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

27751–27775 of 40233

ModerateFDA (Devices)·Z-1073-2017·2017-02-01
Binding Site IgG4 Kit Recalled for Inaccurate Results in High Levels
The Binding Site Group is recalling MininephThl Human IgG4 Kits because samples with extremely high IgG4 levels may yield spuriously low results.
Product
MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1084-2017·2017-02-01
Atrium Medical Oasis Pediatric Drain Recalled for Non-Sterile Packaging
Atrium Medical is recalling Oasis Pediatric Drains because the outer packaging is not sterile. The recall covers 964,463 US cases and 521,975 international cases.
Product
Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric drain with in-line connector, ¿ in. tubing, Sims and Pedi connector in bag on back of drain 3612-400 Oasis Infant/Pediatric drain with no in-line connector, ¿ in. tubing, Sims and Pedi connector…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1088-2017·2017-02-01
Atrium Medical Express Mini 500 Dry Seal Drain Recall
Atrium Medical is recalling Express Mini 500 dry seal drains because the outer packaging is not sterile.
Product
Atrium Medical 16400 Express Mini 500 dry seal drain Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative collection and reinfusion of autologous…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1104-2017·2017-02-01
Mesa Laboratories Recalls ProSpore Biological Indicators Due to Reduced Resistance
Mesa Laboratories is recalling ProSpore 4 mL Ampoule Biological Indicators because product resistance fell outside label claims within the expiration date.
Product
ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care…
Category
Medical Device
Distribution
11 states
LowFDA (Devices)·Z-1102-2017·2017-02-01
PerkinElmer AutoDELFIA System Recalled for Potential Plate Loading Failures
PerkinElmer is recalling AutoDELFIA systems with V3.0 software due to potential plate loading failures that could affect clinical assay results.
Product
DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1101-2017·2017-02-01
PerkinElmer AutoDELFIA System Recalled for Potential Plate Loading Failures
PerkinElmer is recalling AutoDELFIA systems with Version 3.0 software due to potential plate loading failures that could affect clinical assay results.
Product
Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1105-2017·2017-02-01
Smiths Medical Recalls NORMFlow H-1100 Irrigation Fluid Warmer for Labeling Errors
Smiths Medical is recalling one NORMFlow H-1100 Irrigation Fluid Warmer in Sweden due to incorrect Spanish labels instead of English.
Product
NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reorder H-1100-INT-230. Product Usage: NORMOFLO¿ H-1100 Irrigation Fluid Warmers has been designed for safe, in-line warming of irrigating fluids as they are administered to patients. The Fluid Warmer…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1075-2017·2017-02-01
Pentax Rigid Laryngostroboscopes Field Correction for Instructions for Use
Pentax of America is revising the Instructions for Use for Rigid Laryngostroboscopes Models 9106 and 9108.
Product
Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1089-2017·2017-02-01
Binding Site IgG4 Kit Recalled for Incorrect Product Insert Information
The Binding Site Group is recalling Optilite IgG4 Kits because the product insert does not reflect a change to the measuring range.
Product
Optilite IgG4 Kit Product Code: LK009.OPT.A
Category
Medical Device
Distribution
8 states
LowFDA (Devices)·Z-1060-2017·2017-02-01
GE OEC 9900 Elite Surgical Carts Recalled for Documentation Updates
GE Healthcare is updating user documentation for OEC 9900 Elite surgical carts to clarify maintenance and component replacement frequencies.
Product
OEC 9900 Elite. MDL Numbers: D148942, D155043
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1059-2017·2017-02-01
GE OEC 9800 Surgical Table Field Action for Documentation Updates
GE Healthcare is updating user documentation for OEC 9800 surgical tables to clarify maintenance and component replacement schedules.
Product
OEC 9800. MDL Numbers: D222250, D141598
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0970-2017·2017-01-25
Bard Halo One Introducer Sheath Recalled for Separation and Kinking
Bard Peripheral Vascular is recalling Halo One 5F Introducer Sheaths due to complaints of sheath separation, kinking, and tip damage during use.
Product
Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1044-2017·2017-01-25
Elekta Monaco RTP System Recalled for Incorrect Dose Calculation Errors
Elekta, Inc. is recalling the Monaco RTP System because editing beam numbers and wedge angles can result in incorrect dose calculations for radiation therapy patients.
Product
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Category
Medical Device
Distribution
27 states
SevereFDA (Devices)·Z-0977-2017·2017-01-25
BioMerieux NucliSENS magnetic extraction reagents recalled for performance drift
BioMerieux SA is recalling NucliSENS magnetic extraction reagents because a performance drift was observed in BK virus testing for certain silica batches.
Product
NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG¿ is intended to be used for the extraction of total nucleic acids from biological specimens.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1026-2017·2017-01-25
Fresenius 2008T Hemodialysis System Recalled for Software Error
Fresenius Medical Care is recalling 2008T Series Hemodialysis Systems because a software error may cause the machine to execute a cancelled ultrafiltration rate instead of the displayed rate.
Product
Fresenius 2008T Series Hemodialysis System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0950-2017·2017-01-25
CareFusion Recalls Alaris Pump Modules Due to False Air-in-Line Alarms
CareFusion is recalling Alaris Pump Modules and AIL sensor kits because false Air-in-Line alarms can interrupt medication infusions.
Product
Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0969-2017·2017-01-25
Bard Halo One Introducer Sheath Recalled for Separation and Kinking
Bard Peripheral Vascular is recalling Halo One 5F Introducer Sheaths due to reports of sheath separation, kinking, and tip damage during use.
Product
Halo One 5F Introducer Sheath 90 cm Product Code: HAL590 Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0968-2017·2017-01-25
Bard Halo One Introducer Sheath Recalled for Separation and Kinking
Bard Peripheral Vascular is recalling Halo One 5F Introducer Sheaths due to complaints of separation, kinking, and tip damage during use.
Product
Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheathand introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use inperipheral arterial and venous procedures…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1027-2017·2017-01-25
Fresenius 2008K Hemodialysis System Recalled for Software Error
Fresenius Medical Care is recalling 2008K Series Hemodialysis Systems because a software error may cause the machine to execute a cancelled Ultrafiltration Rate setting.
Product
Fresenius 2008K Series : Hemodialysis System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0976-2017·2017-01-25
BioMerieux Recalls MagSIL Magnetic Silica Reagents Due to Performance Drift
BioMerieux SA is recalling 3,723 units of MagSIL (NucliSENS easyMAG Magnetic Silica) worldwide due to observed performance drift in BK virus testing.
Product
MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS¿ easyMAG¿ system is an in vitro diagnostic medical device and is intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1029-2017·2017-01-25
Fresenius 2008K@home Hemodialysis System Recalled for Software Defect
Fresenius Medical Care is recalling 2008K@home hemodialysis systems because a software error may cause the machine to execute a cancelled ultrafiltration rate.
Product
Fresenius 2008K@home Series : Hemodialysis System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1018-2017·2017-01-25
Binding Site Optilite Analyser Recalled for Lid Injury Risk
The Binding Site Group is recalling 129 Optilite Analyser units because the lid may fall suddenly and cause injury if not fully open.
Product
Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. The Indiko…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1053-2017·2017-01-25
Freelite Human Lambda Free Kit Recalled for Calibration Curve Error
The Binding Site Group is recalling Freelite Human Lambda Free Kits due to a calibration curve change that causes an increase in false prozone flags.
Product
Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1046-2017·2017-01-25
Merge Cardio software recalled for potential image loading errors
Merge Healthcare is recalling Merge Cardio software versions 9.0 through 10.1.2 because a specific user action may cause images to be missing, potentially leading to incorrect diagnosis or treatment.
Product
Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1051-2017·2017-01-25
Great Basin Staph ID/R Blood Culture Panel Recalled for False Positives
Great Basin Scientific is recalling the Staph ID/R Blood Culture Panel because the S. aureus probe could result in false positive results.
Product
Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer System. The Staph lD/R Blood Culture Panel is capable of simultaneous detection…
Category
Medical Device
Distribution
Distributed nationwide

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27751–27775 of 40233