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

39776–39800 of 40480

HighFDA (Devices)·Z-2488-2012·2012-10-10
Stanley Tabs Professional Monitor Recalled for Alarm Failure
Stanley Security Solutions is recalling 2,754 Tabs Professional Monitors because they may fail to sound an alarm, potentially increasing the risk of falls.
Product
Tabs Professional Monitor, includes one wall bracket, Model 25022. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2491-2012·2012-10-10
Stanley Security Solutions Recalls Tabs Professional Voice + Monitor Units
Stanley Security Solutions is recalling 4,148 Tabs Professional Voice + Monitor units because the monitor may fail to sound an alarm.
Product
Tabs Professional Voice + Monitor, includes one wall bracket, Model 25222. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2485-2012·2012-10-10
Biomet Recalls OptiLock Screw Inserters Due to Fit Issues
Biomet is recalling 268 OptiLock 2.7 mm Screw Inserters because they may not properly lock into screw heads, posing a risk of improper fixation.
Product
Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2492-2012·2012-10-10
Stanley Security Solutions Recalls Tabs Professional Voice + Monitor Devices
Stanley Security Solutions is recalling 12,111 Tabs Professional Voice + Monitor units because the monitor may fail to sound an alarm.
Product
Tabs Professional Voice + Monitor, with wire bracket, Model 25223. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2489-2012·2012-10-10
Stanley Tabs Professional Monitor Recalled for Alarm Failure
Stanley Security Solutions is recalling 4,749 Tabs Professional Monitors because they may fail to sound an alarm, potentially increasing the risk of falls.
Product
Tabs Professional Monitor, without wall bracket, Model 25023. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0006-2013·2012-10-10
US Endoscopy Raptor Grasping Device Recalled for Potential Jaw Failure
US Endoscopy Group Inc is recalling 1,153 Raptor grasping devices because the jaws may become stuck open if excessive force is applied while the catheter is coiled.
Product
Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2490-2012·2012-10-10
Stanley Tabs Professional Monitor Recalled for Alarm Failure
Stanley Security Solutions is recalling 176 Tabs Professional Monitor units because they may fail to sound an alarm, potentially increasing the risk of falls.
Product
Tabs Professional Monitor, without pull cord or wall bracket, Model 25025. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0004-2013·2012-10-10
Cure Medical Recalls M16 Straight-Tip Intermittent Urinary Catheters Due to Labeling Error
Cure Medical LLC is recalling M16 straight-tip intermittent urinary catheters because some intermediate boxes are mislabeled as M16C coudé-tip catheters.
Product
Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0003-2013·2012-10-10
Beckman Coulter Recalls IMMAGE Rheumatoid Factor Reagent Due to False Results
Beckman Coulter is recalling specific lots of IMMAGE Rheumatoid Factor reagent because they may produce false abnormal results in patient samples.
Product
IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0001-2013·2012-10-10
Synthes MIRS Spinal Fixation Devices Recalled for Labeling Correction
Synthes is correcting labeling for MIRS spinal fixation devices to emphasize avoiding rod mis-alignment following reported complaints.
Product
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2072-2012·2012-10-10
Eos Imaging Recalls EOS X-ray Systems Due to Generator Failures
Eos Imaging Inc is recalling 12 EOS X-ray systems in the US because the anode controller board can fail, causing generator issues.
Product
EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2487-2012·2012-10-10
Stryker Orthopaedics Recalls Cone Body Trials Due to Metal Shavings
Stryker Howmedica Osteonics Corp. is recalling 10,983 Restoration Modular Cone Body Trials because metal shavings were found in the internal threaded portion.
Product
Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland. The Cone Body Trials simulate the respective Cone Body implants and mate with the stem trials to assist the surgeon in assessing…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0005-2013·2012-10-10
Animas Insulin Pumps Recalled for Keypad Wear and Peeling
Animas Corporation is recalling insulin pumps due to keypad wear that may cause tearing or peeling. The recall covers 236,470 units distributed worldwide.
Product
IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0007-2013·2012-10-10
Invuity Recalls Obsolete BriteField Illuminated Suction Devices
Invuity is recalling 197 obsolete BriteField Illuminated Suction Devices nationwide. The devices were not distributed after March 2011.
Product
BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0002-2013·2012-10-10
Beckman Coulter PrepPlus Recalled for Reagent Level Sense Failures
Beckman Coulter is recalling the PrepPlus pipetting system because it may fail to warn users when reagent levels are low or out.
Product
COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0010-2013·2012-10-10
C.R. Bard Recalls Pediatric Foley Catheters with Incorrect Valve Cap Labeling
C.R. Bard is recalling 4,032 units of 8 Fr. Bardex Pediatric All-Silicone Foley Catheters because the valve cap displays an incorrect inflation volume of 10 ml instead of 5 ml.
Product
8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0008-2013·2012-10-10
Gynex Electrosurgical Electrode Holder Recalled Due to Assembly Error
Gynex Corporation is recalling 19 boxes of electrosurgical electrode holders because an incorrect connector pin was attached during assembly, rendering the devices unusable.
Product
Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "***GYNEX*** Electrode Handpiece, Foot Activated*** Manufactured for GYNEX***" Gynex catalog number: 950 (Gynex REF…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2437-2012·2012-10-03
FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk
The FDA is recalling 268,022 units of the Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6035A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2435-2012·2012-10-03
FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk
The FDA is recalling 104,355 units of the Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4548A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2462-2012·2012-10-03
Varian Eclipse Treatment Planning System Recalled for Dose Calculation Error
Varian is recalling Eclipse Treatment Planning Systems because a clock synchronization issue can cause incorrect dose calculations, potentially leading to under- or over-dosing of patients.
Product
Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2436-2012·2012-10-03
FDA Recalls Covidien Duet TRS Staplers Due to Injury Risk
The FDA is recalling 22,218 units of the Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Product Code: DUET6035. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2439-2012·2012-10-03
FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk
The FDA is recalling 135,712 units of the Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6048A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2432-2012·2012-10-03
FDA Recalls Covidien Duet TRS Staplers Due to Injury Risk
The FDA is recalling 433,528 units of the Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product Code: DUET4535. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2433-2012·2012-10-03
FDA Recalls Covidien Duet TRS Surgical Staplers Due to Injury Risk
The FDA is recalling 94,301 units of the Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4535A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2438-2012·2012-10-03
FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk
The FDA is recalling 15,936 units of the Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET6048. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric…
Category
Medical Device
Distribution
0 states

How to read this listing

Filters

39776–39800 of 40480