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

23851–23875 of 27699

HighFDA (Devices)·Z-1053-2015·2015-02-11
CareFusion Recalls SmartSite Infusion Sets Due to Disconnection and Leakage
CareFusion is recalling 7,440 SmartSite Low Sorbing Infusion Sets due to disconnection and leakage issues.
Product
SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1013-2015·2015-02-04
Siemens Syngo RT Therapist Software Recall Due to Mistreatment Risk
Siemens is recalling Syngo RT Therapist software because a combination with CTVision may cause wrong offset calculations, leading to patient mistreatment.
Product
Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1022-2015·2015-02-04
Innokas Medical VC150 Vital Signs Monitor Recalled for Alarm Failure
Innokas Medical is recalling 20 VC150 Vital Signs Monitors because they may fail to issue visual and audible alarms when SpO2 or RRa values violate limits during mode switching.
Product
VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1019-2015·2015-02-04
Sunrise Medical Recalls Three Zippie Zone Pediatric Wheelchairs Due to Handle Defect
Sunrise Medical is recalling three Zippie Zone Pediatric Rigid Wheelchairs because the height-adjustable handle may dislodge due to failing locking mechanisms.
Product
Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1011-2015·2015-02-04
Philips BrightView MRI Systems Recalled for Unintended Movement
Philips is recalling 1,064 BrightView MRI systems worldwide due to software issues causing unintended detector and gantry movement.
Product
BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1014-2015·2015-02-04
Clinical Innovations Recalls Ebb Complete Tamponade System Due to Balloon Leak Risk
Clinical Innovations, LLC is recalling 827 units of the Ebb Complete Tamponade System because of a potential for balloon leaks in lots manufactured since August 2014.
Product
Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1016-2015·2015-02-04
Mobius Airo Mobile Intraoperative CT System Recalled for Data Transfer Errors
Mobius Imaging is recalling 21 Airo Mobile Intraoperative CT systems because a software error may cause incorrect or missing navigation data to transfer to the Brainlab Curve system.
Product
Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-1031-2015·2015-02-04
Baxter HomeChoice Peritoneal Dialysis Cycler Recalled for Keypad Malfunction
Baxter Healthcare is recalling HomeChoice and HomeChoice Pro automated peritoneal dialysis cyclers because the keypad buttons may activate without being pressed.
Product
HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.
Category
Medical Device
Distribution
36 states
HighFDA (Devices)·Z-1020-2015·2015-02-04
Sunrise Medical Recalls Six Quickie Q7 Adult Rigid Wheelchairs
Sunrise Medical is recalling six Quickie Q7 Adult Rigid Wheelchairs because the height-adjustable handle may dislodge due to failing locking mechanisms.
Product
Quickie Q7 Adult Rigid Wheelchair Model EIR4.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0996-2015·2015-01-28
TransMotion Medical Recalls Powered Stretcher Chairs Due to Involuntary Movement
TransMotion Medical Inc is recalling 1,127 powered stretcher chairs used in surgeries because the controllers may cause the chairs to move involuntarily.
Product
Powered stretcher chair used during facial and eye surgeries. One chair per package.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0993-2015·2015-01-28
Maquet Tegris System Recalled Due to Software Error in Operating Table Commands
Maquet Medical Systems USA is recalling six units of the Tegris System because a software error switches leg movement commands for the Magnus OR table.
Product
TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as the central operating unit in an operating room. The integration system has two main functions: Recording and distribution of images and videos and interaction…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0994-2015·2015-01-28
Siemens Radiographic Systems Recalled for Potential Image Flipping Errors
Siemens is recalling 11 Ysio Max, Luminos dRF Max, and Agile Max systems because software errors may cause images to flip, leading to incorrect labels and potential misdiagnosis.
Product
Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including…
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1000-2015·2015-01-28
BD Biosciences Recalls Contaminated CD8 PE In Vitro Diagnostic Reagent
BD Biosciences is recalling one lot of CD8 PE reagent contaminated with CD4 FITC, which may cause incorrect patient data.
Product
CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0998-2015·2015-01-28
Cordis POWERFLEX PRO PTA Dilatation Catheter Recall for Unsterilized Unit
Cordis Corporation is recalling one unsterilized unit of the POWERFLEX PRO PTA Dilatation Catheter from a demonstration lot left at a hospital.
Product
Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0995-2015·2015-01-28
Ferno Model 35X Stretchers Recalled Due to Loose Wheel Assemblies
Ferno-Washington Inc is recalling 46 Model 35X stretchers because wheel castor assemblies may loosen, posing a risk of injury.
Product
Ferno Model 35X PROFlexx Stretchers, one unit per package
Category
Medical Device
Distribution
8 states
SevereFDA (Devices)·Z-0963-2015·2015-01-21
Philips HeartStart MRx Monitor/Defibrillator Recalled for Malfunction Risk
Philips is recalling HeartStart MRx monitor/defibrillators because the device may malfunction, potentially delaying or disabling therapy or delivering it inadvertently.
Product
HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0916-2015·2015-01-21
Boston Scientific Recalls Lotus TAVR Valve Prosthesis Due to Unlocking Risk
Boston Scientific is recalling Lotus TAVR 25mm valve prostheses because the valve may unlock during release, potentially requiring additional procedures or surgery.
Product
Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV250, Catalog Number LTV25; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0980-2015·2015-01-21
Siemens Linear Accelerators Recalled for Unauthorized Component Safety Risks
Siemens Medical Solutions is recalling 320 linear accelerators because unauthorized third-party components may cause patient or operator injury and dose calculation errors.
Product
Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0951-2015·2015-01-21
FDA Recalls Unapproved Color Contact Lenses Contaminated with Bacteria
Intertrade Imports Inc. is recalling I Color Complete contact lenses because FDA testing found bacteria and the product is not sterile.
Product
Labeled in part: I Color Complete / Crazy Lens, blister packing, 14.5mm, (Additional colors include: #003 White out, #005 Yellow out, #020 Red out, #014 Black out, #070 Manson, #136 Lava, #009 Yellow cat, #073 Red cat, #050 White cat, #032 Soccer ball, #077 Spiral, #071…
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0915-2015·2015-01-21
Boston Scientific Recalls Lotus TAVR 23mm Transcatheter Aortic Valve Prosthesis
Boston Scientific is recalling 278 units of the Lotus TAVR 23mm valve because the device may unlock during release, potentially causing the valve to embolize.
Product
Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV230, Catalog Number LTV23; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0917-2015·2015-01-21
Boston Scientific Recalls Lotus TAVR 27mm Transcatheter Aortic Valve Prosthesis
Boston Scientific is recalling 278 units of the Lotus TAVR 27mm valve because the device may unlock during release, potentially causing the valve to embolize.
Product
Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV270, Catalog Number LTV27; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0953-2015·2015-01-21
DePuy ATTUNE INTUITION Impaction Handle Recalled for Fracture Risk
DePuy Orthopaedics is recalling ATTUNE INTUITION Impaction Handles because the lever can fracture during knee surgery, potentially leaving device pieces in the patient.
Product
The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with several related ATTUNE instruments: keel punch, tibial tower, evaluation bullet, fixed bearing tibial impactor, rotating platform tibial…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0954-2015·2015-01-21
GE Healthcare Proteus XR/a Wall Stand Cable Breakage Recall
GE Healthcare is recalling Proteus XR/a X-ray systems with wall stands due to potential breakage of steel support cables. No injuries have been reported.
Product
GE Healthcare, Proteus XR/a with wall stand model number 600-0301.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0956-2015·2015-01-21
Brainlab iPlan RT Dose Software Recalled for Potential Positioning Errors
Brainlab AG is recalling iPlan RT Dose software because it may produce incorrect patient positioning when using multiple CT image data sets.
Product
iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
Category
Medical Device
Distribution
45 states
HighFDA (Devices)·Z-0948-2015·2015-01-21
Abbott m2000sp Automated Sample Preparation System Recalled for X-Drive Failure
Abbott Molecular is recalling 176 m2000sp automated sample preparation systems because the x-drive assembly may fail prematurely, potentially causing the manipulator arm to contact objects or pipet improperly.
Product
The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.
Category
Medical Device
Distribution
12 states

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23851–23875 of 27699