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

40201–40225 of 40480

ModerateFDA (Devices)·Z-2059-2012·2012-08-01
Synthes Recalls 4.5mm Multiloc Screws Due to Incorrect Size Labeling
Synthes USA is recalling 20 units of 4.5mm Multiloc Screws because they were incorrectly labeled with the wrong screw size.
Product
4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 38MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2071-2012·2012-08-01
Exactech Recalls Optetrak Tibial Trays Due to Potential Mislabeled Components
Exactech is recalling 12 Optetrak tibial trays because they have the potential to be mislabeled. The affected trays were distributed in the US and several international countries.
Product
Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENTED***CoCr Alloy***SIZE 2F/1T***REF 260-04-21***Exactech Gainesville, FL 32653-1630***. The Exactech Optetrak RBK Total Knee System is indicated for use in skeletally mature individuals undergoing…
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2069-2012·2012-08-01
AGFA IMPAX CV Reporting Software Recalled for Incorrect Stenosis Display
AGFA Corp. is recalling IMPAX CV Reporting software versions 2.03 to 2.08 because selecting 'Left stenosis' incorrectly displays 'Right stenosis' in printed reports.
Product
IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2078-2012·2012-08-01
Siemens syngo.plaza Radiological Image Processing System Recalled for Malfunction
Siemens is recalling two syngo.plaza radiological image processing systems due to a potential malfunction where images may fail to load without an error message.
Product
Siemens syngo.plaza. Radiological image processing system
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2053-2012·2012-08-01
Leica M525 F50 Surgical Microscope Recalled for Illumination Malfunction
Leica Microsystems is recalling M525 F50 surgical microscopes because a malfunction can cause reduced illumination when used with specific remote control adapters.
Product
Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse, Heerbrugg, Switzerland Product Usage: The intended use of this device is for improving visibility of objects through magnification and illumination. It…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2060-2012·2012-08-01
Synthes Recalls 4.5mm Multiloc Screws Due to Incorrect Size Labeling
Synthes USA is recalling two lots of 4.5mm Multiloc Screws because they were incorrectly labeled with the wrong screw size.
Product
4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 28MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2084-2012·2012-08-01
Stryker Recalls Tibial Punch Tower Assembly Due to Undersized Slot
Stryker Howmedica Osteonics is recalling 152 units of Tibial Punch Tower Assemblies because an undersized slot may prevent keel punches from being inserted.
Product
Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics Corp., 59 Route 17, Allendale, NJ 07401. During primary Scorpio TKA procedures, the Scorpio Tibial Punch Tower (8000-1089) is used in conjunction with Scorpio Tibial Keel Punches…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2057-2012·2012-08-01
OrthoPediatrics PediLoc Locking Plate System Recalled for Incorrect Left-Right Labeling
OrthoPediatrics Corp is recalling 15 PediLoc Locking Plate System devices because they are left-sided plates incorrectly labeled and etched as right-sided.
Product
OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures.
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-2070-2012·2012-08-01
Exactech Recalls Optetrak Knee Trays Due to Potential Mislabeled Components
Exactech is recalling specific Optetrak knee replacement trays because they may be mislabeled. The recall covers 16 units distributed in the US and several international countries.
Product
Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 204-04-21***". The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature…
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2079-2012·2012-08-01
Getinge 9100-Series Washer Disinfectors Recalled for Ground Fault Breaker Error
Getinge USA Inc is voluntarily recalling 8 large capacity washer disinfectors due to a production error in the ground fault breaker.
Product
Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and drying of moisture and temperature stable Hospital case carts, sterilization containers, material handling carts, stands and utensils.…
Category
Medical Device
Distribution
5 states
CriticalFDA (Devices)·Z-2014-2012·2012-07-25
Etac Walker Recall Due to Wheel Detachment and Fall Risk
Etac Supply Center Ab is recalling Ono, Avant, and Salsa walkers because wheels may fall off, posing a risk of serious injury or death.
Product
Etac¿ Ono Walker, Etac¿ Avant Walker, and Etac¿ Salsa Walker. These products are four-wheeled walkers intended as a walking aid for indoor and outdoor use for persons weighing up to 125 KG.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2006-2012·2012-07-25
CareFusion EnVe Ventilator Recalled for PEEP Pressure Control Failure
CareFusion 203, Inc. is recalling 266 EnVe Ventilators because they may fail to hold set pressure values or alarm for circuit faults, potentially compromising patient ventilation.
Product
CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and transport environments as a source of continuous or intermittent positive…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1992-2012·2012-07-25
B. Braun Infusomat Space Pump Recall for Anti-Free Flow Clip Defect
B. Braun Medical is recalling 38,225 Infusomat Space Pumps because the anti-free flow clip catch may break if the IV set is inserted incorrectly.
Product
Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G030002, and 686G030102. Intended for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2027-2012·2012-07-25
GE OEC 8800 Flexiview Imaging Device Recall for Defective Power Supply
GE OEC Medical Systems is recalling OEC 8800 Flexiview imaging devices because an FDA inspection found a defective vertical lift column power supply subject to early life failure.
Product
OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The OEC 8800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2037-2012·2012-07-25
Hitachi Scenaria CT System Software Recall for Reconstruction Error
Hitachi is recalling Scenaria CT System software due to a defect that may cause incomplete image reconstruction, potentially resulting in missing diagnostic data.
Product
Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the Scenaria can be…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2009-2012·2012-07-25
Terumo Advanced Perfusion System 1 Recalled for Network Power Failures
Terumo is recalling 992 Advanced Perfusion System 1 units worldwide due to reports of communications and power failures in the system network.
Product
Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 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 used…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2034-2012·2012-07-25
Epocal Recalls BGEM Test Cards for Potential Low Glucose Results
Epocal Inc is recalling 8,650 epoc Blood Analysis BGEM Test Cards because a portion of the lot may report inaccurate low glucose results.
Product
epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2022-2012·2012-07-25
LMA Esophageal Intubation Detector Recalled for Potential False Positive Readings
LMA North America Inc is recalling 18,799 units of the LMA Esophageal Intubation Detector (EID100) because the device may produce false positive results during intubation confirmation.
Product
LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2026-2012·2012-07-25
GE OEC Motorized C-Arm Systems Recalled for Defective Power Supply
GE OEC Medical Systems is recalling OEC 9800 series motorized C-arm systems because a defective vertical lift column power supply is subject to early life failure.
Product
OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The OEC 9800 is designed to provide fluoroscopic and…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2049-2012·2012-07-25
Terumo Sarns Modular Perfusion System 8000 Recalled for Air Bubble Detection Malfunctions
Terumo is recalling 81 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.
Product
Sarns Modular Perfusion System 8000 base, 5 pump 100V. he 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 used by a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2044-2012·2012-07-25
Terumo Sarns Modular Perfusion System 8000 Recalled for Air Bubble Detection Malfunctions
Terumo Cardiovascular Systems is recalling 274 Sarns Modular Perfusion System 8000 units due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.
Product
Sarns Modular Perfusion System 8000 base, 4 pump 115V. 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 used by a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2041-2012·2012-07-25
Varian Eclipse Treatment Planning System Recall for Radiotherapy Prescription Errors
Varian is recalling Eclipse Treatment Planning Systems because changing dose prescriptions in certain plans may result in incorrect Monitor Units and dose distributions.
Product
Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2046-2012·2012-07-25
Terumo Sarns Modular Perfusion System 8000 Recalled for Air Bubble Detection Malfunctions
Terumo is recalling 461 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.
Product
Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. 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 used by…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2036-2012·2012-07-25
Teleflex Medical Recalls Hudson RCI Concha Therm Neptune Humidifiers
Teleflex Medical is recalling Hudson RCI Concha Therm Neptune Humidifiers because a speaker failure could prevent audio alarms from sounding, potentially delaying patient treatment.
Product
Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usage: Device that is intended to add moisture to, and sometime to warm, the breathing gases for administration to a patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2025-2012·2012-07-25
GE OEC 9900 Elite C-arm System Recalled for Power Supply Defect
GE OEC recalled 726 OEC 9900 Elite C-arm systems worldwide due to a defective vertical lift column power supply identified during an FDA inspection.
Product
OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures. The system is an aid to locate anatomical structures during open or percutaneous surgical procedures.…
Category
Medical Device
Distribution
0 states

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40201–40225 of 40480