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.

Agency

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

24951–24975 of 27686

HighFDA (Devices)·Z-1927-2014·2014-07-02
Siemens Healthcare Recalls ADVIA Acid/Base Reagent Kits Due to Metal Contamination
Siemens Healthcare is recalling ADVIA Acid/Base Reagent 1 and 2 Kits because trace metal contamination caused the acid bottles to swell.
Product
Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Number: 112219 SMN: 10310026 Intended Use: In vitro diagnostic use. Acid Regent is a component of the ADVIA Centaur and ADVIA Centaur XP…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1867-2014·2014-07-02
Siemens StreamLAB Analytical Workcell Recalled for Trip and Fall Hazard
Siemens is recalling 317 StreamLAB Analytical Workcells because protruding pins on the Input/Output Module have contributed to trip and fall incidents.
Product
Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and processing in the clinical laboratory.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1857-2014·2014-07-02
NxStage Dialysate Sacks Recalled for Excess Aluminum Levels
NxStage Medical is recalling dialysate sacks with concentrate due to aluminum levels exceeding internal product specifications.
Product
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-304 Lactate 45, Potassium 2, Sodium 140, Calcium 3,Magnesium 1, Chloride 101, Glucose (mg/dL) 100 Batch Size (liters) 60 The SAK is one of the disposables used with NxStage PureFlow SL…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1869-2014·2014-07-02
Elekta MOSAIQ Oncology System Recalled for Dose Calculation Error
Elekta, Inc. is recalling MOSAIQ oncology information system software because it fails to recalculate agent volume when users change the ordering dose.
Product
MOSAIQ MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used where ever radiotherapy and/or chemotherapy are prescribed.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1858-2014·2014-07-02
NxStage Dialysate Sacks Recalled for Excess Aluminum Levels
NxStage Medical is recalling dialysate sacks with concentrate due to aluminum levels exceeding internal product specifications.
Product
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-305 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1 Chloride 100, Glucose (mg/dL) 100 Batch Size (liters) 40
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1850-2014·2014-07-02
Steris Surgical Lighting Monitor Spring Arms Recalled for Welding Defect
Steris Corporation is recalling 68 vertical spring arms for surgical lighting systems because the welded seam may crack or break.
Product
Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. Model numbers YG19051 and YG19262.
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1870-2014·2014-07-02
Intuitive Surgical Recalls Da Vinci Xi Endoscope Accessories Due to Visual Tint
Intuitive Surgical is recalling 20 units of the IS4000 da Vinci Xi 30 Degree, 8mm Endoscope because an orange-yellow tint in the surgical view can make it difficult to differentiate between tissue.
Product
IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Intuitive Surgical Inc.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1831-2014·2014-07-02
Beckman Coulter Recalls UniCel DxH Analysis Systems for Optical Degradation
Beckman Coulter is recalling UniCel DxH800 and DxH600 systems because optical degradation may delay reporting of specific blood cell results.
Product
Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems for components that come in contact with blood samples.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1844-2014·2014-07-02
Puritan Bennett 840 Ventilator Recall for Display Loss
Nellcor Puritan Bennett is recalling 104 Puritan Bennett 840 Ventilators due to reports of loss of graphical user interface display information while the device continues to provide breath support.
Product
Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1872-2014·2014-07-02
Stryker Shaver Handpiece Sterilization Tray Recalled for Validation Deficiencies
Stryker Endoscopy is recalling 1,992 Shaver Handpiece Sterilization Trays because the provided STERRAD 100S sterilization parameters did not fully consider all worst-case scenarios during validation testing.
Product
Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1841-2014·2014-07-02
SeaSpine Recalls UCR 3mm Hex Large Axial Driver Due to Tip Deformation
SeaSpine Inc is recalling seven units of the UCR 3mm Hex, Large Axial Driver because the tip may twist or become rounded during use.
Product
Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying reduction heights provided with the Malibu", UCR, and NewPort" Systems. The Malibu", UCR, NewPort" Systems are intended to be used…
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1853-2014·2014-07-02
Nidek RT-5100 and RT-3100 Refractors Recalled for Potential Injury
Nidek Inc is recalling RT-5100 and RT-3100 refractors because the near point chart arm may lower spontaneously, posing a risk of patient injury.
Product
RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK CO., Ltd., Aichi, Japan. Instrument provides means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subject's eyes for purpose of…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1848-2014·2014-07-02
SteriGear Recalls Urinary Drain Bags Due to Valve Malfunction
SteriGear is recalling 110,560 urinary drain bags because the valve can close and create negative pressure, potentially blocking urine flow.
Product
SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-800-398-3259, SteriGear.com, Sterile, EO Urinary Drainage Collection Kit, for Indwelling Catheter. This device is intended to collect the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1829-2014·2014-07-02
Beckman Coulter Recalls UniCel DxH 600 and DxH 800 Analysis Systems
Beckman Coulter is recalling UniCel DxH 600 and DxH 800 systems because optical degradation may delay reporting of specific blood cell results.
Product
UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1849-2014·2014-07-02
Western VIPR Pressure Regulators Recalled for Cylinder Separation Risk
Western / Scott Fetzer Company is recalling Model RG3000 and RG4000 Series Valve Integrated Pressure Regulators (VIPR) because they may separate from aluminum cylinders.
Product
Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1873-2014·2014-07-02
JAS Diagnostics Recalls Glucose Hexokinase Reagent Lots for Performance Issues
JAS Diagnostics Inc. is recalling specific lots of Glucose Hexokinase Liquid Reagent because they do not perform according to specifications.
Product
Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-1828-2014·2014-07-02
Beckman Coulter Recalls UniCel DxH 800 and DxH 600 Analysis Systems
Beckman Coulter is recalling UniCel DxH 800 and DxH 600 systems because optical degradation may delay reporting of specific blood cell results.
Product
UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and B24802. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.
Category
Medical Device
Distribution
1 state
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

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24951–24975 of 27686