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

6426–6450 of 27393

HighFDA (Devices)·Z-0682-2024·2024-01-17
ARCHITECT c4000 Processing Module recalled for unlabeled latex component
Abbott ARCHITECT c4000 Processing Module laboratory analyzers are recalled due to unlabeled dry natural rubber (latex) subcomponents. Individuals with latex allergies may experience allergic reactions if exposed to the undisclosed component.
Product
ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-0671-2024·2024-01-17
SPRYSTEP VECTOR Ankle-Foot Orthosis Recalled for Structural Failure Risk
Townsend Design is recalling the SPRYSTEP VECTOR custom ankle-foot orthosis due to potential air pockets between material layers that could cause complete structural failure. Users should stop using the device and contact the manufacturer.
Product
SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-0703-2024·2024-01-17
Diagnostic Test Kits for GI Panel May Return False Negatives Due to Manufacturing Issue
BioFire FILMARRAY GI Panel diagnostic test kits may return false negative results due to a manufacturing event, potentially leading to missed diagnoses and inappropriate treatment. The affected kits were distributed to locations in 16 U.S. states.
Product
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY 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-0683-2024·2024-01-17
Sensis Vibe Hemo Medical Device Software May Crash
Siemens is recalling 331 units of the Sensis Vibe Hemo medical device due to a potential software crash in its documentation functionality application. Units affected are distributed in California, Connecticut, and Florida.
Product
Sensis Vibe Hemo
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0694-2024·2024-01-17
SoClean 3 CPAP Cleaner Recalled Over Ozone Exposure Risk
SoClean, Inc is voluntarily recalling 40,075 units of the SoClean 3 sleep equipment cleaner due to potential ozone gas exposure. The manufacturer is providing an updated user manual with safety instructions and a protective hose and mask adapter.
Product
SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-0650-2024·2024-01-17
Abiomed Introducer Kit Sterile Barrier Compromise Risks Infection
Abiomed introducer kits may have holes in the outer pouch, compromising sterility and exposing patients to potential microbial contamination. This could lead to serious infections including bacteremia or sepsis.
Product
Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3052
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0714-2024·2024-01-17
Ambu aView 2 Monitor recalled for fire and burn hazard from oversized mounting screws
Ambu is recalling the aView 2 A Monitor due to fire and burn hazards if mounting screws longer than 16mm are used. Improper installation can penetrate the lithium-ion battery, causing fires, severe burns, and smoke inhalation.
Product
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
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-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-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-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-0713-2024·2024-01-17
Wheelchair Control Device Throttle Lever May Stick During Operation
The Scoot Control R-net wheelchair attendant controller's throttle lever may stick and fail to return to neutral, potentially causing unwanted chair movement. A total of 129 units were distributed in Tennessee and Texas.
Product
Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering a power chair
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0644-2024·2024-01-17
Olympus ENDOEYE Videoscope Recalled for Reprocessing Instructions Deviations
Olympus Corporation recalls 1,403 ENDOEYE Flex endoscopic videoscopes due to deviations in reprocessing instructions. Affected devices may not be reprocessed properly for safe reuse in surgical procedures.
Product
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within
Category
Medical Device
Distribution
Distributed nationwide
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-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-0648-2024·2024-01-17
Abiomed Oscor Introducer Kit sterile barrier holes risk infection
Abiomed Oscor Introducer Kits may have holes in the outer pouch that compromise sterility. This could allow bacteria to enter the patient's bloodstream during catheter insertion.
Product
Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3015
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
HighFDA (Devices)·Z-0653-2024·2024-01-17
Oscor Intro Catheter Introducer Kit: Compromised Sterile Barrier
Abiomed is recalling Oscor Intro Introducer Kits due to holes in the outer pouch that may compromise the sterile barrier, potentially exposing patients to harmful bacteria and infections including bacteremia and sepsis.
Product
Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3025
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0669-2024·2024-01-17
Vascu-Guard Peripheral Vascular Patch marketing materials contain inaccurate information
Baxter Healthcare is recalling marketing materials for its Vascu-Guard Peripheral Vascular Patch because a cardiovascular surgery brochure contains inaccurate content conflicting with official Instructions for Use and Prescribing Information.
Product
Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL, b) VG0110N: 1X10 CM GLOBAL, c) VG0106N: 1X6 CM GLOBAL, d) VG0209N: 2X9 CM GLOBAL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0672-2024·2024-01-17
SPRYSTEP VECTOR KAFO ankle-foot orthosis recalled for structural failure risk
The SPRYSTEP VECTOR KAFO custom ankle-foot orthosis is being recalled by Townsend Design due to air pockets that could cause complete structural failure.
Product
SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-0701-2024·2024-01-17
VADER Pedicle System Torque Wrench Recalled Due to Defective Tightening Function
Icotec is recalling VADER pedicle system torque wrenches because the torque limiting function can malfunction, potentially leaving screw fasteners insufficiently tightened during implant surgery.
Product
VADER pedicle system, torque wrench, Catalog Number 42-703
Category
Medical Device
Distribution
10 states

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6426–6450 of 27393