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

35551–35575 of 40449

SevereFDA (Devices)·Z-1814-2014·2014-07-02
Nitinol HydroFinity Hydrophilic Guidewire Recalled for Outer Polymer Jacket Damage
Nitinol Devices and Components is recalling HydroFinity Hydrophilic guidewires because reports indicate the outer polymer jacket may be damaged during use.
Product
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 260 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1854-2014·2014-07-02
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-301 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 100, 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
SevereFDA (Devices)·Z-1925-2014·2014-07-02
Biomet Recalls Discovery Elbow Prosthesis Due to Surface Finish Defect
Biomet, Inc. is recalling one unit of a Discovery Elbow prosthesis because the surface finish differs from specifications, potentially causing pain requiring surgery.
Product
DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses are intended for primary and revision joint arthroplasty for use in cemented applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1874-2014·2014-07-02
Zynex IF 8000 Interferential Electrical Stimulation Device Recalled for Overheating
Zynex Medical is recalling 1,461 IF 8000 devices because a malfunction can cause them to stop working or overheat, posing a burn risk.
Product
IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. Designed for use in physical therapy, rehabilitation, and pain relief applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1871-2014·2014-07-02
Intuitive Surgical Recalls Da Vinci Xi Endoscope Accessories Due to Visual Tint
Intuitive Surgical is recalling 19 units of the IS4000 da Vinci Xi 0 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; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1859-2014·2014-07-02
NxStage Dialysate Sacks Recalled for Excess Aluminum Levels
NxStage Medical is recalling 2,711 cases of dialysate sacks because aluminum levels exceeded internal specifications.
Product
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-306 Lactate 45, Potassium 2, Sodium 140, Calcium 3, Magnesium 1, Chloride 101, 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
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
ModerateFDA (Devices)·Z-1926-2014·2014-07-02
Siemens Dimension LOCI Troponin I Calibrator Recalled for Result Shifts
Siemens is recalling Dimension LOCI Troponin I Calibrators because they may cause a 24% upward shift in test results.
Product
Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the cardiac troponin I (TNI) method for the Dimension clinical EXL integrated chemistry system with LOCI module.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1917-2014·2014-07-02
Anspach Custom Devices Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Anspach Custom Devices because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***REF SP-5001-00***20 degree Angle Driver (MA-D20) - Custom***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states

How to read this listing

Filters

35551–35575 of 40449