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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

4051–4075 of 5111

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-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-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-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-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-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-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-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-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-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-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
SevereFDA (Devices)·Z-0689-2016·2016-02-03
Cook Medical Recalls Zilver 518RX Vascular Stent Delivery Systems
Cook Medical is recalling 753 Zilver 518RX Vascular Stent delivery systems because a manufacturing defect may cause the catheter joint to separate during use.
Product
Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0660-2016·2016-01-27
St. Jude Medical Recalls Optisure Dual Coil Defibrillation Leads
St. Jude Medical is recalling Optisure Dual Coil Defibrillation Leads due to potential insulation cuts in the SVC shock coil.
Product
Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0677-2016·2016-01-27
GE Aespire Anesthesia Systems Recalled for Potential Barotrauma Risk
GE Medical Systems is recalling Aespire 7900 and Aespire View anesthesia systems because a stuck valve could cause excessive pressure and barotrauma.
Product
GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0680-2016·2016-01-27
GE Aisys Anesthesia System Recalled for Potential Barotrauma Risk
GE Medical Systems is recalling 13 Aisys Anesthesia Systems because a stuck valve could cause excessive pressure in the patient breathing circuit, potentially resulting in barotrauma.
Product
GE Healthcare, Aisys, 1011-9000-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventila
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0672-2016·2016-01-27
MWT Materials Recalls Accusorb MRI Shielding Blankets Due to Overheating Risk
MWT Materials, Inc. is recalling Accusorb MRI MAC7010 radio frequency shielding blankets and body-part covers because they may overheat when not used correctly, posing a risk of patient injury.
Product
Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0671-2016·2016-01-27
MWT Materials Recalls Accusorb MRI Leg Wrap Blankets Due to Overheating Risk
MWT Materials, Inc. is recalling 47 units of Accusorb MRI Leg Wrap Blankets because they may overheat when not used correctly, posing a risk of patient injury.
Product
Accusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0663-2016·2016-01-27
MWT Materials Recalls Accusorb MRI Blankets Due to Overheating Risk
MWT Materials, Inc. is recalling 49 Accusorb MRI blankets because they may overheat and lead to patient injury when not used correctly.
Product
Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0665-2016·2016-01-27
MWT Materials Recalls Accusorb MRI Radio Frequency Shielding Products
MWT Materials, Inc. is recalling Accusorb MRI radio frequency shielding blankets and body-part covers because they may overheat and lead to patient injury when not used correctly.
Product
Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0641-2016·2016-01-20
Ortho-Clinical VITROS 5600 Chemistry System Software Recall
Ortho-Clinical Diagnostics is recalling VITROS 5600 Chemistry Systems due to a software anomaly that may cause erroneous test results without user notification.
Product
VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0478-2016·2016-01-13
Stryker Fuhrman Pleural Drainage Set Recalled for Breakage During Insertion
Stryker is recalling 34 Fuhrman Pleural/Pneumopericardial Drainage Sets because they broke off in the pleural cavity during patient insertion.
Product
The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access needle, dilator, and wire guide. The set also includes a multipurpose tubing adapter, and three-way stopcock.
Category
Medical Device
Distribution
8 states
SevereFDA (Devices)·Z-0588-2016·2016-01-13
Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter Recall for Handle Separation
Boston Scientific is recalling ACUITY Pro Coronary Sinus Guide Catheters due to a potential for the proximal handle to separate from the shaft.
Product
Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, and 8119. The ACUITY Pro Lead Delivery System is designed for venous use to aid in the selective placement of ca
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0569-2016·2016-01-06
BD Vacutainer PLUS K2EDTA Tubes Recalled for Insufficient Additive
Becton Dickinson is recalling specific lots of BD Vacutainer PLUS K2EDTA tubes because they may contain insufficient EDTA additive, which can lead to erroneous platelet results.
Product
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made in USA BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing
Category
Medical Device
Distribution
Distributed nationwide

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4051–4075 of 5111