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

20926–20950 of 40339

HighFDA (Devices)·Z-1295-2019·2019-05-15
Siemens Cios Alpha C-arm X-ray System Recalled for Component Wear
Siemens is recalling two Cios Alpha mobile X-ray systems because continuous high-output operation may cause premature failure of radiation components.
Product
Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1302-2019·2019-05-15
Zimmer Biomet Recalls T7 Driver Cannulated AO Due to Fracture Risk
Zimmer Biomet is recalling 5,885 T7 Driver Cannulated AO units because they may fracture, bend, or shear during use.
Product
T7 Driver Cannulated AO (Part Number 110018531) Product Usage: The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1309-2019·2019-05-15
ConMed Anchor Tissue Retrieval System Recalled for Seal Defects
Conmed Corporation is recalling Anchor Tissue Retrieval Systems due to seal defects that may compromise sterility. The recall affects 7,930 units distributed in the US and 13 other countries.
Product
ConMed Anchor Tissue Retrieval System", 12 MM, 300 ML (5/BX) Catalog Number: TRS-ROBO-12 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1282-2019·2019-05-15
Medtronic Guardian Connect App Recalled for Silent Operating System Shutdowns
Medtronic is recalling the Guardian Connect App because the operating system may close it without warning, preventing users from receiving critical blood glucose alerts.
Product
Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1304-2019·2019-05-15
ConMed Anchor Tissue Retrieval System Recalled for Seal Defects
ConMed is recalling Anchor Tissue Retrieval Systems because voids or partial seals may compromise sterility. The recall covers units distributed worldwide.
Product
ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1306-2019·2019-05-15
ConMed Anchor Tissue Retrieval System Recalled for Sterility Seal Defects
ConMed is recalling Anchor Tissue Retrieval Systems due to seal defects that may compromise sterility. The recall covers 5,034 units distributed worldwide.
Product
ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:TRS190SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1303-2019·2019-05-15
Zimmer Biomet Recalls T7 Driver Solid AO Due to Fracture Risk
Zimmer Biomet is recalling 1,924 T7 Driver Solid AO units because they may fracture, bend, or shear during use.
Product
T7 Driver Solid AO (Part Number 110018541) Product Usage: The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1285-2019·2019-05-15
Cardinal Health Recalls ChemoPlus Goggles Due to Latex Mislabeling
Cardinal Health is recalling ChemoPlus Protective Wrap-around Goggles because the kit labels state they are latex-free, but the goggle straps contain natural rubber latex.
Product
ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1286-2019·2019-05-15
Cardinal Health Recalls ChemoPlus Chemo Spill Kits Due to Latex
Cardinal Health 200, LLC is recalling ChemoPlus Chemo 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, Home Health Kit Product Code:DP5108K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1305-2019·2019-05-15
ConMed Anchor Tissue Retrieval System Recalled for Seal Defects
ConMed is recalling Anchor Tissue Retrieval Systems because voids or partial seals may compromise the sterility of the product.
Product
ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX) Catalog Number: TRS175SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1307-2019·2019-05-15
ConMed Anchor Tissue Retrieval System Recalled for Seal Defects
Conmed Corporation is recalling the Anchor Tissue Retrieval System due to seal defects that may compromise sterility.
Product
ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog Number: TRS-VATS-15 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1298-2019·2019-05-15
Siemens Cios Alpha Mobile X-ray System Recalled for Component Wear
Siemens is recalling 257 Cios Alpha mobile X-ray systems because continuous high-output use may cause premature failure of radiation components.
Product
Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1283-2019·2019-05-15
Cardinal Health Recalls ChemoPlus Spill Kits Due to Latex Mismatch
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:CT4004 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-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

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20926–20950 of 40339