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

20826–20850 of 40124

ModerateFDA (Devices)·Z-1289-2019·2019-05-15
Ortho-Clinical VITROS 3600 Immunoassay System Software Recall
Ortho-Clinical Diagnostics is recalling VITROS 3600 Immunoassay System software versions 3.3.2 and below due to a luminometer malfunction that may prevent the processing of MicroWell assays.
Product
VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1300-2019·2019-05-15
Siemens Atellica IM 1600 Analyzer Recalled for Software Issues
Siemens Healthcare Diagnostics is recalling 366 Atellica IM 1600 Analyzers due to multiple issues identified in the system software that required an update.
Product
Atellica IM 1600 Analyzer, Material Number 11066000
Category
Medical Device
Distribution
36 states
ModerateFDA (Devices)·Z-1288-2019·2019-05-15
Ortho-Clinical VITROS 5600 Systems Recalled for Luminometer Malfunction
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a luminometer malfunction that may prevent the processing of MicroWell assays.
Product
VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1294-2019·2019-05-15
Medica Wash1 Solution Recalled for Ineffective Probe Cleaning
Medica Corporation is recalling Wash1 solution because it fails to clean the probe effectively, potentially causing test interference on the EasyRA analyzer.
Product
Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in washing the probe of the Medica EasyRA Chemistry Analyzer. The wash solution in the wedge is used to prevent interference between certain…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1299-2019·2019-05-15
Siemens Atellica IM 1300 Analyzer Recalled for Software Issues
Siemens Healthcare Diagnostics is recalling 277 Atellica IM 1300 Analyzers due to multiple issues identified in the system software that required an update.
Product
Atellica IM 1300 Analyzer, Material Number 11066001
Category
Medical Device
Distribution
36 states
ModerateFDA (Devices)·Z-1291-2019·2019-05-15
Ortho-Clinical Diagnostics Recalls VITROS XT 7600 Systems Due to Luminometer Malfunction
Ortho-Clinical Diagnostics is recalling 62 VITROS XT 7600 Integrated Systems worldwide because a luminometer malfunction may prevent the processing of MicroWell assays.
Product
VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1284-2019·2019-05-15
Cardinal Health Recalls ChemoPlus Spill Kits Due to Latex Inconsistency
Cardinal Health is recalling ChemoPlus chemotherapy spill kits because the safety goggles inside contain natural rubber latex, despite the kit label stating the product is latex-free.
Product
ChemoPlus Chemo Spill Kit Product Code:DP5016K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1293-2019·2019-05-15
Ortho-Clinical VITROS ECi Immunodiagnostic System Recalled for Luminometer Malfunction
Ortho-Clinical Diagnostics is recalling 25 refurbished VITROS ECi Immunodiagnostic Systems because a luminometer malfunction may prevent the processing of MicroWell assays.
Product
VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1297-2019·2019-05-15
Elekta Unity Systems Recalled for Missing Contrast Agent Warnings
Elekta Limited is recalling nine Elekta Unity systems because the user manual lacks a warning regarding the administration of unvalidated contrast agents.
Product
Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1292-2019·2019-05-15
Ortho-Clinical VITROS ECi/ECiQ Immunodiagnostic System Recalled for Luminometer Malfunction
Ortho-Clinical Diagnostics is recalling 45 VITROS ECi/ECiQ Immunodiagnostic Systems worldwide due to a luminometer malfunction that may prevent the processing of MicroWell assays.
Product
VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1290-2019·2019-05-15
Ortho-Clinical Diagnostics Recalls VITROS 3600 Immunoassay Systems Due to Luminometer Malfunction
Ortho-Clinical Diagnostics is recalling 28 VITROS 3600 Immunoassay Systems because a luminometer malfunction may prevent the processing of MicroWell assays.
Product
VITROS¿ 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1287-2019·2019-05-15
Ortho-Clinical Diagnostics Recalls VITROS 5600 Integrated System Software
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated System software versions 3.3.2 and below due to a luminometer malfunction that may prevent the processing of MicroWell assays.
Product
VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1301-2019·2019-05-15
Siemens Atellica Sample Handler Prime Recalled for Software Issues
Siemens Healthcare Diagnostics is recalling 474 Atellica Sample Handler Prime units due to multiple issues identified in the system software that required an update.
Product
Atellica Sample Handler Prime, Material Number 11069001
Category
Medical Device
Distribution
36 states
SevereFDA (Devices)·Z-1250-2019·2019-05-08
Philips Fetal Spiral Electrode Recall Due to Metal Tip Breakage Risk
Philips is recalling Fetal Spiral Electrodes because the metal tip may break off and remain in a newborn's scalp during delivery.
Product
Fetal Spiral Electrode, Model No. 9898 031 37631
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1248-2019·2019-05-08
Baxter SIGMA Spectrum Infusion Pumps Recalled for Flow Rate Testing Errors
Baxter Healthcare is recalling 158 SIGMA Spectrum Infusion Pumps because flow rate tests were performed for less than the required time, potentially leading to inaccurate fluid administration.
Product
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1249-2019·2019-05-08
Roche Recalls cobas e 801 Immunoassay Analyzers Due to Signal Drops
Roche Diagnostics is recalling 149 cobas e 801 immunoassay analyzers because signal drops after bottle changeovers may lead to incorrect medical decisions.
Product
cobas e 801 immunoassay analyzer
Category
Medical Device
Distribution
31 states
SevereFDA (Devices)·Z-1226-2019·2019-05-08
DePuy Spine Recalls Concorde Lift Spinal Fusion Implants Due to Migration
DePuy Spine is recalling Concorde Lift spinal fusion implants because a complaint trend was observed for post-operative loss of height and migration.
Product
Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27 (197811027L), 9x23 (US197809023L), 9x27 (US197809027L)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1263-2019·2019-05-08
GE Healthcare Recalls NM/CT 860 Systems Due to Detector Screw Issue
GE Healthcare is recalling six NM/CT 860 systems because detector screws may not be secured correctly, potentially compromising mounting redundancy.
Product
NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1261-2019·2019-05-08
GE Healthcare Recalls NM 830 Nuclear Imaging Systems for Screw Defect
GE Healthcare is recalling 37 Discovery NM 830 nuclear imaging systems because detector screws may not be secured correctly, potentially compromising mounting redundancy.
Product
NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1251-2019·2019-05-08
Viewray MRIdian Linac Radiation Therapy System Recall for Dose Calculation Discrepancy
Viewray is recalling 17 MRIdian Linac Radiation Therapy Systems due to a discrepancy between optimization and planning forward dose calculations.
Product
MRIdian Linac Radiation Therapy System, Model 20000.
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1247-2019·2019-05-08
Siemens CT Scanners Recalled for Dual Energy Scan Abortion Risk
Siemens is recalling 53 SOMATOM Definition AS CT scanners due to a software issue that may cause scans to abort when using the optional Dual Spiral Dual Energy mode.
Product
SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model Number 8098027 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1266-2019·2019-05-08
GE Healthcare Recalls Optima NM/CT 640 Systems for Detector Screw Issue
GE Healthcare is recalling 35 Optima NM/CT 640 systems because detector screws may not have been secured correctly, potentially compromising mounting redundancy.
Product
Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1262-2019·2019-05-08
GE Healthcare Recalls NM/CT 850 Systems Due to Detector Screw Issue
GE Healthcare is recalling 31 NM/CT 850 systems because detector screws may not have been secured correctly, potentially compromising mounting redundancy.
Product
NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1240-2019·2019-05-08
Philips MR Systems Recalled for Magnet Energization Device Electrical Shock Risk
Philips is recalling four Ingenia Ambition MR systems because the Magnet Energization Device may have residual voltage, posing an electrical shock risk to personnel.
Product
Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a diagnostic device. The purpose of the MED is to supply power to charge the magnet. MED is abbreviation for Magnet Energize Device
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1259-2019·2019-05-08
GE Discovery NM/CT 670 DR Recalled for Potential Detector Screw Issue
GE Healthcare is recalling 11 Discovery NM/CT 670 DR systems because detector screws may not be secured correctly, potentially compromising mounting redundancy.
Product
Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma…
Category
Medical Device
Distribution
0 states

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20826–20850 of 40124