Tarts Due to Weevil Larvae

    Give and Go Prepared Foods is recalling Two-Bite Pecan Tarts because dried weevil larvae may be present in the product.

    Product
    Two-Bite Pecan Tarts Party Platter 16 x 16.2 (460g) item number 09877
    Category
    Food
    Distribution
    Distributed nationwide
  • 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
  • ModerateFDA (Devices)·Z-1540-2017·2017-03-29

    Hitachi Oasis MRI System Recalled for Image Data Transfer Errors

    Hitachi Medical Systems America Inc is recalling 210 Hitachi Oasis MRI Systems because image data transferred to workstations showed errors on the slice position reference image.

    Product
    Hitachi Oasis MRI System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1512-2017·2017-03-29

    Devicor Mammotome Revolve Biopsy System Recalled for Missing Labeling

    Devicor Medical Products Inc is recalling 320 Mammotome Revolve Dual Vacuum Assist Biopsy Systems because they lack required probe labeling, product codes, and sterilization stickers.

    Product
    Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1487-2017·2017-03-29

    Crossroads MotoCLIP Super Elastic Fusion System Recalled for Incorrect Sizing

    Crossroads Extremity Systems is recalling 20 units of MotoCLIP Super Elastic Fusion Systems because seven implants were incorrectly sized and labeled.

    Product
    MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1528-2017·2017-03-29

    BioMerieux Recalls ETEST Fosfomycin Strips Due to Unsupported Shelf-Life Claims

    BioMerieux SA is recalling ETEST Fosfomycin FM1024 strips because internal testing does not support the current shelf-life claims.

    Product
    ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM 0.064-1024. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1536-2017·2017-03-29

    MedComp Recalls 9.6F CT Ports with Incorrect Introducer Size

    Medical Components, Inc. is recalling 71 units of 9.6F CT Ports because they were packaged with 9F introducers instead of the labeled 10F size, preventing proper insertion.

    Product
    9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1521-2017·2017-03-29

    BioMerieux Recalls ETEST Ceftazidime Strips Due to Stability Issues

    BioMerieux SA is recalling ETEST Ceftazidime TZ256 strips because their shelf-life claims are not supported by internal testing.

    Product
    ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.016-256. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1541-2017·2017-03-29

    Hitachi Echelon Oval MRI System Recalled for Image Data Errors

    Hitachi Medical Systems America Inc is recalling 25 Hitachi Echelon Oval MRI Systems because image data transferred to workstations showed errors on the slice position reference image.

    Product
    Hitachi Echelon Oval MRI System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1500-2017·2017-03-29

    Haag-Streit EyeSuite Software Recalled for Potential Patient Data Misattribution

    Haag-Streit USA Inc is recalling EyeSuite i.8.2.1.0 software due to a risk that patient data may be stored under the wrong patient on the DICOM Server.

    Product
    EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1415-2017·2017-03-29

    Merge Cardio Software Recall Due to Missing Read-Only Notification

    Merge Healthcare is recalling Merge Cardio software versions 9.0.9 and earlier because a defect allows two physicians to access the same study report without a read-only prompt.

    Product
    Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1486-2017·2017-03-29

    Merge Healthcare Recalls Cardio Software Due to STAT Study Display Issue

    Merge Healthcare is recalling Merge Cardio software versions 9.0 through 10.1.2 because the study list fails to display STAT studies without a manual refresh.

    Product
    Merge Cardio software.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1542-2017·2017-03-29

    Hitachi Echelon MRI System Recalled for Image Data Transfer Errors

    Hitachi Medical Systems America Inc is recalling 68 Hitachi Echelon MRI Systems because image data transferred to workstations showed errors on the slice position reference image.

    Product
    Hitachi Echelon MRI System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1533-2017·2017-03-29

    Siemens Syngo.plaza PACS Systems Recalled for Software Update Issues

    Siemens Medical Solutions is recalling 13 Syngo.plaza PACS systems nationwide due to software update issues. The recall is voluntary and has been terminated.

    Product
    Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1532-2017·2017-03-29

    BioMerieux Recalls ETEST Ceftriaxone Strips Due to Stability Issues

    BioMerieux SA is recalling ETEST Ceftriaxone strips because their shelf-life claims are not supported by internal testing. The products were distributed worldwide.

    Product
    ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1638-2017·2017-03-29

    Jugos La Morovena Lemon Juice Recalled for Missing Phenylalanine Warning

    Jugos y Agua La Morovena Inc. is recalling lemon juice in Puerto Rico because the labels lack the required warning for people with phenylketonuria.

    Product
    Jugos La Morove¿a, Lim¿n (Lemon) ,Elaborado y Envasado por Jugos La Morove¿a, Carr 634 km 5.1, Bo. Franquez, Morovis PR 00687
    Category
    Food
    Distribution
    1 state