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 deaths or serious injuries are reported, 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

7201–7225 of 27364

HighFDA (Devices)·Z-1270-2023·2023-09-06
Atellica CH Triglycerides Diagnostic Kit Recalled for Reagent Carryover
Siemens Healthcare Diagnostics is recalling 11,824 units of Atellica CH Triglycerides test kits due to reagent carryover from other test parameters that can affect magnesium measurement accuracy. The FDA classified this as a Class II recall.
Product
Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma (lithium heparin, potassium EDTA) using the Atellica CH Analyzer SMN: 11097591
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2473-2023·2023-09-06
Diagnostic reagent kit recall: potential test result inaccuracy
Siemens is recalling Atellica CH diagnostic reagent kits due to potential reagent carryover that could produce inaccurate test results. This may affect quality control and patient test reliability.
Product
Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma (lithium heparin Test Code: GGT Siemens Material Number (SMN): 11097597
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2483-2023·2023-09-06
Oculus Pentacam AXL optical devices recalled for measurement accuracy issues
Oculus Pentacam AXL optical devices with insufficient anti-reflective coating may produce incorrect axial length measurements, affecting 364 units distributed nationwide.
Product
Oculus Pentacam AXL , Ref 70100, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2472-2023·2023-09-06
Siemens Atellica CH LDL Cholesterol analyzer reagent carryover issue
Siemens is recalling Atellica CH analyzers due to potential reagent carryover that can cause falsely elevated results in cholesterol, bilirubin, and liver enzyme tests. This could affect the accuracy of patient laboratory results.
Product
Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium heparin Test Code: LDLC Siemens Material Number (SMN): 11537214
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2471-2023·2023-09-06
Laboratory diagnostic test may produce inaccurate results from reagent carryover
Siemens is recalling the Atellica CH Total Bilirubin diagnostic test because reagent carryover on the analyzer could produce falsely elevated results affecting multiple related lab tests.
Product
Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number (SMN): 11097531
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2492-2023·2023-09-06
Olympus Bronchovideoscope Model BF-Q180-AC Recalled for Lodging Risk
Olympus Corporation is recalling 416 units of the Bronchovideoscope Model BF-Q180-AC nationwide because the endoscope can become lodged in the endotracheal tube connector due to an oversized diameter.
Product
Olympus Bronchovideoscope, Model BF-Q180-AC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2487-2023·2023-09-06
Intra-Aortic Balloon Pumps Fiber Optic Sensor Input Failure Recalled
Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps because users reported failure of the fiber optic sensor input when inserting the balloon connector. This could affect proper device operation.
Product
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2486-2023·2023-09-06
Cardiosave Hybrid Intra-Aortic Balloon Pump Fiber Optic Sensor Failure
Datascope Corp. is recalling 9,379 Cardiosave Hybrid Intra-Aortic Balloon Pumps due to a fiber optic sensor failure that may occur when inserting the balloon connector.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-08
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2469-2023·2023-09-06
GS70 Salus Surgical Table may continue moving after control button release
The GS70 Salus Surgical Table may continue moving after the control button is released if communication between the control pendant and table is interrupted. This affects 110 units distributed across the US and Australia/New Zealand.
Product
GS70 Salus Surgical Table, Product Code 18-070-70
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2482-2023·2023-09-06
Medical Device Recall: Oculus Pentacam AXL Wave Measurement Inaccuracy
Oculus Pentacam AXL Wave optical devices may have insufficient anti-reflective coating, potentially causing inaccurate axial length measurements used in eye surgery planning.
Product
Oculus Pentacam AXL Wave, Ref 70020, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2493-2023·2023-09-06
Olympus Bronchovideoscope Models Recalled for Endotracheal Tube Connector Lodging Risk
Olympus is recalling 3,652 bronchovideoscope units nationwide due to complaints that the endoscope diameter is too large, creating a risk the scope may become lodged in the endotracheal tube connector.
Product
Olympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2488-2023·2023-09-06
Beckman Coulter IgA Diagnostic Reagent Recalled for Lipemic Test Interference
Beckman Coulter is recalling approximately 12,850 units of IgA diagnostic reagent due to performance failures when testing lipemic blood samples, which could lead to inaccurate test results.
Product
Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
Category
Medical Device
Distribution
42 states
HighFDA (Devices)·Z-2466-2023·2023-09-06
Medical filter barcode does not match product expiration date
Smiths Medical recalls 66,633 PORTEX 0.5u Hydrophobic Disc Filters nationwide due to a labeling error where the barcode (UDI) does not correctly reflect the product expiration date.
Product
PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2478-2023·2023-09-06
Siemens epoc BGEM Test Card recalled for glucose measurement inaccuracy
Siemens Healthcare Diagnostics is recalling epoc BGEM Test Cards for veterinary use due to potential inaccurate glucose results in lower-range samples. Affected units may report artificially elevated readings.
Product
epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Category
Medical Device
Distribution
26 states
SevereFDA (Devices)·Z-2248-2023·2023-08-30
Carina Sub-Acute Care Ventilator Recalled for Toxic Chemical Emission
Draeger Medical is recalling 11,621 Carina Sub-Acute Care Ventilators because polyurethane components emit 1,3-Dichloropropan-2-ol at levels exceeding safe limits during extended use in pediatric patients.
Product
Carina Sub-Acute Care Ventilator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2451-2023·2023-08-30
ADVIA Chemistry Urinary Protein Reagent Carryover Causing Incorrect Creatinine Results
A reagent carryover issue in Siemens ADVIA Chemistry urinary protein test kits can cause falsely low creatinine test results. The problem occurs when the creatinine test is run after the protein test on the same system.
Product
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determination of total protein in human urine and cerebrospinal fluid
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2458-2023·2023-08-30
Medicrea Cervical Fusion Implants Recalled for Packaging Defect
Medicrea International is recalling 963 PASS LP cervical fusion implants due to potential pinholes in the device packaging. The recall affects units distributed nationwide.
Product
PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B02316540Z, g) B02316545Z, h) B02316550Z, i) B02317540Z, j) B02317545Z, k) B02317550Z; intervertebral fusion device - cervical
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2440-2023·2023-08-30
FilmArray Pneumonia Panel Recalled Due to Manufacturing Defect Causing False Negatives
BioFire Diagnostics recalled FilmArray Pneumonia Panel diagnostic kits due to a manufacturing defect that may produce false negative results, potentially causing missed pneumonia diagnoses.
Product
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
Category
Medical Device
Distribution
24 states
HighFDA (Devices)·Z-2447-2023·2023-08-30
Air/Water Valve Used with Olympus Endoscopes May Malfunction
Olympus air/water valves used with ultrasonic endoscopes may fail during automated reprocessing, potentially allowing body fluids to backflow into the air channel. Approximately 29,590 units nationwide are affected.
Product
The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE: GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5, GF-UCT180, GF-UM20, GF-UM130, GF-UMQ130, GF-UM160, GF-UC160P-OL5, GF-UCT160-OL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2449-2023·2023-08-30
O-arm O2 Imaging System Ground Cable Installation Defect Recall
Medtronic is recalling O-arm O2 imaging systems due to an incorrectly installed ground cable. The defect affects 28 units distributed across the US and internationally.
Product
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm and is intended to be used where a physician benefits from 2D and 3D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2459-2023·2023-08-30
Medicrea GRANVIA-C Cervical Fusion Device Recalled for Packaging Defects
Medicrea International is recalling GRANVIA-C cervical intervertebral fusion devices due to a packaging non-conformity issue presenting as pinholes in inner or outer pouches, which could compromise sterility.
Product
GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A13131789, f)¿¿¿¿¿¿ A13132012, g)¿¿¿¿¿ B13111014, h)¿¿¿¿ B13111015, i)¿¿¿¿¿¿ B13111016, j)¿¿¿¿¿¿ B13111017, k)¿¿¿¿¿ B13111025, l)¿¿¿¿¿¿ B13111026, m
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2441-2023·2023-08-30
EMBLEM S-ICD Pulse Generator May Lose Heart Sensing for 24 Hours
Boston Scientific is recalling 3,856 EMBLEM S-ICD heart devices due to a rare interaction with the LATITUDE communicator that may disable sensing of dangerous heart rhythms for up to 24 hours.
Product
EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2439-2023·2023-08-30
BioFire Respiratory Panel 2.1 may produce false negative results
BioFire Respiratory Panel 2.1 kits for FILMARRAY systems may return false negative results due to a manufacturing defect. The recall affects 705 kits distributed to healthcare facilities in the U.S. and select international locations.
Product
BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
Category
Medical Device
Distribution
24 states
HighFDA (Devices)·Z-2448-2023·2023-08-30
FDA Recalls Randox Liquid Protein Calibrators for Measurement Accuracy Error
Randox Laboratories recalled 166 units of Liquid Protein Calibrators (IT2691) after restandardization caused Ferritin results to read approximately 10% higher than targeted calibrator values.
Product
Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferrin assays Catalogue Number: IT2691
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-2460-2023·2023-08-30
Medicrea IMPIX C+ Cervical Fusion Device Recalled for Packaging Defect
Medicrea is recalling IMPIX C+ cervical intervertebral fusion devices due to a potential packaging non-conformity that presents as a pinhole in the product pouch. The defect could affect product integrity for this implantable device.
Product
IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

7201–7225 of 27364