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

4676–4700 of 5111

SevereFDA (Devices)·Z-1000-2014·2014-02-26
Medtronic Recalls Select 3D and CAP Arterial Cannulae Due to Splitting
Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.
Product
Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized using Ethylene Oxide. Non-pyrogenic. The design and components of this product are specified b
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0827-2014·2014-02-19
Tandem T:slim Insulin Pump Cartridges Recalled for Leak Risk
Tandem Diabetes Care is recalling specific lots of T:slim insulin cartridges due to a risk of leaking, which could cause incorrect insulin delivery.
Product
T:slim Insulin Delivery System Insulin Infusion Pump
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0964-2014·2014-02-19
Stryker Accolade Broach Handle Recalled Due to Impaction Plate Fracture
Stryker Howmedica Osteonics Corp. is recalling 211 units of the Navigation Compatible Accolade Broach Handle because the impaction plate may dissociate or fracture from the main body.
Product
Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Made in USA non-sterile
Category
Medical Device
Distribution
5 states
SevereFDA (Devices)·Z-0908-2014·2014-02-12
Medtronic Mosaic Aortic Obturator Recalled for High Transvalvular Gradients
Medtronic is recalling Mosaic Aortic Obturators used with Mosaic Porcine Aortic Bioprostheses due to higher-than-expected transvalvular gradients after implant.
Product
Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0905-2014·2014-02-12
Medtronic Aquamantys3 Pump Generator Recalled for Electrical Safety Defect
Medtronic is recalling 242 Aquamantys3 Pump Generators because internal protection circuitry may fail, exposing patients to DC voltage during surgery.
Product
Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories) The Aquamantys3 System combines radio frequency (RF) energy and saline to reduce blood loss during and after surgical procedur
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0836-2014·2014-02-05
DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure
DeRoyal Industries is recalling 409 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.
Product
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0834-2014·2014-02-05
DeRoyal Aquarius Temperature Therapy Units Recalled for Temperature Control Failure
DeRoyal Industries is recalling 738 Aquarius Temperature Therapy units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.
Product
Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. Physical Therapy.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0862-2014·2014-02-05
Codman Certas Programmable Valves Recalled for Potential Malfunction
Codman & Shurtleff is recalling 369 Certas Programmable Valves used for hydrocephalus because they may not operate properly.
Product
Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories Product Code: 82-8805 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrosp
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0859-2014·2014-02-05
Codman Certas Programmable Valves Recalled for Potential Malfunction
Codman & Shurtleff is recalling 895 Certas Programmable Valves used for hydrocephalus because they may not operate properly.
Product
Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Product Code: 82-8801 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for th
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0838-2014·2014-02-05
DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure
DeRoyal Industries is recalling 2 units of the Aquarius Hot/Cold Therapy Combo Unit due to temperature monitoring failures and electric shock reports.
Product
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF T655NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0839-2014·2014-02-05
DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure
DeRoyal Industries is recalling 25 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.
Product
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS, REF T656NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0835-2014·2014-02-05
DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure
DeRoyal Industries is recalling 121 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.
Product
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0837-2014·2014-02-05
DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature and Shock Risks
DeRoyal Industries is recalling 48 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature and have caused electric shocks.
Product
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF T654NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0860-2014·2014-02-05
Codman Certas Programmable Valves Recalled for Potential Malfunction
Codman & Shurtleff, Inc. is recalling 431 Codman Certas Programmable Valves because they may not operate properly. These implantable devices are used to manage hydrocephalus.
Product
Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospi
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0780-2014·2014-01-29
Elekta XiO RTP System Recalled for Dose Calculation Error
Elekta is recalling 13 XiO RTP Systems because a software error prevents dose recalculation when proton spot beam fractions are changed.
Product
XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional rad
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-0812-2014·2014-01-29
Vital Signs Anesthesia Circuits Recalled Due to Occlusion Risk
Vital Signs Colorado Inc. is recalling anesthesia and ventilator circuits where a blue port cap may be attached, causing gas flow occlusion.
Product
Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer medical gases to a patient during anesthesia. The CPAP Circuit is intended to in
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0788-2014·2014-01-29
Codman TRUFILL n-BCA Liquid Embolic System Recalled for Incorrect Instructions
Codman & Shurtleff, Inc. is recalling 3,860 units of the TRUFILL n-BCA Liquid Embolic System due to incorrect instructions for use.
Product
TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriove
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0743-2014·2014-01-22
Atrium Medical Recalls Chest Drain Tubing Due to Leak or Disconnect Risk
Atrium Medical Corporation is recalling 1,944 units of Express Dry Seal ATS Chest Drains because the tubing may leak or disconnect.
Product
Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P. To evacuate air and/or fluid from the chest cavity or mediastinum.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0723-2014·2014-01-22
Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Issues
Boston Scientific is recalling TWISTER PLUS 26mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.
Product
TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN):M00561421. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica. Intended to be used in flexible endoscopes as a retrieval
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0737-2014·2014-01-22
Atrium Ocean Water Seal Chest Drain ATS Recall for Tubing Leaks
Atrium Medical Corporation is recalling 6,684 Ocean Water Seal Chest Drain ATS units because the chest drain tubing may leak or disconnect.
Product
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-300. To evacuate air and/or fluid from the chest cavity or mediastinum.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0714-2014·2014-01-22
Draeger Infinity Acute Care System Recall for Alarm Failure
Draeger Medical Systems is recalling 439 Infinity Acute Care System units because a high-grade SpO2 alarm may fail to activate after a medium-grade alarm is paused.
Product
Draeger Infinity Acute Care System Monitoring Solution
Category
Medical Device
Distribution
8 states
SevereFDA (Devices)·Z-0726-2014·2014-01-22
Anspach Carbide Cutting Burrs Recalled Due to Fracture During Use
The Anspach Effort, Inc. is recalling specific carbide cutting burrs because some fractured during use. The products are intended for cutting and shaping bone.
Product
Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball, 10 Flutes - part # QD8-4B-C-10F 5MM Carbide Fluted Ball, 10 Flutes - part #QD8-5B-C-10F 7MM Carbide Fluted Ball, 14 Flutes - part #QD8-7B-C-14F Anspach
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0650-2014·2014-01-15
Nova Hospital Blood Glucose Meters Recalled for Battery Swelling and Leakage
Nova Biomedical is recalling hospital blood glucose meters due to battery swelling and cell leakage. The recall covers approximately 200,000 units distributed nationwide.
Product
Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable Lithium Batteries Single: 46626; 4 Pack: 46827; 5 Pack: 50436. For Point-Of-Care usage in the quantitative determin
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0683-2014·2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling NanoClave Needlefree Connectors because a small percentage of devices may leak. The affected units were distributed worldwide.
Product
7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave¿ Clear, NThe ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula place
Category
Medical Device
Distribution
14 states
SevereFDA (Devices)·Z-0679-2014·2014-01-15
ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak. The affected units were distributed worldwide.
Product
8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item No. AC102 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient
Category
Medical Device
Distribution
14 states

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4676–4700 of 5111