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

7176–7200 of 27393

HighFDA (Devices)·Z-2468-2023·2023-09-06
Chevalier Valvulotome Surgical Instrument Recalled Due to Burr Defect
LeMaitre Vascular is recalling certain Chevalier Valvulotome surgical instruments used in vein-graft procedures due to burrs on the cutting tip that may tear the harvested vein. The recall affects 225 units distributed internationally.
Product
The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed bypass procedure. The Chevalier Valvulotome consists of a 70 cm stainless steel shaft with two tips: 1) the cutting tip is shaped like an invert
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2490-2023·2023-09-06
Olympus Bronchovideoscope models recalled for lodging risk in airway connectors
Olympus is recalling 1,715 Bronchovideoscope units across eight models due to a diameter defect that causes the device to lodge in the endotracheal tube connector.
Product
Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.
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
HighFDA (Devices)·Z-2474-2023·2023-09-06
Siemens Atellica CH diagnostic reagent carryover may cause false laboratory test results
Siemens has recalled 18,524 units of its Atellica CH HDL Cholesterol diagnostic device due to potential reagent carryover that could produce false test results in patient samples and quality control testing.
Product
Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium Heparin) Test Code: HDLC Siemens Material Number (SMN): 11537213
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2484-2023·2023-09-06
Oculus Myopia Master optical device recalled for insufficient anti-reflective coating
Oculus Optikgeraete GMBH is recalling 173 units of the Oculus Myopia Master optical measurement device due to insufficient anti-reflective coating that may cause incorrect axial length measurements.
Product
Oculus Myopia Master , Ref 68100, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2503-2023·2023-09-06
Olympus Bronchovideoscope Recalled for Risk of Lodging in Airway Connector
Olympus Corporation is recalling 1,004 units of the Bronchovideoscope Model BF-3C160 due to a dimensional defect that can cause the endoscope to become lodged in an endotracheal tube connector.
Product
Olympus Bronchovideoscope, Models BF-3C160.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2489-2023·2023-09-06
Upper roller bracket for Radixact gantry enclosure may lack adequate service clearance
Accuray is recalling upper roller brackets for the Radixact Treatment Delivery System because they may not provide sufficient clearance for service personnel to safely use equipment during maintenance, creating a possible injury risk.
Product
Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2475-2023·2023-09-06
LIF AMP Adjustable Awl Recalled for Assembly Defect Preventing Depth Control
Alphatec Spine is recalling the LIF AMP Adjustable Awl due to an assembly defect preventing the locking feature from engaging. This prevents proper depth control during surgery and risks dural tears, vascular injury, and neurologic damage.
Product
LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and Battalion LLIF,
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-2465-2023·2023-09-06
LifeSPARC Cardiac Pump Recalled Due to Uncured Epoxy Manufacturing Defect
Cardiac Assist, Inc. is recalling the LifeSPARC Pump due to uncured epoxy used during manufacturing that may cause early device failure. Two units were distributed in Illinois and Florida.
Product
LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TAND
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2491-2023·2023-09-06
Olympus Bronchovideoscope Models Recalled Due to Lodging Risk in Connectors
Olympus is recalling 1,072 units of Bronchovideoscope Models BF-MP160F, BF-XP160F, and BF-XP60 distributed nationwide. The devices can become lodged in the endotracheal tube connector due to oversized endoscope diameter.
Product
Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2502-2023·2023-09-06
Olympus Bronchovideoscope Recalled Due to Oversized Diameter
Olympus is recalling two models of bronchovideoscope (Models BF-3C40 and BF-N20) because the endoscope diameter is too large and may become lodged in the endotracheal tube connector.
Product
Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2500-2023·2023-09-06
Olympus Bronchovideoscope Models Risk Device Lodging in Airway
Olympus Corporation is recalling 3,949 Bronchovideoscope units nationwide because the endoscope diameter is too large, causing potential lodging in endotracheal tube connectors.
Product
Olympus Bronchovideoscope, Models BF-P190 & BF-XP190.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2499-2023·2023-09-06
Olympus Airway Mobilescope Recall Due to Connector Lodging Defect
Olympus is recalling 122 Airway Mobilescope units nationwide because the endoscope can become lodged in endotracheal tube connectors due to oversized diameter. Healthcare providers should immediately stop using affected devices.
Product
Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2496-2023·2023-09-06
Olympus Bronchovideoscope Models Recalled Due to Lodgement Risk in Connectors
Olympus is recalling 9,449 bronchovideoscope units nationwide due to complaints that the endoscope can become lodged in endotracheal tube connectors due to oversized diameter.
Product
Olympus Bronchovideoscope, Models BF-1TH190, BF-H190, BF-Q170, & BF-Q190.
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-2495-2023·2023-09-06
Olympus Airway Mobilescope models may become lodged in connectors
Olympus Airway Mobilescope endoscopes may become lodged in endotracheal tube connectors due to oversized diameter affecting airway management procedures nationwide.
Product
Olympus Airway Mobilescope, Models MAF-GM & MAF-TM.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2476-2023·2023-09-06
Siemens epoc BGEM BUN Test Card Glucose Measurement Inaccuracy Recall
Siemens Healthcare Diagnostics recalls 3,201 epoc BGEM BUN Test Cards due to potential for inaccurately high glucose readings in low-glucose samples.
Product
epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-2494-2023·2023-09-06
Olympus Bronchovideoscope Recall Due to Device Lodging Risk
Olympus is recalling Bronchovideoscope Models BF-UC180F and BF-UC190F because the device diameter is too large and can become lodged in the endotracheal tube connector. Healthcare facilities should discontinue use and contact Olympus.
Product
Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1271-2023·2023-09-06
Atellica CH Triglycerides_2 Reagent Recalled Due to Magnesium Test Interference
Siemens Healthcare Diagnostics is recalling 5,315 units of Atellica CH Triglycerides_2 diagnostic reagent due to reagent carryover that can affect magnesium test results. The product was distributed nationwide and internationally.
Product
Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglycerides in human serum and plasma (lithium heparin, sodium heparin, potassium EDTA) using the Atellica CH Analyzer. SMN: 11537222
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
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-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

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7176–7200 of 27393