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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35626–35650 of 40449

  • ModerateFDA (Devices)·Z-1847-2014·2014-07-02

    Baxter Abacus 3.1 Pharmacy Calculator Software Field Correction

    Baxter is correcting a software error in Abacus 3.1 that may display protein levels 1,000 times lower than actual when using Clinimix 4.25110.

    Product
    Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1856-2014·2014-07-02

    NxStage Dialysate Sacks Recalled for Excess Aluminum Levels

    NxStage Medical is recalling dialysate sacks used with the PureFlow SL system because they contain aluminum levels exceeding internal specifications.

    Product
    NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-303 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 100m Chloride 100m, Glucose (mg/dL) 100 Batch Size (liters) 50 The SAK is one of the disposables used with NxStage PureFlow SL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1895-2014·2014-07-02

    Anspach Custom eMax 2 Plus Motor Recalled for Quality System Defects

    The Anspach Effort, Inc. is recalling nine Custom eMax 2 Plus Motors because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0035***Custom eMax 2 Plus Motor with microMax Disconnect Sleeve***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1846-2014·2014-07-02

    ProBeam Proton Therapy System Recalled for Treatment History Data Loss

    Varian Medical Systems is recalling ProBeam Proton Therapy Systems because the Treatment Control and Monitoring application may fail to send treatment history records to the ARIA database.

    Product
    ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body. where radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1860-2014·2014-07-02

    NxStage Dialysate Sacks Recalled for Excess Aluminum Levels

    NxStage Medical is recalling dialysate sacks used in home dialysis systems because aluminum levels exceeded internal specifications.

    Product
    NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-307 Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100 Batch Size (liters) 50 The SAK is one of the disposables used with NxStage PureFlow SL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1899-2014·2014-07-02

    Anspach eMax 2 Plus Hand Control Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling two eMax 2 Plus Hand Controls because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0043***Custom Device eMax 2 Plus Hand Control that will work with a Speed Reducer***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1842-2014·2014-07-02

    Zimmer Recalls VerSys Hip Stems Due to Material Inspection Failures

    Zimmer, Inc. is recalling 147 VerSys Hip System stems because supplier forgings failed routine material inspections.

    Product
    VerSys¿ Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1928-2014·2014-07-02

    Alere Triage BNP Calibrators Recalled Due to Mislabeling

    Alere San Diego is recalling BNP calibrators because a Level 5 bottle contains Level 4 material, causing calibration failures.

    Product
    Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 The Alere Triage BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1852-2014·2014-07-02

    Spacelabs Qube Compact Monitor Recalled for Network Connection Loss

    Spacelabs Healthcare is recalling Qube Compact Monitors due to a potential loss of network connection when switching to the Qube Docking Station without powering down.

    Product
    Spacelabs Healthcare Qube Compact Monitor, Model 91390. Intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces.
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-1865-2014·2014-07-02

    Philips Recalls Ingenia MRI Systems Due to Incorrect Nut Material

    Philips is recalling 24 Ingenia 1.5T MRI systems because some units shipped between December 2013 and March 2014 were supplied with incorrect M10 nuts instead of A4 stainless steel nuts.

    Product
    Ingenia 1.5T, magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1863-2014·2014-07-02

    Philips Recalls Ingenia 1.5T MRI Systems Due to Incorrect Hardware

    Philips Medical Systems is recalling 33 Ingenia 1.5T MRI systems because incorrect M10 nuts were installed on the rear cover set.

    Product
    Ingenia 1.5T R5, magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1894-2014·2014-07-02

    Anspach Custom Pneumatic Motor Devices Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling 16 custom pneumatic motor devices because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Custom Autolube III IRR Foot Pedal***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1877-2014·2014-07-02

    Anspach 8 mm Coarse Headless Screw Recall for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling 8 mm Coarse Headless Screws because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0022***8 mm Coarse Headless Screw with Driver***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1916-2014·2014-07-02

    Anspach Arthroscopic Suture Anchor Threaders Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling Anspach Custom Devices, specifically arthroscopic suture anchor threaders, because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1887-2014·2014-07-02

    Anspach eMax 2 Modified Hand Control Recalled for Quality System Non-Compliance

    The Anspach Effort, Inc. is recalling six eMax 2 Modified Hand Control units because they were not manufactured consistently with Quality System requirements.

    Product
    ANSPACH***REF 98-0016***eMax 2 Modified Hand Control***Rx Only*** This device is intended to be used with Anspach Systems
    Category
    Medical Device
    Distribution
    14 states
  • LowFDA (Devices)·Z-1930-2014·2014-07-02

    Microgenics Recalls MAS Omni Immune PRO Controls Due to Labeling Error

    Microgenics Corporation is recalling MAS Omni Immune PRO Controls because the package insert failed to reflect the removal of the constituent Inhibin A.

    Product
    MAS Omni Immune PRO Controls
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1929-2014·2014-07-02

    Microgenics Recalls MAS Omni Immune Controls Due to Labeling Error

    Microgenics Corporation is recalling MAS Omni Immune Controls because the package insert failed to reflect the removal of the constituent Inhibin A.

    Product
    MAS Omni Immune Controls
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1785-2014·2014-06-25

    Convatec Recalls Flexi-Seal Fecal Management System for Regulatory and Performance Issues

    Convatec Inc. is recalling the Flexi-Seal Fecal Management System because it lacks FDA 510(k) clearance and its Auto-Valve feature is not performing consistently.

    Product
    Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1798-2014·2014-06-25

    Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters

    Boston Scientific is recalling 968 IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.

    Product
    IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Large Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1837-2014·2014-06-25

    Biomet G7 Acetabular System Positioning Guide Rod Recalled for Fracture Risk

    Biomet is recalling G7 Acetabular System Positioning Guide Rods because they may fracture during surgery, potentially causing retained fragments or surgical delays.

    Product
    G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1827-2014·2014-06-25

    Philips MR Trolley Recall for Foot Clamping Hazard

    Philips is recalling Height Adjustable FlexTrak trolleys and Trolley Variable Height IRFs for Ingenia MR systems due to a risk of foot clamping.

    Product
    Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1794-2014·2014-06-25

    Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters

    Boston Scientific is recalling 968 IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.

    Product
    IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1809-2014·2014-06-25

    Nellcor Puritan Bennett PB840 Ventilator Display Component Recalled

    Nellcor Puritan Bennett Inc. is recalling Backlight Inverter Printed Circuit Boards for PB840 Ventilators due to a potential loss of the graphical user interface display.

    Product
    Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: The Backlight Inverter Printed Circuit Board (BLI PCBA) for the 9.4 Display part number 4-079056-00. The PB840 Ventilator System is intended to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1803-2014·2014-06-25

    Biomet Recalls EZPass Suture Passer Due to Wire Buckling

    Biomet, Inc. is recalling 102 EZPass Suture Passers because the nitinol wire may buckle and become kinked, making the instrument difficult to use.

    Product
    EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. Part numbers 904050, 904051, 904052, 904053, 904054, 904055, and 904056.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1810-2014·2014-06-25

    Walmart Recalls Fifteen Pairs of Safety Glasses for Thickness Defects

    Walmart is recalling 15 pairs of safety glasses that failed to meet required industrial lens thickness and lacked OSHA markings.

    Product
    Safety glasses made with "Rage" frames manufactured between February 20, 2014 and February 25, 2014. The color of the frames of the recalled glasses were either white or black. Safety Eye wear
    Category
    Consumer Product
    Distribution
    12 states