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

33776–33800 of 40325

ModerateFDA (Devices)·Z-0834-2015·2014-12-31
Intuitive Surgical Recalls Fluorescence Imaging Procedure Kits for Missing Storage Info
Intuitive Surgical is recalling Fluorescence Imaging Procedure Kits because storage conditions for indocyanine green are missing from the packaging.
Product
Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Si 3000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0835-2015·2014-12-31
Intuitive Surgical Recalls Fluorescence Imaging Procedure Kits for Missing Storage Info
Intuitive Surgical is recalling Fluorescence Imaging Procedure Kits because storage conditions for indocyanine green are missing from the packaging.
Product
Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Xi 4000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0833-2015·2014-12-31
GE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Loss Risk
GE Healthcare is recalling Centricity Enterprise Archive software versions 4.0.x due to a potential data loss issue associated with HL-7 updates.
Product
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices (e..g. modalities, workstations) Communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0860-2015·2014-12-31
Siemens ADVIA Centaur XP Immunoassay System Recalled for Tubing Crack Risk
Siemens Healthcare Diagnostics is recalling 10,515 ADVIA Centaur XP Immunoassay Systems because a slight crack may occur in the tubing at the reservoir connector assembly due to mechanical stress.
Product
ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0845-2015·2014-12-31
Advanced Sterilization Products Recalls STERRAD System Cassettes Due to Leak Indicator Defect
Advanced Sterilization Products is recalling STERRAD System cassettes because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.
Product
STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0844-2015·2014-12-31
Advanced Sterilization Products Recalls STERRAD 200 Cassettes Due to Leak Indicator Defect
Advanced Sterilization Products is recalling STERRAD 200 cassettes because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.
Product
STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0846-2015·2014-12-31
Advanced Sterilization Products Recalls STERRAD 100NX Cassettes Due to Leak Indicator Defect
Advanced Sterilization Products is recalling STERRAD 100NX cassettes because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.
Product
STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-0850-2015·2014-12-31
Illumina MiSeqDx Cystic Fibrosis Assay Recalled for Software Limitation
Illumina is recalling 19 units of the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay due to a confirmed software limitation in version 2.2.31.
Product
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
Category
Medical Device
Distribution
2 states
LowFDA (Devices)·Z-0858-2015·2014-12-31
Cyberonics VNS Therapy Generator Recalled for Incorrect Serial Number Labeling
Cyberonics is recalling one VNS Therapy AspireHC Model 105 Generator distributed in Pennsylvania due to an incorrect serial number on the device label.
Product
Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. Indicated for use as an adjunctive…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0824-2015·2014-12-24
Zimmer Manufacturing Recalls Self-Tapping Bone Screws Due to Fracture Risk
Zimmer Manufacturing B.V. is recalling 6,377 self-tapping bone screws used in hip surgery due to fractures caused by specific tool marks.
Product
Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-holed shells allow for the use of screws to provide additional fixation and security, particularly in those case where acetabular bone stock…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0828-2015·2014-12-24
Mako Surgical Recalls RESTORIS PST Straight Shell Impactors
Mako Surgical Corporation is recalling 404 RESTORIS PST Straight Shell Impactors because they may be damaged during surgery.
Product
RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0816-2015·2014-12-24
Philips EPIQ 5 Ultrasound System Recalled for Incorrect Ejection Fraction Calculations
Philips is recalling EPIQ 5 Ultrasound Systems because specific software plug-ins may calculate incorrect ejection fractions, potentially leading to misdiagnosis or delayed therapy.
Product
EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and Part Number: 989605408541 Diagnostic Ultrasound Imaging.
Category
Medical Device
Distribution
32 states
HighFDA (Devices)·Z-0818-2015·2014-12-24
Philips Q-Station Software Recalled for Potential Incorrect Cardiac Measurements
Philips is recalling Q-Station 3.0 software because automated cardiac measurements may be inaccurate, potentially leading to misdiagnosis or incorrect therapy.
Product
Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected. Model: Q-Station, Catalog number: 795088, and Part Number: 989605382391. Intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams.
Category
Medical Device
Distribution
32 states
HighFDA (Devices)·Z-0817-2015·2014-12-24
Philips EPIQ 7 Ultrasound Systems Recalled for Incorrect Ejection Fraction Calculations
Philips is recalling EPIQ 7 ultrasound systems because specific software plug-ins may calculate incorrect ejection fractions, potentially leading to misdiagnosis or incorrect therapy.
Product
EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 7G, EPIC 7C, EPIQ 7W; Catalog Number: 795200 / 795201 and Part Number: 989605386721. Diagnostic Ultrasound Imaging.
Category
Medical Device
Distribution
32 states
HighFDA (Devices)·Z-0808-2015·2014-12-24
Siemens Biograph mCT Flow 40-4R Recalled for Display Freeze Risk
Siemens Medical Solutions is recalling one Biograph mCT Flow 40-4R scanner due to a potential display freeze during CT interventional procedures.
Product
Biograph mCT Flow 40-4R, System Material Number 10529159. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0451-2015·2014-12-24
GE Healthcare Recalls Innova IGS 540 Imaging Systems Due to Motion Loss
GE Healthcare is recalling 10 Innova IGS 540 systems because they may lose real-time imaging or gantry motion due to electromagnetic sensitivity.
Product
Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0754-2015·2014-12-24
Stryker Johann Forceps Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling Johann Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM X 45CM INSERT, JOHANN FORCEPS, P/N 0250080764 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0526-2015·2014-12-24
Varian On-Board Imager X-ray Generators Recalled for Missing Ground Wire
Varian Medical Systems is recalling 32 On-Board Imager systems because the X-ray generators are missing a required ground wire.
Product
Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial land¿¿ marks.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0453-2015·2014-12-24
GE Healthcare Recalls Innova 4100IQ Fluoroscopic Imaging Systems
GE Healthcare is recalling six Innova 4100IQ fluoroscopic systems due to a defect that may cause loss of real-time imaging or gantry motion.
Product
Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and optionally, rotational imaging procedure.
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0829-2015·2014-12-24
Mako Surgical Recalls RESTORIS PST Acetabular Straight Shell Impactors
Mako Surgical Corporation is recalling 404 RESTORIS PST Acetabular Straight Shell Impactors due to the potential for intraoperative damage.
Product
RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0807-2015·2014-12-24
Siemens Biograph mCT Flow Edge-4R Recalled for Display Freeze Risk
Siemens Medical Solutions USA Inc. is recalling four Biograph mCT Flow Edge-4R scanners due to a potential system display freeze during CT interventional procedures.
Product
Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0825-2015·2014-12-24
DePuy Ceramic Femoral Head Recalled for Fit Issues in Hip Surgery
DePuy Orthopaedics is recalling 19 units of BIOLOX delta TS Ceramic Femoral Heads due to reports that the device did not fit as expected during hip surgery.
Product
Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0815-2015·2014-12-24
Philips QLAB Software Recall for Incorrect Ejection Fraction Calculations
Philips Ultrasound is recalling QLAB software versions 10.0, 10.1, and 10.1.1 because automated quantification features may report inaccurate cardiac measurements, potentially leading to misdiagnosis.
Product
Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. *********************************************************************************** Devices identified in the Field…
Category
Medical Device
Distribution
32 states
HighFDA (Devices)·Z-0236-2015·2014-12-24
Philips Brilliance iCT Computed Tomography System Software Defect Recall
Philips Medical Systems is recalling 16 Brilliance iCT Computed Tomography X-Ray Systems due to a software defect that may prevent scans from terminating at the intended location.
Product
Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0805-2015·2014-12-24
AMS Monarc Subfascial Hammock Kits Recalled for Packaging Integrity Concerns
American Medical Systems is recalling Monarc + and Monarc C Subfascial Hammock kits because routine testing showed the sterile packaging might fail during extreme shipping.
Product
AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 72404195, Sterilized Using Ethylene Oxide. The Monarc + and Monarc C subfascial hammocks are sterile, single use procedure kits, each consisting…
Category
Medical Device
Distribution
Distributed nationwide

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