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.

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3976–4000 of 5038

  • SevereFDA (Devices)·Z-1024-2016·2016-03-09

    Philips SENSE Body Coil 1.5T Recalled for Potential Patient Burns

    Philips is recalling 5,672 SENSE Body Coil 1.5T units because improper cable placement can cause patient burns during MRI scans.

    Product
    SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0799-2016·2016-03-02

    Cook Inc. Recalls Single Lumen Central Venous Catheter Sets

    Cook Inc. is recalling 1,341 single-lumen central venous catheter sets and trays due to a manufacturing defect that may cause catheter tip fracture or separation.

    Product
    Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0975-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem Mediem Medical Devices Inc is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number M00548430 (XMD P/N 70-0050-A14) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The Endo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0800-2016·2016-03-02

    Cook Inc. Recalls Single Lumen Pressure Monitoring Sets Due to Tip Fracture

    Cook Inc. is recalling 2,280 single-lumen pressure monitoring sets and trays because a manufacturing defect may cause catheter tips to fracture or separate.

    Product
    Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0866-2016·2016-03-02

    GSI Group Recalls PRN 50-M+ Paper Chart Recorders for Fire Risk

    GSI Group Inc. is recalling 2,257 PRN 50-M+ Paper Chart Recorders due to a risk of fire or electrical shock.

    Product
    PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. Thi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0981-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem Mediem Medical Devices Inc is recalling 39 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548320 (XMD P/N 70-0050-B12) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0798-2016·2016-03-02

    Cook Inc. Recalls Shuttle Select Slip-Cath Catheters Due to Tip Splits

    Cook Inc. is recalling 9,519 Shuttle Select Slip-Cath Catheters worldwide due to reports of catheter tip splits and separation, which can cause loss of function or complications.

    Product
    Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0827-2016·2016-03-02

    Draeger Medical Recalls Evita and Babylog Ventilators Due to Battery Defect

    Draeger Medical is recalling Evita Infinity V500 and Babylog Infinity VN500 ventilators because the optional PS500 power supply unit batteries may discharge prematurely despite showing adequate charge.

    Product
    Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0801-2016·2016-03-02

    Cook Inc. Recalls Femoral Artery Pressure Monitoring Catheters Due to Tip Fracture Risk

    Cook Inc. is recalling specific femoral artery pressure monitoring catheter sets and trays because a manufacturing defect may cause the catheter tip to fracture or separate.

    Product
    Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0992-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 126 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00549420 (XMD P/N 70-0050-C22) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0921-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 326 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548350 (XMD P/N 70-0050-214) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0935-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 189 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548530 (XMD P/N 70-0050-416) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0930-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage

    Xeridiem is recalling 34 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents when disconnected.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548840 (XMD P/N 70-0050-320) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0805-2016·2016-02-24

    Varian Eclipse Treatment Planning System Recall for Dose Calculation Error

    Varian Medical Systems is recalling Eclipse Treatment Planning System versions 11, 13.0, 13.5, and 13.6 due to a dose calculation error that may result in unintended radiation exposure.

    Product
    Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan exter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0819-2016·2016-02-24

    Medtronic Recalls Endo GIA Ultra Universal Short Stapler Handles

    Medtronic is recalling 364,768 Endo GIA Ultra Universal Short Stapler Handles because they may fail to fire or partially fire, and the articulating lever may disengage during use.

    Product
    Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHORT Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0821-2016·2016-02-24

    Medtronic Recalls Endo GIA Ultra Universal 12 mm XL Stapler Handles

    Medtronic is recalling 327,797 Endo GIA Ultra Universal 12 mm XL Stapler Handles worldwide because the staplers may fail to fire or the articulating lever may disengage during surgery.

    Product
    Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resecti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0820-2016·2016-02-24

    Medtronic Recalls Endo GIA Ultra Universal Stapler Handles Due to Firing Defects

    Medtronic is recalling 1,102,166 Endo GIA Ultra Universal Standard Stapler Handles worldwide because they may fail to fire or partially fire during surgery.

    Product
    Covidien Endo GIA Ultra Universal Standard Stapler Handle Ref: EGIAUSTND Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resec
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0822-2016·2016-02-24

    Medtronic Recalls Endo GIA Ultra Universal Stapler Handles in Best Practice Kits

    Medtronic is recalling 2,711 Best Practice Kits containing specific Endo GIA Ultra Universal Stapler Handles due to reports of staplers failing to fire or partially firing, and articulating levers disengaging during use.

    Product
    Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler Handles Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0793-2016·2016-02-17

    Smith & Nephew BEAVER Blade 4.0mm Recalled for Fracture Risk

    Smith & Nephew is recalling BEAVER Blade 4.0mm orthopedic instruments because they may fracture during hip arthroscopy procedures.

    Product
    Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument used in hip arthroscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0760-2016·2016-02-17

    C.R. Bard Recalls Arctic Sun 5000 and 2000 Temperature Monitors

    C.R. Bard is recalling Arctic Sun 5000 and 2000 devices because a simulator key could be connected to the patient cable, resulting in improper temperature therapy.

    Product
    Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0767-2016·2016-02-17

    Mevion S250 Radiation Therapy System Recalled for Positioning Belt Slippage

    Mevion Medical Systems is recalling four MEVION S250 Radiation Therapy Systems because the treatment table positioning belt can slip, causing patient setup deviations.

    Product
    MEVION S250 Radiation therapy system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0765-2016·2016-02-17

    Philips Allura Xper FD OR Table Recalled for C-Arc Movement Issue

    Philips is recalling two Allura Xper FD OR Tables because the C-arc may continue moving after stopping due to improper adjustment.

    Product
    Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0692-2016·2016-02-10

    Draeger Oxylog 3000 Ventilators Recalled for Software Error

    Draeger Medical is recalling Oxylog 3000 and Oxylog 3000 Plus ventilators because a software error can stop ventilation and trigger alarms.

    Product
    Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. Volume controlled and pressure-controlled emergency and transport ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0745-2016·2016-02-10

    Philips Proton Therapy Planning Software Recalled for Dose Calculation Errors

    Philips Medical Systems is recalling DS/US Proton Feature software due to a defect that may cause incorrect dose calculations in radiation therapy planning.

    Product
    DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0691-2016·2016-02-10

    Draeger Oxylog 2000 Plus Ventilator Recalled for Malfunction

    Draeger Medical is recalling Oxylog 2000 Plus ventilators because a software error can stop ventilation and trigger alarms.

    Product
    Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventilator with pressure support.
    Category
    Medical Device
    Distribution
    Distributed nationwide