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

20951–20975 of 40248

ModerateFDA (Devices)·Z-1241-2019·2019-05-08
Bard Medical Recalls ArcticGel Pads Due to Adhesion Defects
Bard Medical Division is recalling specific lots of ArcticGel Pads because the hydrogel may not adhere properly to the pad.
Product
Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGel Medium Pad Kit, 31707I c) Intrepid ArcticGel Large Pad Kit, 31709I d) Intrepid ArcticGel Universal Pad, 31700I e) ArcticGel…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1245-2019·2019-05-08
Siemens CT Scanner Recall for Potential Scan Abortion in Dual Energy Mode
Siemens Medical Solutions is recalling 53 SOMATOM Definition Edge CT scanners due to a software issue that may cause scans to abort in Dual Spiral Dual Energy mode.
Product
SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1258-2019·2019-05-08
GE Healthcare Recalls Discovery NM/CT 670 CZT Systems for Mounting Defect
GE Healthcare is recalling three Discovery NM/CT 670 CZT systems because detector screws may not be secured correctly, potentially compromising detector mounting redundancy.
Product
Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1256-2019·2019-05-08
Lin-Zhi International Recalls Ethyl Alcohol Enzymatic Assay Kits
Lin-Zhi International Inc is recalling 49 Ethyl Alcohol Enzymatic Assay kits due to potential detergent contamination that may reduce shelf life.
Product
Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1253-2019·2019-05-08
Carolina Liquid Chemistries Recalls Ethyl Alcohol Assay Kits
Carolina Liquid Chemistries is recalling 20 Ethyl Alcohol Assay Kits because supplier testing showed the absorbance rate did not meet internal quality control specifications.
Product
CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
Category
Medical Device
Distribution
10 states
LowFDA (Devices)·Z-1252-2019·2019-05-08
Carolina Liquid Chemistries Recalls 14 Etha RGT. Kits for Quality Issues
Carolina Liquid Chemistries is recalling 14 Etha RGT. Kits (Lot 11686) due to quality concerns. The recall is voluntary and has been terminated.
Product
CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
Category
Medical Device
Distribution
10 states
CriticalFDA (Devices)·Z-1116-2019·2019-05-01
Edwards Lifesciences Recalls Fogarty Dilation Atrioseptostomy Catheters
Edwards Lifesciences is recalling Fogarty Dilation Atrioseptostomy Catheters due to reports of balloon fragmentation or detachment and difficulty deflating the balloon after deployment.
Product
Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1219-2019·2019-05-01
CryoLife Pulmonary Hemi-Artery Patch Recalled for Donor Infection
CryoLife is recalling a pulmonary hemi-artery patch because the tissue donor tested positive for Enterobacter cloacae.
Product
CryoPatch SG Pulmonary Hemi-Artery Patch
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1117-2019·2019-05-01
Edwards Miller Balloon Atrioseptostomy Catheter Recalled for Deflation Issues
Edwards Lifesciences is recalling Miller Balloon Atrioseptostomy Catheters due to difficulty deflating the balloon and reports of fragmentation or detachment.
Product
Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830515F Product Usage: The Miller balloon atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1211-2019·2019-05-01
Covidien Endo Clinch II Auto Suture Grasper Recalled for Sterilization Issues
COVIDIEN LLC is recalling 7,248 units of the Endo Clinch II Auto Suture Grasper because the sterilization method used was not consistent with the labeling and approved method.
Product
Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and is designed for introduction and use through the appropriately sized…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1214-2019·2019-05-01
TriMed Hex Cortical Screw Recalled for Shorter Than Specified Length
TriMed Inc. is recalling 13 Hex Cortical Screws from the Ankle Fixation System because they are shorter than the intended design specification.
Product
TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. The HEX4.0 40 bone screw is a component of the TriMed Ankle Fixation System. The HEX4.0-40 Screw is a single piece machined cortical bone screw. The…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1217-2019·2019-05-01
FDA Recalls Safety Winged Blood Collection Sets Due to Needle Detachment
Guangzhou Improve Medical Instruments is recalling 550,000 Prevent G Safety Winged Blood Collection Sets because the hub needle detached during use.
Product
Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage: The IMPROSAFE Blood Collection Set is single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1209-2019·2019-05-01
Fresenius Kabi CATSmart Autotransfusion Device Recalled for Tubing Wear Risk
Fresenius Kabi is recalling 342 CATSmart autotransfusion devices because tubing may contact the washing chamber, causing wear or puncture.
Product
Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set, 9108504 ATF 120 Fast Start Kit, and 9108494 ATF 40 Fast Start Kits); 2. AT-3 Autotransfusion sets and kits…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1205-2019·2019-05-01
Brainlab RT Elements Software Recalled for Incorrect Dose Calculation
Brainlab AG is recalling specific versions of RT Elements software due to a potential for incorrect dose distribution calculations when using the Pencil Beam algorithm on the GPU.
Product
RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected: - Cranial SRS 1.0.0 and 1.5.0 - Spine SRS 1.0.0 and 1.5.0 - Multiple Brain Mets SRS 1.5.0…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1204-2019·2019-05-01
Siemens Digital Linear Accelerators Recalled for Motion Protection Safety Advisory
Siemens Medical Solutions USA is recalling 120 digital linear accelerators nationwide to prevent patient or user injury from disabling the Automatic Motion Protection function.
Product
Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR Impression ONCOR Impression Plus ONCOR Avant Garde ONCOR Expression ARTISTE, ONCOR, and PRIMUS running the following: Control Console from software…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1222-2019·2019-05-01
Ortho-Clinical Diagnostics Recalls VITROS XT 7600 Systems Due to Software Error
Ortho-Clinical Diagnostics is recalling 80 VITROS XT 7600 Integrated Systems because a software error may cause incorrect test results without alerting the user.
Product
VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1203-2019·2019-05-01
Thoratec HeartMate 3 Coring Tool Recalled for Foreign Particle Contamination
Thoratec Corp. is recalling HeartMate 3 Coring Tools because a small black plastic particle was observed in a patient's left ventricle during an implant procedure.
Product
Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1206-2019·2019-05-01
Arthrex Burr Recalled for Excessive Heat Generation During Use
Arthrex, Inc. is recalling specific lots of Arthrex Oval Burr devices because they may generate excessive heat during use, posing a risk of injury to patients.
Product
Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous tissues in both large and small articular cavities during arthroscopic procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1215-2019·2019-05-01
Stryker Performance Series Sagittal Blade Recall for Sterility Breach
Stryker is recalling 355 Performance Series Sagittal Blades due to a potential breach in sterility caused by improper packaging positioning during manufacture.
Product
Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades are used in the cutting and shaping of bone and other bone related tissue in various orthopedic procedures. Typical procedures include, total-knee…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1218-2019·2019-05-01
Jelco ViaValve Safety Intravenous Catheters Recalled for Manufacturing Defect
Smiths Medical ASD Inc. is recalling specific lots of Jelco ViaValve safety intravenous catheters due to a V-shaped puncture at the base of the catheter.
Product
Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The Jelco(R) ViaValve(TM) safety I.V. catheter is a sterile, non pyrogenic, single use, radiopaque intravascular catheter device used for the administration of medically…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1207-2019·2019-05-01
Carestream OnSight 3D Extremity System Recalled for Software Data Error
Carestream Health is recalling 37 OnSight 3D Extremity Systems because a software error may leave companion imaging volumes in the original patient's exam during re-assignment.
Product
OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1213-2019·2019-05-01
Covidien Procedure Kits Recalled for Sterilization Labeling Inconsistency
Covidien LLC is recalling 148 procedure kits because the sterilization method used was not consistent with the labeling and approved method.
Product
Procedure kits include devices from the affected lots distributed OUS only: (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO (2)BOX KIT00680 KIT COLECISTECTOMIA- (3)BOX KIT00681 KIT APENDICECTOMIA (4)BOX KIT00897 KIT COLON IZQUIERDO (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1220-2019·2019-05-01
Abbott Recalls 32 St. Jude Medical Confirm Rx Insertable Cardiac Monitors
Abbott is recalling 32 St. Jude Medical Confirm Rx Insertable Cardiac Monitors because the devices incorrectly determine that their security certificates have expired, preventing them from pairing with the mobile app.
Product
St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It is…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1101-2019·2019-05-01
KaVo Orthopantomograph OP 3D Cone-Beam CT System Firmware Recall
KaVo Dental Technologies is recalling 230 Orthopantomograph OP 3D cone-beam CT systems due to a defect in firmware versions 2.1.0 and 2.1.1.
Product
cone-beam CT system
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1212-2019·2019-05-01
Covidien Endo Grasp Auto Suture Grasper Recalled for Sterilization Labeling Error
COVIDIEN LLC is recalling 240 units of the Endo Grasp Auto Suture Grasper 5mm because the sterilization method used was not consistent with the labeling and approved method.
Product
Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of gynecologic, general, urologic, thoracic and endoscopic procedures for temporary grasping/clamping of tissue and small…
Category
Medical Device
Distribution
Distributed nationwide

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20951–20975 of 40248