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 deaths or serious injuries are reported, 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.

Filters

Agency

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

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

4426–4450 of 5038

  • SevereFDA (Devices)·Z-0156-2015·2014-11-12

    Terumo Cardioplegia Delivery Set Recalled for Luer Connector Seal Defect

    Terumo is recalling specific Cardioplegia Delivery Sets because a defect in the luer connector can compromise the seal and introduce air into the tubing line.

    Product
    Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0168-2015·2014-11-12

    IBA Dosimetry Recalls COMPASS Software Due to Dose Calculation Errors

    Iba Dosimetry Gmbh is recalling COMPASS software version 3.1 because a defect may prevent detection of dose distribution errors, potentially leading to incorrect radiation doses during treatment.

    Product
    COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0142-2015·2014-11-05

    Mabis Recalls DMI Rollator Transport Chairs Due to Collapse Risk

    Briggs Medical Service Company is recalling 1,869 DMI Rollator Transport Chairs because they may collapse during use.

    Product
    DMI Duro-Med Industries Rollator Transport Chair; Wheel Size: 7 1/4"; Overall Width: 23 1/2"; Seat Height: 21 1/4"; Seat Size: 14" x 12 3/4"; Handle Height: 31" - 36"; Width Between Handles: 18"; Weight: 19 Lbs; Walking assistance device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0112-2015·2014-11-05

    FDA Recalls 324 Puritan Bennett 980 Ventilators Due to Software Issue

    The FDA is recalling 324 Puritan Bennett 980 ventilators because a software issue may cause the devices to become inoperative.

    Product
    Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-0086-2015·2014-10-29

    Siemens Mammomat Inspiration Mammography Systems Recalled for Safety Switch Defect

    Siemens is recalling three Mammomat Inspiration mammography systems because a safety switch defect may allow the needle positioning device to move during a biopsy.

    Product
    Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0089-2015·2014-10-29

    Codman EDS 3 Drainage System Recalled for Potential CSF Leakage

    Codman & Shurtleff is recalling EDS 3 Drainage Systems because tubing may leak or disconnect, risking improper fluid drainage or air introduction.

    Product
    Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0091-2015·2014-10-29

    Codman Lumbar Drainage Catheter Kit Recalled for Potential CSF Leakage

    Codman & Shurtleff is recalling Lumbar Drainage Catheter Kits because tubing may leak or disconnect, risking improper drainage or air entry.

    Product
    Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the inser
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0046-2015·2014-10-22

    Kendall Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs

    FDA recalls 133,930 pairs of Kendall defibrillation electrodes because they are not compatible with specific Philips AED models.

    Product
    Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number: 40000006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0043-2015·2014-10-22

    Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs

    FDA recalls 317,550 pairs of defibrillation electrodes because they are not compatible with Philips FR3 or FRx AEDs.

    Product
    Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0074-2015·2014-10-22

    Intuitive Surgical Recalls EndoWrist Stapler 45 Instruments

    Intuitive Surgical is recalling 1,034 EndoWrist Stapler 45 instruments because they may not be removable from tissue.

    Product
    EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si System. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0081-2015·2014-10-22

    Siemens Clinitek Status+ Power Supply Adapters Recalled for Electric Shock Risk

    Siemens Healthcare Diagnostics is recalling approximately 4,200 external power supply adapters for the Clinitek Status+ urine analyzer due to damage that can cause electric shock.

    Product
    External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0058-2015·2014-10-15

    Biomet Recalls Mamba Disposable Nitinol Needles Due to Breakage Risk

    Biomet is recalling 164 Mamba Disposable Nitinol Needles because high friction may cause the needles to break during use.

    Product
    Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0018-2015·2014-10-15

    Cardinal Health Prefilled Buffered 10% Formalin Recalled for Concentration Issues

    Richard-Allan Scientific Company is recalling Cardinal Health Prefilled Buffered 10% Formalin because the formalin concentration may be outside specifications.

    Product
    Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2695-2014·2014-10-01

    PDG Fuze Manual Tilt Wheelchairs Recalled for Axle Plate Detachment Risk

    PDG Product Design Group is recalling Fuze T50, T20, and T50 Jr manual tilt wheelchairs because a hex bolt head might shear, causing the axle plate to detach and the wheels to collapse.

    Product
    Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-2685-2014·2014-10-01

    Nanosphere Verigene Enteric Pathogens Test Recalled for Processing Errors

    Nanosphere is recalling 220 units of the Verigene Enteric Pathogens Nucleic Acid Test due to increased processing errors caused by Tip Holder Assemblies.

    Product
    The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence markers from liquid or soft stool preserved in Cary-Blair media, collected from indiv
    Category
    Medical Device
    Distribution
    25 states
  • SevereFDA (Devices)·Z-2707-2014·2014-10-01

    Spacelabs Patient Monitor Recall for Missing Audible Alarms in End Case Mode

    Spacelabs Healthcare is recalling 222 patient monitors because they may fail to provide audible alarms in End Case mode, a defect missed in a previous recall.

    Product
    Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2702-2014·2014-10-01

    Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leaks

    Vapotherm is recalling 387 Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.

    Product
    Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2622-2014·2014-10-01

    ICU Medical Recalls Stat 2 Flow Controllers Due to Flow Rate Issues

    ICU Medical is recalling specific IV administration sets because the Stat 2 flow controller may deliver a significantly higher flow rate than intended.

    Product
    98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2642-2014·2014-09-24

    EMG Technology Recalls Vac-Assist Suction Units Due to Occluded Ports

    EMG Technology is recalling 1,452 Vac-Assist Suction Units because the canister lids may have occluded ports, potentially preventing proper fluid removal.

    Product
    Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2608-2014·2014-09-17

    Wright Medical Recalls CLAW II Straight Plates Due to Incorrect Raw Material

    Wright Medical Technology is recalling 50 units of CLAW II Straight Plates because they were manufactured from an incorrect raw material.

    Product
    CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm, REF 40242025, 1 EACH, Rx ONLY, NON STERILE Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2627-2014·2014-09-17

    Stryker Recalls Aria Inserter Devices Due to Product Fracturing

    Stryker Spine is recalling 57 units of Aria Standard and Specialty Implant Inserters because of complaints that the instruments fractured.

    Product
    Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers implants that are interbody fusion devices intended for use as an aid in
    Category
    Medical Device
    Distribution
    24 states
  • SevereFDA (Devices)·Z-2626-2014·2014-09-17

    Stryker Recalls Aria Implant Inserters Due to Product Fracturing Complaints

    Stryker Spine is recalling 64 units of Aria Standard and Specialty Implant Inserters due to complaints of product fracturing. The devices are used for spinal fusion procedures.

    Product
    Stryker Aria Implant Inserter, REF 48758500, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal f
    Category
    Medical Device
    Distribution
    24 states
  • CriticalFDA (Devices)·Z-2500-2014·2014-09-10

    Customed Recalls Shoulder Arthroscopy Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 74 units of Shoulder Arthroscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Shoulder Arthroscopy Pack, code 900-2719, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (1) COBAN WRAP TAN 4 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DRESSING 1 X 8 XEROFORM PETROLAT (1 0) GAUZE SPONGES 4 X 4 16PL Y XRD (1) NEEDLE HYPODERMIC 18G X 1 (1) NEEDLE SPINAL ANESTH 18G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2302-2014·2014-09-10

    Customed Angiodrape Pack Recalled for Potential Packaging Integrity Issues

    Customed, Inc. is recalling 1,536 units of Angiodrape Packs due to potential packaging integrity issues that could compromise sterility and risk patient injury.

    Product
    Customed Angiodrape Pack convenience pack include multiple components: syringe 10cc and 30cc, gauze, denture cup, specimen container, band bag, glove, gown, needle hypodermic, absorbent towels, table cover, scalpel,cloth huck towel,iodine povidone,applicator sponge,towel clamp,
    Category
    Medical Device
    Distribution
    Distributed nationwide