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

8501–8525 of 13731

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-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-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-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-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-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-2485-2023·2023-09-06
Philips Wireless Foot Switch for X-Ray Systems Risks Loss of Function During Procedures
Philips is recalling wireless foot switches used with Allura Xper and Azurion X-ray systems because they may become unavailable during procedures. Approximately 1,865 units were distributed worldwide.
Product
Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
Category
Medical Device
Distribution
Distributed nationwide
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-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-2512-2023·2023-09-06
Phoroptor VRx Digital Refraction System head detachment hazard recall
Reichert's Phoroptor VRx Digital Refraction System head may detach from its mounting bracket and fall onto patients or operators. The recall affects 87 units distributed nationwide.
Product
PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive error of the eye. MODEL NUMBER: 16242 [Model 16241 is the base model. Model 16242 includes an additional prism feature used for the measurement of ocular deviation
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-2477-2023·2023-09-06
FDA Recalls Siemens epoc BGEM Crea Test Cards for Inaccurate Glucose Results
Siemens Healthcare is recalling epoc BGEM Crea Test Cards that may produce inaccurate glucose readings in lower-range samples. 473 units were distributed to US facilities and international locations. No injuries reported.
Product
epoc BGEM Crea 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-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-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-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-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-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-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-2504-2023·2023-09-06
Olympus Tracheal Intubation Fiberscope may lodge in endotracheal tube connector
Olympus tracheal intubation fiberscope models LF-DP, LF-GP, and LF-TP are being recalled because the endoscope can become lodged in the endotracheal tube connector due to an oversized diameter.
Product
Olympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP.
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-2481-2023·2023-09-06
Surgical Rasp Handle May Fracture Due to Weld Crack
The Link OptiStem Rasp Handle used in knee replacement surgery may develop a crack in the weld that causes the handle to fracture. If this occurs, surgical removal of the rasp must be modified, potentially prolonging the procedure.
Product
Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty surgical procedure Item Number: 17-5220/01
Category
Medical Device
Distribution
3 states
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-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-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-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

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8501–8525 of 13731