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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27751–27775 of 40357

  • HighFDA (Devices)·Z-1180-2017·2017-02-15

    Merge RadSuite software recalled due to incorrect pixel value data

    Merge Healthcare is recalling RadSuite software version V8.30.7.8 because incorrect pixel values may lead to patient injury or delayed diagnosis.

    Product
    Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1142-2017·2017-02-15

    Merge Healthcare Recalls Eye Station Imaging Devices Due to Capture Failures

    Merge Healthcare is recalling 182 Eye Station capture stations because they may fail to capture eye images as intended, posing a risk to patient health.

    Product
    Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1148-2017·2017-02-15

    AtriCure Recalls AtriClip LAA Exclusion System Due to Jaw Breakage

    AtriCure is recalling 464 AtriClip LAA Exclusion System devices because a complaint was received regarding the PRO2 jaw breaking prior to surgery.

    Product
    AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a conventional thermoformed polyethylene terephthalate glycol (PETG) tray with a Tyvek¿ lid. A single-walled non-corrugated box completes the single unit package. Six (6)…
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-1176-2017·2017-02-15

    Merge PACS Software Recalled for Potential Incorrect Patient Image Display

    Merge Healthcare is recalling Merge PACS software version 7.0.1 because it may display incorrect patient images, potentially delaying diagnosis or treatment.

    Product
    Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-1177-2017·2017-02-15

    Teleflex Recalls Sheridan Cuffed Tracheal Tubes Due to Labeling Inconsistency

    Teleflex Medical is recalling Sheridan cuffed tracheal tubes because some units are labeled with incorrect sizes, potentially leading to improper airway management.

    Product
    Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed Tracheal Tube, Catalog # 5-10315 A tracheal tube is inserted into a patients mouth or nose for airway management
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-1143-2017·2017-02-15

    Physio-Control Recalls LIFEPAK 12 Defibrillators with Erratic CO2 Readings

    Physio-Control is recalling LIFEPAK 12 Defibrillators because the End-Tidal CO2 reading may intermittently display an invalid value of XXX during operation.

    Product
    LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical). The device is also used…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1150-2017·2017-02-15

    Stryker Leibinger Recalls Non-Sterile Medpor Implant Sizer Sets Due to Labeling Error

    Stryker Leibinger is recalling specific non-sterile Medpor implant sizer sets because they were incorrectly labeled as sterile. The recall covers 619 units distributed in the US and several international countries.

    Product
    9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Accessories to Medpor Implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1140-2017·2017-02-15

    Siemens Dimension Ammonia Reagent Cartridges Recalled for Calibration Issues

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Ammonia Flex reagent cartridges because they may not meet the 60-day calibration interval claim, potentially leading to abnormal assay results.

    Product
    Dimension¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension clinical chemistry system. Ammonia measurements are used in the diagnosis and treatment of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1141-2017·2017-02-15

    Siemens Dimension Vista Ammonia Flex Reagent Cartridge Recall

    Siemens is recalling specific lots of Dimension Vista Ammonia Flex reagent cartridges because they may not meet the 60-day calibration interval claim, potentially resulting in abnormal assay results.

    Product
    Dimension Vista¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension clinical chemistry system. Ammonia measurements are used in the diagnosis and treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1151-2017·2017-02-15

    Vertebral Technologies Recalls InterFuse Tail Traction Tool Due to Fit Issues

    Vertebral Technologies is recalling 63 InterFuse Tail Traction Tools because they may not fit properly with the InterFuse T implant.

    Product
    InterFuse Tail Traction Tool, Part Number 9116. The InterFuse Tail Traction Tool is an optional Class I non-sterile reusable instrument that can be used to assist with module locking of the InterFuse S or InterFuse T implant system. The system has a modular design to allow…
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1181-2017·2017-02-15

    Ortho VITROS FS Calibrator 1 Recalled Due to Calibration Failure

    Ortho-Clinical Diagnostics is recalling VITROS FS Calibrator 1, Lot 91461, because it cannot calibrate dLDL reagents when used with specific Assay Data Disk versions.

    Product
    VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD; used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS/4600 Chemistry and integrated Systems. --- Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1139-2017·2017-02-15

    Encore Medical Recalls Empowr PS Knee Tibial Inserts Due to Missing Feature

    Encore Medical is recalling 24 Empowr PS Knee Tibial Inserts because they are missing the impaction slot feature.

    Product
    Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1179-2017·2017-02-15

    Ortho-Clinical VITROS UPRO Slides Recalled for Variable Urine Protein Results

    Ortho-Clinical Diagnostics is recalling VITROS UPRO Slides because they may produce variable urine protein results.

    Product
    VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1146-2017·2017-02-15

    Thayer MiniSpacer MDI Adapter Recalled for Incorrect Labeling

    Thayer Medical Corporation is recalling 2,550 MiniSpacer MDI adapters because the insert and case labels incorrectly state the connection size.

    Product
    Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections, Reference no. 1543A. The 15 mm Dual Spray MiniSpacer with Counter Incrementing Actuator is a non-sterile, single-use item, intended to dispense aerosolized medication into a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1145-2017·2017-02-15

    FDA Recalls Hotline Blood and Fluid Warmers for Incorrect Language Labeling

    Smiths Medical ASD, Inc. is recalling 33 Hotline Blood and Fluid Warmers distributed to Finland because they included Greek and Danish labeling instead of the required Finnish labeling.

    Product
    HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1136-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling 105 Intact Disposable Wands because the sterile barrier was breached, compromising product sterility.

    Product
    Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm 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
  • SevereFDA (Devices)·Z-1126-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled Due to Sterility Compromise

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

    Product
    Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm 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
  • SevereFDA (Devices)·Z-1132-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall affects 499 units distributed worldwide.

    Product
    Intact Disposable Wands (part of the Intact System) 777-115BT: 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
  • SevereFDA (Devices)·Z-1133-2017·2017-02-08

    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 275 units distributed worldwide.

    Product
    Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm 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-1108-2017·2017-02-08

    PerkinElmer Spare Disk Remover Module Recall Due to Corrosion Risk

    PerkinElmer is recalling Spare Disk Remover Modules because defective axles may corrode in humid conditions, potentially contaminating test plates.

    Product
    Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1110-2017·2017-02-08

    Biom'up Recalls Renovix Collagen Membranes Due to Sterility Assurance Concerns

    Biom'up is recalling 1,682 units of Renovix Guided Healing Collagen Membranes due to a lack of sterility assurance. The products were distributed to a sole distributor in North Carolina.

    Product
    RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1107-2017·2017-02-08

    PerkinElmer Genetic Screening Processor Recalled for Corroding Axles

    PerkinElmer is recalling 24 Genetic Screening Processor instruments because defective ball bushing axles may corrode in humid conditions, risking contamination of sample wells.

    Product
    Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1122-2017·2017-02-08

    Mevion S250 Proton Therapy Units Recalled for Data Loss Error

    Mevion Medical Systems is recalling two S250 Proton Radiation Therapy units because a software error can cause Delta corrections to be lost.

    Product
    MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1128-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall affects 180 units distributed worldwide.

    Product
    Intact Disposable Wands (part of the Intact System) 777-112: 5 Pack 12mm 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