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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

27701–27725 of 40233

  • HighFDA (Devices)·Z-1130-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling 185 units of Intact Disposable Wands because the sterile barrier was breached, compromising sterility.

    Product
    Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1131-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers 320 units distributed worldwide.

    Product
    Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1109-2017·2017-02-08

    Immuno-Mycologics Recalls Cryptococcal Antigen Lateral Flow Assay Due to False Positives

    Immuno-Mycologics is recalling 630 units of the Cryptococcal Antigen Lateral Flow Assay because specific lots have lower specificity, leading to reported false positive results.

    Product
    Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1115-2017·2017-02-08

    Zimmer Biomet Recalls Vanguard Total Knee System Femoral Components Due to Labeling Errors

    Zimmer Biomet is recalling Vanguard Total Knee System femoral components because packaging labels may incorrectly identify the size or side of the implant.

    Product
    Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item Number: 183102 Description: VNGD PS OPEN INTL FEM-RT 57.5 Item Number: 183104 Description: VNGD PS OPEN INTL FEM RT 60 Item Number: 183106…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1114-2017·2017-02-08

    Zimmer Biomet Recalls Mislabelled Orthopedic Salvage System Tibial Bodies

    Zimmer Biomet is recalling 16 Orthopedic Salvage System tibial bodies because labels incorrectly identify them as AVL Modular Proximal Tibia components.

    Product
    Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1116-2017·2017-02-08

    Siemens Syngo.plaza PACS Software Recall for Issue Resolution

    Siemens Medical Solutions is recalling 62 Syngo.plaza PACS systems to install a software update that resolves several issues.

    Product
    Syngo.plaza, picture archiving and communications system.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1117-2017·2017-02-08

    Ortho-Clinical VITROS Na+ Slides Recalled for Potential Biased Results

    Ortho-Clinical Diagnostics is recalling VITROS Na+ Slides because they may produce biased results if stored on the analyzer for 10 days after minimum warm-up.

    Product
    VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1118-2017·2017-02-08

    Siemens Mammomat Inspiration Mammography Systems Recalled for Software Error

    Siemens Medical Solutions USA is recalling 55 Mammomat Inspiration digital x-ray mammography systems due to a software error.

    Product
    Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0923-2017·2017-02-01

    Philips Allura Xper FD10 X-ray System Recalled for Loose Screws

    Philips is recalling one Allura Xper FD10 X-ray system because production errors left screws loose, potentially causing the C-arm to rotate uncontrolled.

    Product
    Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1065-2017·2017-02-01

    Villa Radiology Systems Recalls Apollo DRF X-Ray Systems Due to Injury Risk

    Villa Radiology Systems LLC is recalling 66 Apollo DRF multi-function x-ray systems because a chain of faults led to an injury involving inadvertent movement activation.

    Product
    Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-1063-2017·2017-02-01

    Villa Radiology Juno DRF X-ray Systems Recalled for Injury Risk

    Villa Radiology Systems LLC is recalling Juno DRF x-ray systems after an injury occurred due to a chain of faults involving physical barriers and labeling.

    Product
    Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-0925-2017·2017-02-01

    Philips Allura Xper FD20/15 C-arm Recall Due to Loose Screws

    Philips is recalling two Allura Xper FD20/15 systems because production errors may cause C-arm screws to loosen, leading to uncontrolled rotation.

    Product
    Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1064-2017·2017-02-01

    Villa Radiology Systems Recalls Apollo X-Ray Systems Due to Injury Risk

    Villa Radiology Systems LLC is recalling 66 Apollo multi-function x-ray systems after an injury incident involving inadvertent movement activation and delayed emergency stop response.

    Product
    Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-0924-2017·2017-02-01

    Philips Allura Xper FD20 C-arm Recall Due to Loose Screws

    Philips is recalling two Allura Xper FD20 C-arm systems because production errors left screws loose, posing a risk of uncontrolled rotation.

    Product
    Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology(EP).
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1099-2017·2017-02-01

    Roche Recalls Accu-Chek Connect App Due to Insulin Dosing Errors

    Roche Diabetes Care is recalling the Accu-Chek Connect app because software defects may cause incorrect insulin bolus recommendations, potentially leading to hypoglycemia.

    Product
    Accu-Chek Connect Diabetes Management App
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1066-2017·2017-02-01

    Villa Radiology Systems Recalls Apollo EZ X-Ray Systems Due to Injury Risk

    Villa Radiology Systems LLC is recalling 66 Apollo EZ multi-function x-ray systems because a chain of faults caused an injury to a user.

    Product
    Apollo EZ: Model: 9784152036 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-0922-2017·2017-02-01

    Philips Allura Xper FD20 C-arm Recall for Loose Screws

    Philips is recalling one Allura Xper FD20 unit because production errors left screws loose, which could cause the C-arm to rotate uncontrolled.

    Product
    Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1097-2017·2017-02-01

    Softbank II Transfusion Software Recalled for Potential Incorrect Results

    Soft Computer Consultants is recalling Softbank II software due to a software error that may produce incorrect results in transfusion services.

    Product
    SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1077-2017·2017-02-01

    Roche Recalls 30 Cobas b 123 POC Systems for Quality Control Issue

    Roche Diagnostics is recalling 30 cobas b 123 POC systems because a software issue may prevent automatic quality control from running, potentially leading to undetected incorrect test results.

    Product
    Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1076-2017·2017-02-01

    INOmax DSIR Plus Delivery System Recalled for Inaccurate Valve Calibration

    INO Therapeutics is recalling 45 INOmax DSIR Plus delivery systems because an out-of-tolerance manometer may cause inaccurate valve calibration.

    Product
    Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation). The INOmax DSIR uses a dual-channel design to ensure the safe delivery of INOMAX. The first channel has the delivery CPU, the flow controller and…
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1095-2017·2017-02-01

    Baxter Recalls Phoenix Dialysis Machine Preventive Maintenance Kits

    Baxter Healthcare is recalling Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect silicone connectors that may cause fluid leaks.

    Product
    Maintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1074-2017·2017-02-01

    Medline Recalls Unna-Z Compression Wraps Due to Mold Contamination

    Medline Industries is recalling Unna-Z compression wraps due to contamination with common mold species. The recall affects units distributed in the US and several international countries.

    Product
    Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in x 10yds
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1081-2017·2017-02-01

    Atrium Medical Recalls Pediatric Ocean Drains Due to Non-Sterile Packaging

    Atrium Medical is recalling Pediatric Chamber Ocean Drains because the outer packaging is not sterile. The recall covers units with expiration dates prior to October 2019.

    Product
    Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean Infant/Pediatric drain, with in-line connector and suction control stopcock, ¿ in. Tubing, Sims and Pedi connector in bag on back of drain Product Usage: To evacuate air and/or fluid from the chest…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1098-2017·2017-02-01

    Softbank Transfusion Software Recalled for Potential Incorrect Results

    Soft Computer Consultants is recalling Softbank decision support software due to a software error that may produce incorrect results.

    Product
    Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1085-2017·2017-02-01

    Atrium Medical Oasis Dual Chamber Drain Recall Due to Sterility Issue

    Atrium Medical is recalling Oasis dual chamber drains because the outer packaging is not sterile. The recall affects units with expiration dates prior to October 2019.

    Product
    Atrium Medical 3620-100: Oasis dual chamber drain with in-line connectors (2 Patient Tubes) Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum.  To help re-establish lung expansion and restore breathing dynamics.  To facilitate postoperative…
    Category
    Medical Device
    Distribution
    Distributed nationwide