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

7551–7575 of 13683

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-0697-2024·2024-01-17
Olympus ENDOEYE HD II Videoscope Image Discoloration Recall
Two Olympus ENDOEYE HD II Rigid Videoscope catalog numbers (WA50040A, WA50042A) have been recalled due to reports of pink or green image discoloration during use. The issue could require device exchange during surgery and potentially result in visual impacts or bleeding.
Product
Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -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 the tho
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0698-2024·2024-01-17
Medtronic Percutaneous Surgical Pins Recalled Due to Potential Fitting Defects
Medtronic is recalling 4,235 percutaneous surgical pins that may have a manufacturing defect preventing proper fit into or removal from the tap cap. The pins were distributed nationwide and internationally.
Product
Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
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-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-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-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-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
0 states
HighFDA (Devices)·Z-0706-2024·2024-01-17
XScribe Cardiac Stress Testing System may distort ECG readings
Baxter Healthcare Corporation is recalling 2,985 units of the XScribe Cardiac Stress Testing System, version 6, due to potential distortion in electrocardiogram readings when the Source Consistency Filter is enabled. No injuries have been reported.
Product
XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX; b) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-DXXXX; c) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-XXXXX; d) XS6 WAM TTL KIT IEC XML BRAZIL, XSCRIBE-5AX-XXBRZ; e) XS6
Category
Medical Device
Distribution
0 states
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-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-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-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-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
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-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-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-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-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
47 states
HighFDA (Devices)·Z-0654-2024·2024-01-17
Abiomed Introducer Kits recalled due to sterile barrier compromise
Abiomed is recalling Introducer Kits because holes in the outer pouch may compromise the sterile barrier, risking bacterial infection. The kits are distributed nationwide and internationally.
Product
Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3056
Category
Medical Device
Distribution
Distributed nationwide
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
47 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-0655-2024·2024-01-17
Abiomed Introducer Kits Recalled for Sterile Barrier Pouch Defect
Abiomed is recalling 84 introducer kits that may have holes in the outer pouch, compromising the sterile barrier. This exposes patients to microbial contamination and risk of serious infections including bacteremia and sepsis.
Product
Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 2000342
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-0645-2024·2024-01-17
Olympus ENDOEYE Flex Videoscope Recalled for Reprocessing Instruction Deviations
Olympus Corporation is recalling 271 ENDOEYE Flex Deflectable Videoscopes due to deviations in reprocessing instructions. Proper sterilization procedures are critical for safe endoscopic use.
Product
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 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 t
Category
Medical Device
Distribution
Distributed nationwide

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7551–7575 of 13683