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

39651–39675 of 40480

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
ModerateFDA (Devices)·Z-0108-2013·2012-10-31
Westmed Recalls Arterial Blood Gas Sampling Kits Due to Contaminated Alcohol Pads
Westmed is recalling Pulset Arterial Blood Gas 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, 23g x 1" A Needle w/Eclipse, 25U Balanced Heparin, No CE, part number: 3373-98. 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
ModerateFDA (Devices)·Z-0133-2013·2012-10-31
DePuy Mitek VAPR Hook Electrode Recalled for Incorrect Labeling
DePuy Mitek is recalling 376 VAPR Hook Electrodes because the packaging may display the wrong product identification label.
Product
DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VAPR Electrodes for use with the VAPR Radiofrequency System are intended for resection, ablation, excision, hemostasis of blood vessels, and coagulation…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0123-2013·2012-10-31
Beckman Coulter Recalls DxC 600/800 Analyzers Due to Software Alignment Issue
Beckman Coulter is recalling 7 UniCel DxC 600/800 analyzers because software v5.0.11 prevents operators from performing a necessary alignment procedure.
Product
UniCel¿ DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel¿ DxC Synchron¿ Clinical Systems are fully automated, computercontrolled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and…
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0136-2013·2012-10-31
Nipro AquaLiner Hydrophilic Guidewire 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, Straight/ Regular. 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
ModerateFDA (Devices)·Z-0137-2013·2012-10-31
Nipro AquaLiner Hydrophilic Guidewires Recalled for Insufficient Lubricity
Nipro Medical Corporation is recalling AquaLiner Hydrophilic Guidewires because insufficient lubricity causes the wires to get stuck in the housing and become nonfunctional.
Product
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ 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
ModerateFDA (Devices)·Z-0102-2013·2012-10-31
Westmed Recalls Arterial Blood Gas Kits Due to Alcohol Pad Contaminants
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, w/Crickett 22g x 1", 25U Balanced Heparin, part number: 3362-95. 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
ModerateFDA (Devices)·Z-0138-2013·2012-10-31
Nipro AquaLiner Hydrophilic Guidewire 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 180cm, Angle / Regular. 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
ModerateFDA (Devices)·Z-0117-2013·2012-10-31
Advanced Bionics Recalls HiRes 90K Cochlear Implants Due to Loose Tools
Advanced Bionics is recalling 17 HiRes 90K cochlear implant devices with Helix Electrodes because of loose-fitting insertion tool assemblies.
Product
HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear System is a cochlear implant system designed to provide useful hearing to individuals with severe to profound hearing loss. It consists of internal and external components. The internal…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0112-2013·2012-10-31
Advandx GNR Traffic Light PNA FISH Kit Recalled for False Positives
Advandx Inc is recalling 187 GNR Traffic Light PNA FISH kits because they may produce false positive results for Pseudomonas putida and Pseudomonas fulva.
Product
AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa Catalog number: KT011. GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0098-2013·2012-10-31
Westmed Recalls Arterial Blood Gas Kits Due to Alcohol Pad Contaminants
Westmed is recalling Pulset Arterial Blood Gas 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, 1 cc, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3173-14. 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
ModerateFDA (Devices)·Z-0105-2013·2012-10-31
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 may have potential contaminants.
Product
Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 22g x 1" A Needle, 25U Balanced Heparin, part number: 3372-95. 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
ModerateFDA (Devices)·Z-0096-2013·2012-10-31
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. Modified Kit, Pulset, 1 cc, w/Crickett 25g x 5/8" A Needle, 25U Balanced Heparin, part number: 3165-95. 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
ModerateFDA (Devices)·Z-0134-2013·2012-10-31
Nipro AquaLiner Hydrophilic Guidewire 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/ Regular. 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
ModerateFDA (Devices)·Z-0122-2013·2012-10-31
Orthosensor Recalls Knee Trial Software Due to Signal Interference
Orthosensor is recalling 9 units of Knee Trial software version 1.82 because metal objects in the operating room obstruct the line of sight between the knee balancer and the Link station.
Product
"****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***" Rx Only*** Sterile/EO***Made exclusively for Stryker Orthopaedics***. Is the graphic user interface software associated with the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0099-2013·2012-10-31
Westmed Recalls Arterial Blood Gas Kits Due to Alcohol Pad Contaminants
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. Full Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3173-98. 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
ModerateFDA (Devices)·Z-0024-2013·2012-10-31
Optovue Recalls Reference Materials Shipped with iVue and RTVue Systems
Optovue is recalling 795 units of reference materials shipped with iVue and RTVue systems because they were not included in the FDA clearance.
Product
Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0101-2013·2012-10-31
Westmed Recalls Arterial Blood Gas Kits Due to Alcohol Pad Contaminants
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, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, No B Needle or Q-Cork, part number: 3363-95. 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
ModerateFDA (Devices)·Z-0100-2013·2012-10-31
Westmed Recalls Arterial Blood Gas Kits Due to Contaminated Alcohol Pads
Westmed is recalling Pulset ABG sampling kits because they contain TRIAD brand alcohol pads that are being recalled for potential contaminants.
Product
Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 22g x 1" A Needle, 25U Balanced Heparin, part number: 3342-95. 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
ModerateFDA (Devices)·Z-0106-2013·2012-10-31
Westmed Recalls ABG Sampling Kits Due to Contaminated Alcohol Pads
Westmed is recalling Pulset ABG sampling kits because they contain TRIAD alcohol pads that may have potential contaminants.
Product
Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 23g x 1" A/B Needle, 25U Balanced Heparin, part numbers: 3373, 3393. 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
ModerateFDA (Devices)·Z-0103-2013·2012-10-31
Westmed Recalls Arterial Blood Gas Kits Due to Contaminated Alcohol Pads
Westmed is recalling Pulset Arterial Blood Gas sampling kits because they contain TRIAD brand alcohol pads that are being recalled for potential contaminants.
Product
Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, Luer Slip Barrel, 25U Balanced Heparin, No B Needle or Q-Cork, part number: 3363-95S. An arterial blood sampling kit is a device, in kit form, used to obtain arterial…
Category
Medical Device
Distribution
Distributed nationwide

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39651–39675 of 40480