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

20076–20100 of 40124

ModerateFDA (Devices)·Z-1989-2019·2019-07-31
Abbott Immunoglobulin G Diagnostic Assay Recall for IFU Updates
Abbott Laboratories is recalling 11,063 Immunoglobulin G in vitro diagnostic kits to update instructions for use regarding reagents and specimen handling.
Product
Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of immunoglobulin G in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2077-2019·2019-07-31
Getinge Recalls Seven PulsioFlex Monitoring Systems Due to Error Messages
Getinge US Sales LLC is recalling seven PulsioFlex Monitoring Systems because they display an internal error message requiring restart or service.
Product
PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient s biometric data are entered, the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2082-2019·2019-07-31
Medical Intelligence Recalls iGuide System Software Due to False Verification Alerts
Medical Intelligence Medizintechnik GmbH is recalling iGuide System software versions 2.2.0, 2.2.1, and 2.2.2 because the Constant Correlation Check may incorrectly demand verification scans.
Product
IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2014-2019·2019-07-31
Siemens AXIOM Artis MP X-ray Generator Recall for Power Supply Issue
Siemens is recalling 24 AXIOM Artis MP units because a power supply tolerance issue may cause generator failure, preventing X-ray procedures.
Product
AXIOM Artis MP, Model Number 5904466
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1992-2019·2019-07-31
Abbott C4 In Vitro Diagnostic Assay Recall for Instruction Manual Updates
Abbott Laboratories is recalling 8,037 C4 in vitro diagnostic assay kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.
Product
C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2000-2019·2019-07-31
Terumo Sur-vet Needle Recall Due to Potential Sterility Compromise
Terumo Medical Corporation is recalling 638,000 Sur-vet Needles due to a potential loss of package integrity that may compromise sterility.
Product
Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-2007-2019·2019-07-31
Becton Dickinson Recalls 3mL Luer-Lok Syringes With Incorrect Scale Markings
Becton Dickinson is recalling 3mL Luer-Lok syringes because the scale markings were printed incorrectly, resulting in missing or partially printed numbers and lines.
Product
3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-2012-2019·2019-07-31
Siemens AXIOM Artis FC X-ray Generator Recall for Power Supply Defect
Siemens is recalling five AXIOM Artis FC units due to a power supply tolerance issue that may cause generator failure and prevent X-ray imaging.
Product
AXIOM Artis FC, Model Number 5904433
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2034-2019·2019-07-31
Siemens Artis zeego X-ray Generator Recall for Power Supply Tolerance Issue
Siemens Medical Solutions is recalling 117 Artis zeego units due to a power supply tolerance issue that can cause generator failure and prevent X-ray imaging.
Product
Artis zeego, Model Number 10280959
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2062-2019·2019-07-31
Merge PACS Software Recalled for Mammography Image Display Errors
Merge Healthcare is recalling specific versions of Merge PACS software because mammography images may not display in the correct reverse chronological order.
Product
Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2032-2019·2019-07-31
Siemens Artis zee floor MN X-ray generator recall
Siemens is recalling 23 Artis zee floor MN units due to a power supply tolerance issue that may cause generator failure and prevent X-ray imaging.
Product
Artis zee floor MN, Model Number 10094142
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1988-2019·2019-07-31
Abbott Immunoglobulin A Diagnostic Assay Recalled for Instruction Manual Errors
Abbott Laboratories is recalling 12,995 Immunoglobulin A diagnostic kits because the instructions for use contained errors in the reagents and specimen handling sections.
Product
Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1994-2019·2019-07-31
Abbott Apolipoprotein B Assay Recalled for Instruction Manual Updates
Abbott Laboratories is recalling 2,273 Apolipoprotein B in vitro diagnostic kits because the Instructions for Use (IFU) required updates to reagent and specimen handling sections.
Product
Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of apolipoprotein B in human serum or plasma. Antibodies to apolipoprotein B combine with apolipoprotein B in the sample to form insoluble immune complexes. The immune complexes cause an…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2008-2019·2019-07-31
Becton Dickinson Recalls 3mL Safety-Lok Syringes Due to Incorrect Scale Markings
Becton Dickinson is recalling 428,800 3mL Safety-Lok Syringes because the scale markings were printed incorrectly, resulting in missing or partially printed numbers and lines.
Product
3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-2020-2019·2019-07-31
Siemens AXIOM Artis dFC X-ray Generator Recall for Power Supply Issue
Siemens is recalling 148 AXIOM Artis dFC units because a power supply defect may cause the X-ray generator to fail during procedures.
Product
AXIOM Artis dFC, Model Number 7412807
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1990-2019·2019-07-31
Abbott Immunoglobulin M Diagnostic Assay Recalled for Instruction Manual Errors
Abbott Laboratories is recalling 9,586 Immunoglobulin M diagnostic kits because the instructions for use contained errors in the reagents and specimen handling sections.
Product
Immunoglobulin M is an in vitro diagnostic assay for the quantitative determination of immunoglobulin M in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1995-2019·2019-07-31
Abbott Transferrin Assay Recalled for Instruction Manual Updates
Abbott Laboratories is recalling 22,359 Transferrin in vitro diagnostic kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.
Product
Transferrin is an in vitro diagnostic assay for the quantitative determination of transferrin in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1991-2019·2019-07-31
Abbott Apolipoprotein A1 Assay Recalled for Instruction Manual Updates
Abbott Laboratories is recalling 2,112 Apolipoprotein A1 assay kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.
Product
Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Antibodies to apolipoprotein A1 combine with apolipoprotein A1 in the sample to form insoluble immune complexes. The immune complexes cause an…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2068-2019·2019-07-31
Epimed Versa-Kath Mini Kit Recalled for Incorrect Catheter Size Labeling
Epimed International is recalling 200 Versa-Kath Mini Kits because the labeling incorrectly states a 12-gauge catheter is included, while the kit actually contains a 21-gauge catheter.
Product
Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 311291155 for epidural or caudal anesthesia
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-2001-2019·2019-07-31
Terumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity
Terumo Medical Corporation is recalling 440,000 Sur-vet Needles due to a potential loss of package integrity that may compromise sterility.
Product
Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-1993-2019·2019-07-31
Abbott Haptoglobin Assay Recalled for Instruction Manual Updates
Abbott Laboratories is recalling 5,694 Haptoglobin Assay kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.
Product
The,K -ASSAY HP assay is intended for the quantitative determination of human haptoglobin by immunoturbidimetric assay. The antiserum used in the kit was produced against purified human haptoglobin. The haptoglobin antibody interacts with the haptoglobin in the serum forming…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2024-2019·2019-07-31
Siemens AXIOM Artis dFA Recalled for Power Supply Tolerance Issue
Siemens is recalling 39 AXIOM Artis dFA units because a power supply issue may cause generator failure, preventing X-ray production during procedures.
Product
AXIOM Artis dFA, Model Number 7555373
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2006-2019·2019-07-31
Terumo 30G Needle Recall Due to Potential Sterility Compromise
Terumo Medical Corporation is recalling 81,000 30G needles due to a potential loss of package integrity that may compromise sterility.
Product
Terumo Needle, 30G x 1/2", Product Code NN3013R
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-1998-2019·2019-07-31
Terumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity
Terumo Medical Corporation is recalling 729,000 Sur-vet Needles because a potential loss of package integrity may compromise the sterility of the product.
Product
Terumo Sur-vet Needle, 20G x 1", Product Code 100204
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-2017-2019·2019-07-31
Siemens AXIOM Artis dBC X-ray System Recalled for Power Supply Issue
Siemens is recalling one AXIOM Artis dBC X-ray system because a power supply defect may prevent X-ray generation during procedures.
Product
AXIOM Artis dBC, Model Number 5917054
Category
Medical Device
Distribution
Distributed nationwide

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20076–20100 of 40124