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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27376–27400 of 40357

  • HighFDA (Devices)·Z-1494-2017·2017-03-29

    Nidek EC-5000 Excimer Laser Software Recall for Unintended Correction Programming

    Nidek Inc is recalling Final Fit Software versions 1.11 and 1.12 for the EC-5000 Excimer Laser System because treatment planning could be programmed with an unintended correction.

    Product
    Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1496-2017·2017-03-29

    Merge Cardio software recall due to patient data display error

    Merge Healthcare is recalling Merge Cardio software versions with IPID because the system may display images from different patients as if they belong to the same individual.

    Product
    Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1513-2017·2017-03-29

    Medtronic Poly Component Trial Knee Implants Recalled for Cracked Dovetails

    Medtronic Sofamor Danek USA Inc is recalling 72 units of Poly Component Trial knee implants because the dovetails were observed as cracked or broken.

    Product
    Poly Component Trial, MPCS, packaged in the following sizes and configurations: a) Poly Component Trial - MPCS 3x10L, REF 90-SRK-192310 b) Poly Component Trial - MPCS 3x10R, REF 90-SRK-191310 c) Poly Component Trial - MPCS 3x12L, REF 90-SRK-192312 d) Poly Component Trial…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1539-2017·2017-03-29

    Integra Recalls Panta Nails Due to Potential Sterility Seal Issues

    Integra LifeSciences is voluntarily recalling Panta and Panta XI Nails because package seals may not maintain intended sterility.

    Product
    Panta Nail, Rx only, Sterile,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1516-2017·2017-03-29

    Medtronic Recalls Poly Component Trials Due to Cracked or Broken Dovetails

    Medtronic is recalling 111 units of Poly Component Trials because the dovetails were observed as cracked or broken.

    Product
    Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly Component Trial - PS 3x12, REF 90-SRK-180312 c) Poly Component Trial - PS 3x14, REF 90-SRK-180314 d) Poly Component Trial - PS 4x10…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1514-2017·2017-03-29

    Medtronic Poly Component Trial Knee Implants Recalled for Cracked Dovetails

    Medtronic is recalling 72 Poly Component Trial knee implants because their dovetails were observed as cracked or broken.

    Product
    Poly Component Trial, UCCS, packaged in the following sizes and configurations: a) Poly Comp Trial - UCCS 3x10, REF 90-SRK-170310 b) Poly Comp Trial - UCCS 3x12, REF 90-SRK-170312 c) Poly Comp Trial - UCCS 3x14, REF 90-SRK-170314 d) Poly Comp Trial - UCCS 4x10, REF…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1543-2017·2017-03-29

    Medtronic Recalls Endurant Bifurcated Stent Grafts Due to Fabric Permeability

    Medtronic is voluntarily recalling specific Endurant and Endurant II bifurcated stent graft systems because fabric permeability variations may be associated with endoleaks during initial implant procedures.

    Product
    Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E ETBF2513C166E ETBF2313C166E ETBF2316C166E ETBF2313C124E ETBF2513C145E ETBF2516C124E ETBF2316C124E ETBF2513C124E.…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1485-2017·2017-03-29

    PureWick External Catheter Recalled for Latex Labeling Errors

    Purewick Corporation is recalling 176,863 units of the PureWick External Catheter for Women because the labeling failed to disclose the presence of dry natural rubber and incorrectly stated the product was latex-free.

    Product
    PureWick External Catheter for Women-Wick Product Usage: A flexible, contoured external catheter (a Wick) is positioned between the labia and gluteus muscles. The function of the Wick is to draw urine away from the body through the Wick to a storage container away from the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-1491-2017·2017-03-29

    Siemens Recalls 80 ONCOR MRI Systems for Software Update

    Siemens Medical Solutions is voluntarily recalling 80 ONCOR MRI systems nationwide to install a software update.

    Product
    ONCOR" Expression ONCOR" Impression ONCOR" Impression plus
    Category
    Medical Device
    Distribution
    0 states