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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

27301–27325 of 40233

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-1490-2017·2017-03-29
Siemens Recalls 80 Oncor Avant-Garde Radiation Therapy Systems for Software Update
Siemens Medical Solutions is voluntarily recalling 80 Oncor Avant-Garde radiation therapy systems to install a software update. The devices were distributed throughout the United States.
Product
ONCOR" Avant-garde
Category
Medical Device
Distribution
0 states
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-1489-2017·2017-03-29
Siemens Recalls 80 Mevatron M2/Primus Mid-Energy Systems for Software Update
Siemens Medical Solutions USA is recalling 80 Mevatron M2/Primus Mid-Energy systems to apply a software update. The recall was initiated voluntarily by the firm.
Product
Mevatron M2/Primus Mid-Energy PRIMUS HI
Category
Medical Device
Distribution
0 states
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
ModerateFDA (Devices)·Z-1493-2017·2017-03-29
Philips Recalls Brilliance BigBore CT Scanners Due to Image Reconstruction Error
Philips is recalling 67 Brilliance BigBore CT scanners because 4D CT images may be reconstructed at a single phase while incorrectly labeled as specific phases.
Product
Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display…
Category
Medical Device
Distribution
22 states
ModerateFDA (Devices)·Z-1522-2017·2017-03-29
BioMerieux Recalls ETEST Cephalothin CE 256 Foam Packaging Due to Stability Issues
BioMerieux SA is recalling ETEST Cephalothin CE 256 Foam packaging because current shelf-life claims are not supported by internal testing.
Product
ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 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-1495-2017·2017-03-29
Zimmer Biomet Recalls Orthosize Templating Software Due to Incorrect Files
Zimmer Biomet is recalling Orthosize Templating Version 1.2.6 digital templates because they were created with incorrect files, affecting preoperative planning for orthopedic surgery.
Product
Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1530-2017·2017-03-29
BioMerieux Recalls ETEST Gentamicin Strips Due to Stability Issues
BioMerieux SA is recalling ETEST Gentamicin antimicrobial susceptibility testing strips because their shelf-life claims are not supported by internal testing.
Product
ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-256(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-1526-2017·2017-03-29
BioMerieux Recalls ETEST Doripenem Strips Due to Stability Issues
BioMerieux SA is recalling ETEST Doripenem DOR32 FOAM packaging strips because internal testing does not support the current shelf-life claims.
Product
ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1535-2017·2017-03-29
Tearscience LipiFlow System Recalled for Inconsistent Storage Temperature Labeling
Tearscience is recalling LipiFlow Thermal Pulsation Systems because the labeled storage temperature does not match tested conditions for the full shelf life.
Product
LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1529-2017·2017-03-29
BioMerieux Recalls ETEST Imipenem IP32 Foam Packaging Due to Stability Issues
BioMerieux SA is recalling ETEST Imipenem IP32 Foam packaging because the current shelf-life claims are not supported by internal testing.
Product
ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1484-2017·2017-03-29
FDA Recalls Microbore Extension Sets Due to Incorrect Priming Volume Labeling
Vygon MFG is recalling 30,700 AMS-636 Microbore extension sets because the package displays an incorrect priming volume.
Product
AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1531-2017·2017-03-29
BioMerieux Recalls ETEST Tobramycin Strips Due to Stability Issues
BioMerieux SA is recalling ETEST Tobramycin antimicrobial susceptibility testing strips because their shelf-life claims are not supported by internal testing.
Product
ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.016-256(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-1525-2017·2017-03-29
BioMerieux Recalls ETEST Vancomycin Strips Due to Stability Issues
BioMerieux SA is recalling ETEST Vancomycin antimicrobial susceptibility testing strips because their shelf-life claims are not supported by internal testing.
Product
ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 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-1537-2017·2017-03-29
Siemens ADVIA Centaur XPT Software Recall for Workflow Issues
Siemens is recalling ADVIA Centaur XPT software versions V1.0.1 through V1.2 due to issues that may delay testing and affect system workflow.
Product
ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADVIA Centaur XPT System is a stand-alone, continuous operation, immunochemistry analyzer that performs the following functions: aspirates and dispenses samples; Performs dilutions; Adds…
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-1527-2017·2017-03-29
BioMerieux Recalls Etest Benzyl Penicillin Strips Due to Stability Issues
BioMerieux SA is recalling Etest Benzyl Penicillin PG256 FOAM packaging because shelf-life claims are not supported by internal testing.
Product
ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenicillin PG 0.016-256 (high). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae…
Category
Medical Device
Distribution
Distributed nationwide

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27301–27325 of 40233