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

8426–8450 of 13652

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-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-2463-2023·2023-09-06
SurgiCount+ Surgical Sponge Counting Software Miscounting Recalled
Stryker Corporation is recalling the SurgiCount+ Software Application due to potential miscounting of surgical sponges when scanning multiple items from the same package. The software may fail to accurately track RFID-tagged absorbent articles.
Product
SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during surgical procedures Product Code: 0694-002-090;
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-1268-2023·2023-09-06
Siemens Atellica CH Analyzer: Reagent Carryover Affecting Magnesium Test Results
Siemens Healthcare Diagnostics has recalled the Atellica CH LDL Cholesterol Direct diagnostic device due to reagent carryover affecting magnesium test accuracy. Approximately 8420 units distributed nationwide and internationally are affected.
Product
Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097632
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2498-2023·2023-09-06
Olympus Bronchovideoscope Recalled Due to Lodging Risk in Airway
Olympus is recalling Bronchovideoscope Model BF-XT190 units because the device diameter is too large, causing the endoscope to become lodged in endotracheal tube connectors.
Product
Olympus Bronchovideoscope, Models BF-XT190.
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-2470-2023·2023-09-06
Skytron GS70H Surgical Table Recall: Control Failure Causes Continued Movement
The Skytron GS70H Salus Surgical Table may continue moving after the control button is released when operating in Bluetooth mode or when communication is interrupted. The defect could cause unexpected table movement during surgery.
Product
GS70H Salus Surgical Table, Product Code 18-071-70
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-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-2479-2023·2023-09-06
PASCAL Transcatheter Valve Repair System Affected by Manufacturing Defect
Edwards Lifesciences is recalling 92 units of the PASCAL Precision Transcatheter Valve Repair System due to a manufacturing defect in the release mechanism that could cause increased resistance and potential improper implant positioning.
Product
PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
Category
Medical Device
Distribution
0 states
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-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-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-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-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-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-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-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-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-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-2497-2023·2023-09-06
Olympus Bronchovideoscope Model BF-MP190F Recall for Oversized Diameter
Olympus Corporation recalls 441 Bronchovideoscope Model BF-MP190F units. The endoscope's diameter is too large, causing it to become lodged in the endotracheal tube connector.
Product
Olympus Bronchovideoscope, Models BF-MP190F.
Category
Medical Device
Distribution
Distributed nationwide
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-2464-2023·2023-09-06
Oncology Software Allergy Warnings May Not Display for Medication Ingredients
RayCare oncology software versions 5A, 5B, and 6A may fail to display medication allergy warnings under certain circumstances. Healthcare facilities could inadvertently prescribe medications patients are allergic to.
Product
RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. Model Numbers: 5.0.0, 5.0.1, 5.1.1,5.1.2,
Category
Medical Device
Distribution
Distributed nationwide
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

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8426–8450 of 13652