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

30751–30775 of 40325

ModerateFDA (Devices)·Z-1075-2016·2016-03-16
Ortho-Clinical VITROS 5,1 FS Chemistry System Recall for Software Defect
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to increased error codes generated when using a specific calibrator lot.
Product
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132; and VITROS 5,1 FS Chemistry System (Refurbished), Catalog Number 6801890, Unique Device Identifier Number 10758750001644; IVD. Product Usage: The VITROS 5,1 FS Chemistry…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1070-2016·2016-03-16
Conformis iTotal Knee Replacement System Recalled for Incorrect Component
ConforMIS, Inc. is recalling a specific unit of the iTotal Cruciate Retaining Knee Replacement System because an incorrect femoral component was distributed.
Product
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1049-2016·2016-03-16
GE Medical Systems Recalls CT and PET CT Scanners for Incorrect Torque Values
GE Medical Systems is recalling 817 CT and PET CT scanner systems worldwide because service manuals contained incorrect torque values.
Product
Discovery LS, 2286327 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation…
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1051-2016·2016-03-16
GE Medical Systems Recalls CT and PET CT Scanners for Incorrect Torque Values
GE Medical Systems is recalling 324 CT and PET CT scanners worldwide because service manuals contained incorrect torque values.
Product
LightSpeed 16 (MDAS only , , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body…
Category
Medical Device
Distribution
4 states
LowFDA (Devices)·Z-1048-2016·2016-03-16
GE Medical Systems Recalls CT and PET CT Scanners for Service Manual Error
GE Medical Systems is recalling 25 CT and PET CT scanner systems because their service manuals contain an incorrect torque value.
Product
LightSpeed Ultra (8-slice MDAS), 5120327-3 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole…
Category
Medical Device
Distribution
4 states
LowFDA (Devices)·Z-1052-2016·2016-03-16
GE Medical Systems Recalls CT and PET CT Scanners for Manual Error
GE Medical Systems is recalling specific CT and PET CT scanners because service manuals contained an incorrect torque value.
Product
LightSpeed Plus (4-slice MDAS LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body…
Category
Medical Device
Distribution
4 states
LowFDA (Devices)·Z-1053-2016·2016-03-16
GE Medical Systems Recalls CT and PET Scanners for Incorrect Torque Values
GE Medical Systems is recalling 104 CT and PET/CT scanners worldwide because service manuals contained incorrect torque values.
Product
LightSpeed QX/I (4-slice MDAS) LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body…
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-1024-2016·2016-03-09
Philips SENSE Body Coil 1.5T Recalled for Potential Patient Burns
Philips is recalling 5,672 SENSE Body Coil 1.5T units because improper cable placement can cause patient burns during MRI scans.
Product
SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1027-2016·2016-03-09
NeoCoil 3.0T GEM Flex Coil Recalled for Potential Burn Risk
NeoCoil, LLC is recalling 2,121 units of the 3.0T GEM Flex Coil system due to a potential for higher than specified surface temperatures that may result in patient warming or burns.
Product
NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box. 3.0T GEM Flex, Interface 16ch Fixed, P -Connector, NC032204, GEHC part number 5430008-5. 3.0T GEM Flex Coil16-L Array, NC040200, GEHC part number 5430008-2.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1031-2016·2016-03-09
Mako Surgical Recalls Restoris Knee Implants Due to Packaging Damage
Mako Surgical Corporation is recalling 146 units of the Restoris Multicompartmental Knee System because damaged packaging may have compromised the sterile barrier.
Product
Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1028-2016·2016-03-09
Cook Inc. Recalls Kopans Breast Lesion Localization Needles
Cook Inc. is recalling 134 Kopans Breast Lesion Localization Needles because they may have been exposed to body fluids during processing, posing a potential risk of blood-borne pathogen transmission.
Product
Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle with centimeter markings and a hookwire. The hookwire features a burnish mark that allows the operator to ensure that the hookwire is within the needle tip…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1022-2016·2016-03-09
Philips Recalls BrightView XCT Gamma Cameras Due to Mechanical Defects
Philips is recalling 427 BrightView XCT gamma cameras because the collimator may contact the patient pallet or the gantry may halt prematurely during scans.
Product
BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1030-2016·2016-03-09
Siemens Dimension Vista B2 Microglobulin Reagent Cartridge Recall
Siemens Healthcare Diagnostics is recalling Dimension Vista B2 Microglobulin reagent cartridges due to increased abnormal assay errors and calibration failures that may produce inaccurate patient results.
Product
Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalog #K7024 SMN: 10445889 Lot #15246MA Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B2-microglobulin in human serum…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1026-2016·2016-03-09
Ivoclar Vivadent Recalls Helioseal Clear Pit and Fissure Sealant
Ivoclar Vivadent is recalling Helioseal Clear dental sealant because a production error may prevent the material from curing properly under specific lights.
Product
Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1025-2016·2016-03-09
Karman Healthcare Recalls Karma Flexx Wheelchairs Due to Incorrect Hardware
Karman Healthcare is recalling 35 Karma Flexx manual wheelchairs because incorrect size screws and hardware were installed on the front caster fork brackets.
Product
Karma Flexx Wheelchair Manual Wheelchair.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1044-2016·2016-03-09
ConvaTec Recalls Opti-Mist Nebulizer Masks Due to Reduced Aerosol Output
ConvaTec is recalling Opti-Mist and Opti-Mist Clear nebulizer masks because a component defect reduces or stops aerosol output, potentially preventing patients from receiving medication.
Product
Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1045-2016·2016-03-09
Maquet Extension Device Recalled for Potential Detachment from Operating Table
Maquet is recalling the 1180.19F0 Extension Device because it may unlock and fall from the MAGNUS operating table.
Product
Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, Used to support the upper and lower extremities immediately before, during and after fracture surgery. The Extension Device (1180.19F0) is a table top module for use with the Maquet MAGNUS operating…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1029-2016·2016-03-09
Argon Medical Devices Recalls ClosureFast Introducer Sheath Sets Due to Assembly Error
Argon Medical Devices is recalling specific ClosureFast Introducer Sheath Sets because incorrect sheath lengths were assembled to the devices.
Product
ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1021-2016·2016-03-09
Philips Recalls BrightView X Gamma Cameras Due to Motion and Collision Issues
Philips Medical Systems is recalling 117 BrightView X gamma cameras worldwide due to potential gantry motion halts and collimator contact with the patient pallet.
Product
BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1020-2016·2016-03-09
Philips Recalls BrightView Gamma Cameras Due to Motion and Collision Issues
Philips Medical Systems is recalling 677 BrightView gamma cameras because the collimator may contact the patient pallet or the gantry may halt prematurely during scans.
Product
BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1034-2016·2016-03-09
FDA Recalls Mispackaged Pediatric Feeding Tubes from Covidien
The FDA is recalling 1,330 units of pediatric feeding tubes due to packaging errors where different tube sizes were placed in incorrect packages.
Product
Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 8 Fr/Ch (2.7 mm) x 20" (51 cm); Catalog Number: 461701. Intended for pediatric feeding.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1043-2016·2016-03-09
Aesculap Recalls Mislabelled Knee Implant Packaging for Cementless Use
Aesculap Inc. is recalling 1,232 units of Columbus Revision and EnduRo Knee System packaging labeled as cementless, which are indicated for use with bone cement only.
Product
Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1032-2016·2016-03-09
Novadaq PINPOINT Endoscopic Imaging System Recalled for Manual Error
Novadaq is recalling 110 PINPOINT Endoscopic Fluorescence Imaging Systems because the operator's manual lacks validated sterilization parameters for specific components.
Product
PINPOINT Endoscopic Fluorescence Imaging System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1039-2016·2016-03-09
Stryker AccuPlace Drace Stereotaxic Needle Guide Recalled for Packaging Sterility Risk
Stryker is recalling AccuPlace Drace Stereotaxic Needle Guides because packaging defects may breach sterility. The recall covers 5,800 units distributed nationwide.
Product
50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1038-2016·2016-03-09
Stryker AccuPlace Round Level Needle Guide Recalled for Sterility Breach Risk
Stryker is recalling AccuPlace Round Level Needle Guides because packaging defects may compromise sterility. The recall affects 5,800 units distributed nationwide.
Product
(Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
Category
Medical Device
Distribution
Distributed nationwide

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30751–30775 of 40325