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

27176–27200 of 27722

HighFDA (Devices)·Z-0114-2013·2012-10-31
GE Healthcare Recalls innova 3100-IQ Mobile X-ray Systems Due to Filter Failure
GE Healthcare is recalling 199 innova 3100-IQ mobile X-ray systems in the US due to a potential failure of the spectral filter mechanism inside the collimator.
Product
GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0132-2013·2012-10-31
Biosense Webster MobiCath Bi-Directional Guiding Sheath Recalled for Catheter Interaction
Greatbatch Medical is recalling MobiCath Bi-Directional Guiding Sheaths due to a potential interaction with therapeutic catheters that may cause them to self-advance.
Product
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0157-2013·2012-10-31
Sorin Gish Straight Connectors Recalled for Potential Fluid Leakage
Sorin Group USA is recalling specific lots of Gish straight connectors due to a molding defect that may cause fluid leaks or air entrainment.
Product
Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, EC2160S, Lot Numbers: 1210100010, 1215100026, 1217000138, Exp. Dates: 4/16/17, 5/31/15, 7/31/15. Product Usage: The connectors are indicated for use in connecting flexible tubing used in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0121-2013·2012-10-31
GE Healthcare Recalls Discovery NM/CT 670 and NM 630 Systems
GE Healthcare is recalling 210 Discovery NM/CT 670 and NM 630 systems due to a potential safety issue where the table pallet may contact the detector during operation.
Product
GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0130-2013·2012-10-31
Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions
Terumo Cardiovascular Systems is recalling 26 units of the Sarns Modular Perfusion System 8000 due to reported malfunctions in power distribution and battery back-up systems.
Product
Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when…
Category
Medical Device
Distribution
42 states
HighFDA (Devices)·Z-0131-2013·2012-10-31
Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions
Terumo is recalling 81 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in power distribution and battery back-up systems.
Product
Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when…
Category
Medical Device
Distribution
42 states
HighFDA (Devices)·Z-0115-2013·2012-10-31
GE Healthcare recalls innova mobile X-ray systems due to filter failure
GE Healthcare is recalling 199 innova mobile X-ray systems in the US due to a potential failure of the spectral filter mechanism inside the collimator.
Product
GE Healthcare innova 3131-IQ Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0135-2013·2012-10-31
Nipro AquaLiner Hydrophilic Guidewires Recalled for Insufficient Lubricity
Nipro Medical Corporation is recalling AquaLiner Hydrophilic Guidewires because insufficient lubricity causes them to get stuck in the housing and become nonfunctional.
Product
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0139-2013·2012-10-31
Encore Medical Recalls 6.5mm Cancellous Bone Screws Due to Labeling Errors
Encore Medical is recalling 6.5mm Cancellous Bone Screws because some units were mislabeled with incorrect sizes, posing a risk of improper surgical fixation.
Product
6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0107-2013·2012-10-31
Westmed Recalls Arterial Blood Gas Kits Due to Contaminated Alcohol Pads
Westmed is recalling Arterial Blood Gas (ABG) sampling kits because they contain TRIAD brand alcohol pads that are being recalled for potential contaminants.
Product
Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, part number: 3373-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0125-2013·2012-10-31
GE Healthcare Recalls Seno Advantage 2.2 Workstations Due to Scale Factor Errors
GE Healthcare is recalling 12 Seno Advantage 2.2 workstations because inaccurate scale factor annotations may lead to miscalculation of image sizes, potentially impacting patient safety.
Product
GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0126-2013·2012-10-31
Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions
Terumo Cardiovascular Systems is recalling 274 Sarns Modular Perfusion System 8000 units due to reported malfunctions in power distribution and battery back-up systems.
Product
Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when…
Category
Medical Device
Distribution
42 states
HighFDA (Devices)·Z-0116-2013·2012-10-31
Advandx E. coli/P. aeruginosa PNA FISH Kit Recalled for Cross-Reactivity
Advandx Inc is recalling 33 units of the E. coli/P. aeruginosa PNA FISH kit because Pseudomonas putida strains may cross-react, causing false-positive results.
Product
AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number : KT007 Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0127-2013·2012-10-31
Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions
Terumo Cardiovascular Systems is recalling 1,097 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in power distribution and battery back-up systems.
Product
Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when…
Category
Medical Device
Distribution
42 states
HighFDA (Devices)·Z-0129-2013·2012-10-31
Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions
Terumo Cardiovascular Systems is recalling 312 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in power distribution and battery back-up systems.
Product
Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures…
Category
Medical Device
Distribution
42 states
HighFDA (Devices)·Z-0158-2013·2012-10-31
Sorin Gish Reducer Connectors Recalled for Potential Fluid Leakage
Sorin Group USA is recalling specific lots of Gish Reducer Connectors due to a molding defect that may cause fluid leaks or air entrainment.
Product
Gish 3/8 x 1/2" Reducer Connector with Luer fitting, Item Numbers: EC2180S, Lot Numbers: 1108900099, 1119900091, 1203700129, 1208600013, 1219200107, Exp. Dates: 3/31/14, 7/31/14, 2/28/15, 3/31/15, 7/31/15. Product Usage: The connectors are indicated for use in connecting…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0095-2013·2012-10-31
GE Seno Advantage Workstation Recalled for Incorrect Magnification Measurements
GE Healthcare is recalling Seno Advantage Workstations because measurement values may be incorrect for magnification images from non-GE digital mammography systems.
Product
GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1: Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0118-2013·2012-10-31
Elekta Recalls Oncentra External Beam 4.1 Radiation Treatment Planning Software
Elekta, Inc. is recalling 52 units of Oncentra External Beam 4.1 software due to a defect that allows beam weights to be changed during dose calculation without error messages.
Product
Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0104-2013·2012-10-31
Westmed Recalls Arterial Blood Gas Kits Due to Contaminated Alcohol Pads
Westmed is recalling Pulset ABG sampling kits because they contain TRIAD alcohol pads that are being recalled for potential contaminants.
Product
Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 22 g x 1" A/B Needle, 25U Balanced Heparin, part number: 3372. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0097-2013·2012-10-31
Westmed Recalls Arterial Blood Gas Kits Due to Contaminated Alcohol Pads
Westmed is recalling ABG sampling kits containing TRIAD alcohol pads due to potential contaminants in the pads.
Product
Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3165-98. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0113-2013·2012-10-31
GE Healthcare Recalls innova 3100 Mobile X-ray Systems Due to Filter Failure
GE Healthcare is recalling 199 innova 3100 mobile X-ray systems due to a potential failure of the spectral filter mechanism inside the collimator.
Product
GE Healthcare innova 3100, Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0109-2013·2012-10-31
Westmed Recalls Arterial Blood Gas Kits Due to Alcohol Pad Contaminants
Westmed is recalling ABG sampling kits because the included TRIAD alcohol pads may contain potential contaminants.
Product
Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, part number: 3383-95, 3344-95, 3353-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0119-2013·2012-10-31
Biomet 3i Recalls Dental Implants Due to Missing Internal Threading
Biomet 3i is recalling 227 Osseotite Tapered Certain Implants because a small percentage are missing internal threading. The devices were distributed worldwide.
Product
Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple…
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-0128-2013·2012-10-31
Terumo Sarns Modular Perfusion System 8000 Recalled for Power Malfunctions
Terumo CVS is recalling 466 Sarns Modular Perfusion System 8000 units due to reported power distribution and battery back-up malfunctions.
Product
Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures…
Category
Medical Device
Distribution
42 states
SevereFDA (Devices)·Z-0057-2013·2012-10-24
Ethicon Recalls Hemorrhoidal Circular Staplers Due to Firing Defect
Ethicon Endo-Surgery is recalling specific lots of PROXIMATE PPH and Transtar circular staplers because a firing defect may cause incomplete staple formation.
Product
Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: The PROXIMATE HCS Hemorrhoidal Circular Staplers, (PPH01 and PPH03), and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and…
Category
Medical Device
Distribution
Distributed nationwide

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27176–27200 of 27722