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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27651–27675 of 40233

  • ModerateFDA (Devices)·Z-1198-2017·2017-02-22

    Arthrex Shoulder Suspension Tower Recalled for Loose Screw Risk

    Allen Medical Systems is recalling 112 Arthrex Shoulder Suspension Towers because fastening screws may come loose and enter the sterile field.

    Product
    Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex Lateral Decubitus Shoulder Positioner is intended to allow for the controlled manipulation of the arm and shoulder joint during arthroscopic surgical procedures.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1196-2017·2017-02-22

    Argon Medical Devices Recalls Harvest Needles Due to Sterility Concerns

    Argon Medical Devices is recalling 15 boxes of Harvest Needles because a potential defect in the blister packaging may compromise the sterility of the product.

    Product
    HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow specimens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1216-2017·2017-02-22

    Siemens Enzyme 2 Calibrator Recalled for Positive Result Shifts

    Siemens Healthcare Diagnostics is recalling Enzyme 2 Calibrators because they may cause patient and QC results to shift up to 10% when used with the Dimension Vista System.

    Product
    The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransferase (AST) methods on the Dimension Vista System. For prescription use only.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1183-2017·2017-02-15

    Invacare Recalls Bariatric Beds Due to Fire Hazard

    Invacare is recalling Bariatric Beds (BARPKG-IVC 1633) because a quality issue with the junction box may cause sparks and result in a fire.

    Product
    Bariatric Bed - BARPKG-IVC 1633
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1185-2017·2017-02-15

    Invacare Bariatric Bed Junction Box Recalled for Fire Risk

    Invacare is recalling 161 bariatric bed junction boxes due to a quality issue that may cause sparks and result in a fire.

    Product
    Junction Box - 1104343 and 1193560
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1182-2017·2017-02-15

    Invacare Bariatric Bed Recall Due to Fire Hazard

    Invacare is recalling 411 bariatric beds because the junction box may emit sparks and cause a fire.

    Product
    Bariatric Bed - BAR600IVC
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1184-2017·2017-02-15

    Invacare Recalls Bariatric Bed Foot Sections Due to Fire Risk

    Invacare Corporation is recalling 292 bariatric bed foot sections because a quality issue with the junction box may cause sparks and result in a fire.

    Product
    Foot Section - BAR5490IVC
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1138-2017·2017-02-15

    Carestream DRX-Revolution Mobile X-Ray System Recalled for Brake Failure

    Carestream Health is recalling DRX-Revolution Mobile X-Ray Systems because a complaint alleged the unit could not be stopped when applying the brake, resulting in a crash into an elevator.

    Product
    Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1137-2017·2017-02-15

    AngioDynamics Recalls Celerity ECG Cable Accessory Packs Due to Soldering Defect

    AngioDynamics is recalling Celerity ECG Cable Accessory Packs because the ECG clip cable may not be soldered correctly, potentially preventing the device from conducting ECG signals.

    Product
    Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics UPN/Product No. H787471431, REF/Catalog No. 47-143 -- Legal Manufacturer: AngioDynamics, Inc. 10 Glens Falls Technical Park, Glens Falls, NY 12801; and (b) medCOMP…
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0927-2017·2017-02-15

    Bayer Recalls Medrad Intego PET Infusion System Pumps

    Bayer is recalling Medrad Intego PET Infusion System pumps because the administration sets may produce particulates in radiopharmaceutical vials.

    Product
    MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. It is also intended to provide effective…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1178-2017·2017-02-15

    Boston Scientific Recalls EMBLEM S-ICD Programmer Model 3200

    Boston Scientific is recalling 4,500 EMBLEM S-ICD Programmer Model 3200 units due to a potential risk of radio frequency interference causing unintended commands during in-clinic sessions.

    Product
    Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1144-2017·2017-02-15

    Physio-Control Recalls LIFEPAK 15 Defibrillators with Erroneous CO2 Readings

    Physio-Control is recalling LIFEPAK 15 Monitor/Defibrillators with End-Tidal CO2 options because the CO2 reading may intermittently display an incorrect value of XXX.

    Product
    LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1149-2017·2017-02-15

    Stryker Leibinger Recalls Surgical Drainage Accessories Due to Sterility Labeling Error

    Stryker Leibinger is recalling QUINTUBE Monitor Packs and SPG Bulb Drain Systems because non-sterile products were incorrectly labeled as sterile.

    Product
    QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to TLS Surgical Drainage System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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