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

3926–3950 of 27346

HighFDA (Devices)·Z-0318-2025·2024-11-13
GE Healthcare Centricity Viewer Security Vulnerability Could Allow Unauthorized Access
GE Healthcare's Centricity Universal Viewer Zero Footprint medical imaging software contains a security vulnerability that could allow unauthorized access and patient data manipulation. Approximately 120 units are affected worldwide.
Product
GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 2089507-093, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02268286, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02030900, 1495-1-Centric
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0319-2025·2024-11-13
Coated VICRYL Surgical Sutures Recalled for Needle Pull-Off and Degradation
Ethicon is recalling Coated VICRYL surgical sutures due to needle pull-off and visual degradation. Lot QP2AJM, consisting of 31,032 units, was distributed to China.
Product
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0306-2025·2024-11-13
DeRoyal C-Section Tracepack Recall Due to Stryker Smoke Evacuation Pencil Defect
DeRoyal is recalling C-Section Tracepacks containing a Stryker SafeAir Smoke Evacuation Pencil that may activate without manual input or remain active after buttons are released.
Product
DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0286-2025·2024-11-13
epoc BGEM BUN Test Cards recalled for sodium measurement bias
Siemens recalled epoc BGEM BUN Test Cards for a negative sodium bias occurring approximately 2 months before expiration, with maximum observed bias of -10 mmol/L. No adverse events reported.
Product
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0324-2025·2024-11-13
Hillrom Diagnostic Cardiology Suite Software Duplicate UID Assignment Recall
Hillrom diagnostic cardiology spirometer software may incorrectly assign duplicate identifiers to exam files, risking patient data mismatches. 1,369 units affected worldwide.
Product
Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0287-2025·2024-11-13
Surgical neurological sponges recalled for detaching X-ray markers
American Surgical Company is recalling 390 units of Americot 20-01S neurological sponges used in surgery. The X-ray detectable barium strip may detach, potentially delaying the surgical process.
Product
Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S ¿ x ¿ inches or 6mm x 6mm) Component: N/A
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0320-2025·2024-11-13
Hillrom HScribe Holter System cardiac monitoring devices duplicate identifier risk
Hillrom HScribe Holter System monitoring devices may assign duplicate file identifiers, risking patient identification mismatches in medical systems that use the identifier to match patient data to cardiac recordings.
Product
Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0285-2025·2024-11-13
Endoscopic Vessel Harvesting System Recalled for Assembly Defect
Zimmer recalls the Venapax XL endoscopic vessel harvesting system due to assembly defects that may cause endoscope interference during surgery. A Gen 5 tail piece was incorrectly assembled to Gen 4 devices, affecting 432 units nationwide.
Product
Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. Item Number: VPX4000 (7273)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0308-2025·2024-11-13
DeRoyal Children's Orthopedic Tracepack Smoke Evacuation Pencil Malfunction Recall
DeRoyal is recalling 384 units of Children's Orthopedic TracePacks containing a Stryker smoke evacuation pencil that may activate unexpectedly or fail to deactivate, posing a burn risk during surgery.
Product
DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0321-2025·2024-11-13
Cardiac stress testing system recalled due to duplicate patient identifiers
The Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System may assign duplicate unique identifiers to exam files, potentially causing patient identification mismatches with their cardiac test data.
Product
Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0289-2025·2024-11-13
Medtronic DLP Aortic Root Cannula Recalled for Potential Sterility Breach
Medtronic is recalling 420 units of DLP Aortic Root Cannulas due to a potential sterility breach caused by a misaligned seal.
Product
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0322-2025·2024-11-13
Electrocardiograph System May Assign Duplicate Identifiers to Patient Exams
The Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System may assign duplicate file identifiers that could cause patient data to be mismatched in DICOM archive systems.
Product
Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0313-2025·2024-11-13
Beckman Coulter Access Cortisol Assay Recalled for Calibration Error
Beckman Coulter is recalling 149 units of the Access Cortisol assay due to an incorrect calibration curve parameter that may cause test delays and potential injuries.
Product
The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0307-2025·2024-11-13
DeRoyal Children's Surgical Pack Recalled for Smoke Pencil Malfunction
DeRoyal is recalling certain lots of children's surgical procedure packs due to reports that the included Stryker smoke evacuation pencil may activate without manual input or remain active after buttons are released.
Product
DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0208-2025·2024-11-06
Phasitron5 breathing circuits recalled for nickel-coated spring discoloration
Percussionaire Corporation is recalling Phasitron5 breathing circuits (P5-10, P5-HC, P5-UC-10) due to discolored fluid caused by an unintended nickel coating on the spring component reacting with medicated mist. 43,830 devices have been distributed across the U.S.
Product
Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
Category
Medical Device
Distribution
40 states
SevereFDA (Devices)·Z-0092-2025·2024-11-06
VasoView HemoPro Vessel Harvesting System Recalled for Silicone Component Detachment
Maquet Cardiovascular is recalling the VasoView HemoPro Endoscopic Vessel Harvesting System due to silicone detachment from the Harvesting Tool Jaws during use. This FDA Class I recall affects 28,809 units worldwide.
Product
VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0222-2025·2024-11-06
Ambulatory Infusion System Batteries May Short Circuit and Overheat
CADD-Solis battery packs used in ambulatory infusion systems may develop internal short circuits causing battery case melting and charging circuit failure. The FDA Class I recall affects 138,039 units worldwide.
Product
CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Systems: 21-2101-0100-50, 21-2101-0200-02, 21-2101-0200-03, 21-2101-0200-06, 21-2101-0200-07, 21-2101-0200-12, 21-2101-0200-14, 21-210
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0141-2025·2024-11-06
GE Healthcare Infant Incubator Recall: Airborne Formaldehyde Off-Gassing
GE Healthcare Giraffe Incubator Carestation CS1 units may release airborne formaldehyde residue during initial use. Manufacturer notified customers in June 2023 to run incubators for one week to off-gas any residual formaldehyde, which can cause eye irritation.
Product
GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3) 2082844-002-01058424; 4) 2082844-002-01069017; 5) 2082844-002-01089666; 6) 2082844-002-01090474; 7) 2082844-002-01091269; 8) 208
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0234-2025·2024-11-06
Abbott STI and HPV Test Kits Recalled for Quality Control Failures
Abbott is recalling Alinity m STI and HPV test kits due to iron leaching that invalidates quality control checks, potentially compromising test result reliability.
Product
Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0230-2025·2024-11-06
LIFEPAK 15 Monitor/Defibrillator Recalled Due to Manufacturing Tool Defect
Physio-Control is recalling 105 LIFEPAK 15 monitor/defibrillator systems due to a manufacturing defect caused by an out-of-tolerance tool used during assembly. Affected units were distributed in Connecticut, Georgia, Massachusetts, New York, Ohio, Washington, and West Virginia.
Product
LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962 LIFEPAK 15 int
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0243-2025·2024-11-06
Surgical Patties and Strips Recalled for Endotoxin Contamination
Integra LifeSciences' surgical patties and strips (Model 801404) are being recalled due to higher-than-expected endotoxin levels that may have resulted in out-of-specification products. No illnesses have been reported.
Product
SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0279-2025·2024-11-06
Blood Oximeter Calibration Error Causes Inaccurate Oxygen Readings
The AVOXimeter 1000E blood oximeter (Serial Number 6824) has calibration values that are higher than normal, causing false oxygen level readings. This may lead to patient care mismanagement based on inaccurate data.
Product
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0268-2025·2024-11-06
Nihon Kohden Adult Ear Clip SpO2 Sensors Recalled for Lack of FDA Clearance
Nihon Kohden America Inc. is recalling 64 Adult Ear Clip SpO2 Sensors (Model 809030007) due to lack of FDA market approval and clearance for U.S. distribution.
Product
Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-0255-2025·2024-11-06
Surgical Patties and Strips Recalled for Higher Endotoxin Levels
Integra LifeSciences is recalling Surgical Patties and Strips (Model 801456) due to higher-than-expected endotoxin levels in raw materials. These surgical devices are used for tissue protection during surgery, including CNS procedures.
Product
SURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0235-2025·2024-11-06
Surgical Patties and Strips Recalled for Elevated Endotoxin Levels
Integra LifeSciences is recalling CODMAN Surgical Patties and Strips due to higher-than-expected endotoxin levels in raw material that may result in out-of-specification endotoxin in finished products.
Product
MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of COTTONOID¿ Material with x-ray detectable markers. All patties have a suture string attached for ease in performing postsurgical count verification. The surgical
Category
Medical Device
Distribution
Distributed nationwide

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3926–3950 of 27346