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

8251–8275 of 39844

HighFDA (Devices)·Z-0764-2024·2024-01-24
Maquet Axcel Operating Room Light Systems Recalled for Fall Hazard
The FDA is recalling Maquet Axcel and Axcel+ operating room light systems due to a potential for the light system to fall. The recall affects 236,793 units distributed nationwide and globally.
Product
Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AXL 5001 - ARD567501961C, AXL 5001S - ARD567505961C, AXL 5002 - ARD567501962C, AXL 5002S - ARD567505962C, AXL 5501 - ARD567501960A, AXL 5501 - ARD567501960C, AXL 5501S - ARD567505960C, AXL+5001 DF - ARD567
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0736-2024·2024-01-24
BD PosiFlush Prefilled Saline Syringes Recalled for Incorrect Stopper
Becton Dickinson is recalling 5,085,120 BD PosiFlush Prefilled Saline Syringes due to an incorrect stopper that increases injection force and may trigger pump alarms.
Product
PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number 306547
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0737-2024·2024-01-24
V. Mueller Bandage Scissors recalled for pink dye staining on handles
Steris Corporation is recalling V. Mueller Universal Bandage Scissors (Model SU2014-001) due to an incorrect resin carrier in the handle cover. Pink dye residue may appear on scissors and sterilization pouches after processing.
Product
V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intended to cut through tape and bandages Model: SU2014-001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0699-2024·2024-01-17
Medtronic Percutaneous Pins Recalled for Potential Fitting and Removal Issues
Medtronic is recalling 4,224 REF 9733236 percutaneous pins due to a manufacturing defect that may prevent proper fitting or cause difficult removal. Affected devices were distributed worldwide.
Product
Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0678-2024·2024-01-17
Gamma Camera Gap Creates Extremity Entrapment Hazard During Quality Assurance
Philips BrightView X gamma cameras may create a gap between patient support and detector during quality assurance scans, potentially trapping a patient's extremity.
Product
BrightView X, Gamma Camera, Product Code 882478
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0652-2024·2024-01-17
Abiomed Introducer Kit Sterile Barrier Compromise Due to Pouch Defect
Abiomed Introducer Kits may have holes in outer pouches that compromise sterility, exposing patients to bacterial contamination and risk of infection, bacteremia, or sepsis.
Product
Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3046
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0700-2024·2024-01-17
VADER pedicle system torque wrench may not tighten implant screws correctly
Icotec Ag is recalling VADER pedicle system torque wrenches (Catalog Number 42-702) because the torque limiting function may malfunction, potentially leaving nut screws insufficiently tightened during implant surgery. No injuries have been reported.
Product
VADER pedicle system, torque wrench, Catalog Number 42-702
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-0705-2024·2024-01-17
Cardiac Stress Testing System may produce distorted electrocardiogram readings
The Q-Stress Cardiac Stress Testing System version 6 may distort electrocardiogram (ECG) readings when the Source Consistency Filter is enabled. Healthcare facilities should verify ECG readings and consult product documentation.
Product
Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / QS6-BXXCS: b) QS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX: c) QS6 AM12Q KIT Z200 BCRT IEC / QS-6CC-DFCXX: d) QS6 AM12Q RS SYS AHA XML / QS-6JB-AXAXA: e) QS6 AM12Q
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0704-2024·2024-01-17
BIOFIRE Respiratory Panel 2.1 recalled for false negative manufacturing defect
BioFire Diagnostics recalls 57 kits of the BIOFIRE Respiratory Panel 2.1 due to a manufacturing defect that may produce false negative results, potentially causing treatment delays or missing infections.
Product
The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch Systems.
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0679-2024·2024-01-17
Gamma Camera Recalls Due to Potential Patient Extremity Entrapment Hazard
Philips BrightView XCT gamma cameras may pose an extremity entrapment hazard during certain scanning operations. A gap can form between the patient support and detector, risking fractures, lacerations, and crush injuries.
Product
BrightView XCT, Gamma Camera, Product Code 882482
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0676-2024·2024-01-17
BD Recanalization System May Overheat or Break During Use
Bard Peripheral Vascular is recalling BD Recanalization Systems due to a manufacturing defect that may allow continuous operation without required safety warnings, increasing risk of device overheating or breaking during patient treatment.
Product
BD Recanalization System, REF: BDRECANSYSTEM
Category
Medical Device
Distribution
34 states
HighFDA (Devices)·Z-0691-2024·2024-01-17
VISERA Cysto-Nephro Videoscope Model CYF-V2: Reusable Brush Cleaning Update
Olympus is updating instructions for the VISERA Cysto-Nephro Videoscope (Model CYF-V2) nationwide, removing reusable brushes from manual cleaning procedures. Single-use brushes remain compatible.
Product
Model No. CYF-V2, VISERA Cysto-Nephro Videoscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0715-2024·2024-01-17
MRI systems at risk of unintended magnet shutdown during power loss
Philips Ingenia Ambition X and S MRI systems may experience uncontrolled shutdown of the sealed magnet if cryo-cooling is lost due to power outages. This could disrupt patient scans and operations.
Product
(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
Category
Medical Device
Distribution
24 states
HighFDA (Devices)·Z-0680-2024·2024-01-17
Abbott Alinity i Processing Module Recalled for Unlabeled Latex Subcomponent
Abbott Laboratories is recalling 1,325 Alinity i Processing Module systems due to unlabeled dry natural rubber (latex) subcomponents. Users with latex allergies may be at risk of exposure.
Product
Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology.
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-0649-2024·2024-01-17
Abiomed Introducer Kit recalled due to sterile barrier compromise risk
Abiomed is recalling Introducer Kits (part 0052-3021) with holes in the outer pouch that compromise the sterile barrier, potentially exposing patients to infection. The kits were distributed nationwide and internationally.
Product
Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Number: 0052-3021. Intended for introduction of the Impella Catheter into the body
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0711-2024·2024-01-17
Medline Surgical Gowns Recalled for Manufacturing Defect in Sleeves
Medline is recalling 2,100 Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 surgical gowns because they were manufactured with the wrong sleeve. The affected gowns were distributed to healthcare facilities in Maryland, Ohio, Tennessee, Texas, and Wisconsin.
Product
Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0689-2024·2024-01-17
Olympus Updates Manual Cleaning Instructions for Cysto-Nephro Videoscope
Olympus has updated cleaning instructions for the Model CYF-VH Cysto-Nephro Videoscope. Reusable cleaning brushes are no longer recommended for manual cleaning; single-use brushes remain compatible.
Product
Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0681-2024·2024-01-17
Abbott Alinity c Chemistry Analyzer Contains Unlabeled Latex Subcomponent
Abbott Laboratories is recalling 1,127 Alinity c Processing Module chemistry analyzers because unlabeled latex subcomponents are present. Users with latex allergies may experience serious allergic reactions upon contact.
Product
Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinit
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-0696-2024·2024-01-17
NIM TriVantage EMG Endotracheal Tubes Recalled for Loss of Nerve Monitoring
Medtronic is recalling NIM TriVantage EMG Endotracheal Tubes worldwide for noise, lead-off issues, high impedance, and loss of or intermittent nerve monitoring. The 80,569 affected units may fail to provide reliable nerve monitoring function.
Product
NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d) 8229736, 6MM ID 3PK; e) 8229737, 7MM ID 3 PK; f) 8229738, 8MM ID 3 PK
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0651-2024·2024-01-17
Abiomed Introducer Kit Recalled for Compromised Sterile Barrier
Abiomed is recalling introducer kits due to holes in the outer pouch that compromise the sterile barrier. Non-sterile product could allow microbial contamination, leading to infection such as bacteremia or sepsis.
Product
Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-0053
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0702-2024·2024-01-17
H. Pylori Diagnostic Test Recalled Due to Incorrect Expiration Date Label
Immunostics is recalling H. Pylori diagnostic test kits due to mislabeled expiration dates. Using the product after expiration may produce false positive, false negative, or invalid results.
Product
Detector H. Pylori, Catalog Number IHP-30
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0707-2024·2024-01-17
Cardiac Stress Testing Device May Produce Distorted ECG Readings
The XScribe CP Cardiac Stress Testing System (version 6) is being recalled because it may produce distorted electrocardiogram readings when the Source Consistency Filter is enabled, which could affect the accuracy of cardiac test results.
Product
XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50; b) X-SCRIBE CPI KIT WIRELESS USB 2500 MHz, 41000-030-51; c) X-SCRIBE CPI KIT DIRECT CONNECT USB, 41000-030-52; d) X-SCRIBE CPI KIT Q
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0643-2024·2024-01-17
Bard Mission Biopsy Instrument Kits Recalled for Improper Needle-Cannula Fit
Bard is recalling Mission Disposable Core Biopsy Instrument Kits due to dimensional issues that may prevent the biopsy needle from fitting properly into the cannula, potentially causing tissue injury and prolonging procedures.
Product
Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G x 16CM; 1610MSK/ Mission Kit 16G x 10CM; 1616MSK/ Mission Kit 16G x 16CM; 1810MSK/ Mission Kit 18G x 10CM; 1816MSK/ Mission Kit 18G x 16CM; 1820MSK/ Mission Ki
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0641-2024·2024-01-17
Medical diagnostic reagent recall: incorrect cell staining fluorescence
BD Biosciences is recalling CD11b APC diagnostic reagent vials that may produce dim fluorescence signals, potentially causing false negative results and misdiagnosis of blood cancers.
Product
CD11b APC: ASR, REF: 340936, and CE, REF: 333143
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0646-2024·2024-01-17
Medical Device Recall: Abiomed Axillary Insertion Introducer Sterile Barrier Breach
Abiomed Axillary Insertion Introducer Kits have holes in the outer pouch that may compromise sterility, potentially exposing patients to serious infections including bacteremia and sepsis.
Product
Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3006 Individual, and Part of Pump Set (005062, 0550-0008, 1000100, 0052-0011, 1000220)
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

8251–8275 of 39844