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

4601–4625 of 5038

SevereFDA (Devices)·Z-1091-2014·2014-03-05
Instrumentarium Dental FOCUS 3.0 Intraoral X-ray Units Recalled for Mounting Flaw
Instrumentarium Dental is recalling FOCUS 3.0 intraoral x-ray units due to incomplete welding in the wall mount hardware, which could cause the unit to drift or fall.
Product
The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOCUS is connected to the Sigma USB terminal which is connected to a PC, which read
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1077-2014·2014-03-05
DePuy PFC SIGMA Knee Implant Recall Due to Microstructure Defects
DePuy Orthopaedics is recalling PFC SIGMA knee implants with anomalous microstructure that may decrease fatigue strength and cause fracture.
Product
PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-1102-2014·2014-03-05
Fresenius Optiflux F200NRe Dialyzers Recalled for Dialysate Port Leak
Fresenius Medical Care is recalling Optiflux F200NRe dialyzers because the dialysate port may leak during priming, posing a risk to patients.
Product
Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or chronic hemanalysis treatment.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1069-2014·2014-03-05
Terumo Recalls VirtuoSaph Plus Endoscopic Vessel Harvesting System
Terumo is recalling 26 units of the VirtuoSaph Plus Endoscopic Vessel Harvesting System due to potential sterility compromise.
Product
VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1105-2014·2014-03-05
Fresenius Recalls Optiflux B200 Flux Dialyzers Due to Port Leak Risk
Fresenius Medical Care is recalling 100,008 Optiflux B200 Flux Dialyzers because the dialysate port may leak during priming.
Product
Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemanalysis treatment.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1090-2014·2014-03-05
Philips HeartStart MRx Monitor/Defibrillator Recalled for ESD Component Damage
Philips is recalling HeartStart MRx Monitor/Defibrillators because a processor board component may be damaged by electrostatic discharge, disrupting ECG and SpO2 functionality.
Product
HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A, M3536A, M3536J, M3536MC The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained i
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1089-2014·2014-03-05
Orthofix Azure Anterior Cervical Plate System Recall for Fracture Risk
Orthofix is recalling Azure Anterior Cervical Plate Systems because the locking mechanism may fracture during or after implantation.
Product
Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only The Azure Anterior Cervical Plate System is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7 and is indicated for: A. D
Category
Medical Device
Distribution
Distributed nationwide
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-1059-2014·2014-02-26
Elekta Synergy XVI Radiation Therapy System Recalled for Table Position Error
Elekta is recalling Synergy XVI radiation therapy systems because a software error can cause the treatment table to move to an incorrect position during specific online registration procedures.
Product
Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. This is the sequence of events when this error occurs - (1) You do an online VolumeView acquisition and registration. (2) You accept t
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0999-2014·2014-02-26
Medtronic Recalls Select 3D and CAP Arterial Cannulae Due to Body Splitting
Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.
Product
Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae has clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips. The proximal end of
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0995-2014·2014-02-26
Medtronic Recalls Select 3D Arterial Cannulae Due to Body Splitting
Medtronic is recalling Select 3D Arterial Cannulae because the device body may split near the suture collar.
Product
Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) and 78720 (20 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae both have clear flexible, thin wall wi
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-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-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-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-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-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-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-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-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-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-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-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

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