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

33626–33650 of 40325

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
HighFDA (Devices)·Z-0959-2015·2015-01-21
Sun Nuclear IC Profiler-MR Recalled for Pinch Hazard
Sun Nuclear Corporation is recalling six IC Profiler-MR Model 1123 units due to a potential pinch hazard to users performing quality assurance in MRI environments.
Product
IC PROFILER-MR - Model 1123. A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0971-2015·2015-01-21
Siemens SOMATOM Force CT Scanner Recalled for Imaging Artifacts
Siemens Medical Solutions is recalling seven SOMATOM Force CT scanners because artifacts were found in acquired imaging.
Product
SOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0957-2015·2015-01-21
Brainlab iPlan RT Software Recalled for Potential Incorrect Patient Positioning
Brainlab AG is recalling iPlan RT radiation treatment planning software due to a risk of incorrect patient positioning when using multiple localized CT image data sets.
Product
iPlan RT is a 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-0974-2015·2015-01-21
Becton Dickinson Recalls Trypticase Soy Agar and MacConkey II Agar Plates
Becton Dickinson is recalling specific lots of Trypticase Soy Agar and MacConkey II Agar plates due to low-level Listeria monocytogenes contamination.
Product
TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0972-2015·2015-01-21
Siemens Artis Q Ceiling Systems Recalled for Cable Wear Risk
Siemens is recalling 50 Artis Q and Artis Q.zen ceiling systems because suboptimal cable routing may cause wear, leading to limited functionality or system failure.
Product
Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: The Artis family is dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0950-2015·2015-01-21
FDA Recalls Unapproved Color Contact Lenses Contaminated with Bacteria
Intertrade Imports Inc. is recalling I Color Complete color contact lenses because FDA testing found Bacillus Cereus and Bacillus Lentus. The lenses are also unapproved medical devices.
Product
Labeled in part: I Color Complete / Color Lens, blister packing, 14.5mm. (Additional colors include: 1) Illusion style, Chestnut Brown, Violet and others and 2) 2 Tone style: like Misty Blue among others)Eye contact lens Product Usage - Eye contact lens
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0977-2015·2015-01-21
SpineFrontier Recalls Inline Persuader Pedicle Screw System Due to Handle Crack
SpineFrontier, Inc. is recalling four Inline Persuader PedFuse Pedicle Screw Systems because a crack may develop in the handle, potentially progressing with continued use.
Product
lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0949-2015·2015-01-21
St. Jude Medical Merlin@home Transmitter Software Reset Recall
St. Jude Medical is recalling Merlin@home RF Remote Monitoring Transmitters because a software reset may cause backup operation in implanted cardiac devices.
Product
Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0973-2015·2015-01-21
Synthes Malleable C-Retractor Recalled Due to Potential Spring Corrosion
Synthes, Inc. is recalling Malleable C-Retractors because the internal spring may corrode or fail, potentially transferring particles to patients and causing adverse tissue reactions or infection.
Product
Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation. Used in the following systems: the Basic Trocar System, Universal Trocar System, Craniofacial Modular Fixation System, Craniofacial (CMF)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0958-2015·2015-01-21
Invivo Recalls Philips Expression MR200 MRI Patient Monitoring Systems
Invivo Corporation is recalling 20 Philips Expression MR200 MRI Patient Monitoring Systems due to capacitor shorts that may cause electrical shock or loss of monitoring.
Product
Philips Expression MR200 MRI Patient Monitoring System.
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-0987-2015·2015-01-21
Siemens ADVIA Chemistry XPT Software Recall for Result Overwrite Risk
Siemens is recalling 7 ADVIA Chemistry XPT systems in Washington due to a software defect that may cause critical results to be overwritten.
Product
ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0979-2015·2015-01-21
Philips CT Systems Recalled for Improper Vertical Motor Assembly
Philips is recalling Brilliance and Ingenuity CT systems because improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion.
Product
Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0966-2015·2015-01-21
GE Healthcare Recalls Discovery IGS 730 and 740 X-ray Systems
GE Healthcare is recalling 24 Discovery IGS 730 and 740 angiographic X-ray systems due to a user interface issue that may cause unintentional system motion or rotation.
Product
GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular & non vascular diagnostic and interventional…
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0952-2015·2015-01-21
Medtronic Spinal Surgical Instrument Recall Due to Component Sizing Issue
Medtronic is recalling 24 units of the POWEREASE Set Screw Breakoff Instrument because oversized retaining tabs may prevent proper mating with the set screw.
Product
POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0976-2015·2015-01-21
Becton Dickinson Recalls Columbia Agar with 5% Sheep Blood Due to Listeria
Becton Dickinson & Co. is recalling Columbia Agar with 5% Sheep Blood due to low-level Listeria monocytogenes contamination. The product is a non-sterile culture medium distributed worldwide.
Product
Columbia Agar with 5% Sheep Blood Columbia Agar with 5% Sheep Blood is a general purpose culture medium used for the growth and recovery of fastidious microbial species.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0975-2015·2015-01-21
Becton Dickinson Recalls CDC Anaerobe Agar Due to Listeria Contamination
Becton Dickinson is recalling CDC Anaerobe 5% Sheep Blood Agar due to low-level Listeria monocytogenes contamination. The affected non-sterile media were distributed worldwide.
Product
CDC Anaerobe 5% Sheep Blood Agar CDC Anaerobe 5% Sheep Blood Agar is an enriched, nonselective culture medium particularly useful or the isolation and cultivation of obligate anaerobes from clinical specimens. It supports the growth of a wide variety of obligately anaerobic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0960-2015·2015-01-21
Siemens Symbia CT Systems Recalled for Internal Component Damage
Siemens Medical Solutions is recalling 295 Symbia T and T2 CT systems because a component may come loose and damage the equipment.
Product
Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0978-2015·2015-01-21
Biomet Timberline Anchored Lateral Variable Retractable Sleeves Recalled for Undersized Diameter
Biomet Spine is recalling 12 units of Timberline Anchored Lateral Variable Retractable Sleeves because the inner diameter is undersized, causing interference fit issues.
Product
Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0947-2015·2015-01-21
Phadia 1000 Instrument Recalled for Rack Sequencing Error
Phadia US Inc is recalling 146 Phadia 1000 instruments due to a software error that may cause sample ID and test result mismatches.
Product
Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software…
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

33626–33650 of 40325