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

8376–8400 of 40056

HighFDA (Devices)·Z-0728-2024·2024-01-24
Ultrasound Examination Table Recall Due to Backrest Platform Stress Fracture
Oakworks Inc is recalling Ultrasound EA examination tables because the backrest platform can develop stress fractures, making the table inoperable in inclined positions. Approximately 104 units distributed nationwide are affected.
Product
Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination table
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0758-2024·2024-01-24
Maquet Volista OR Light Systems Recalled for Fall Hazard
Getinge is recalling Maquet Volista OR light systems that may fall during use in operating rooms. Approximately 236,793 units are affected nationwide and globally.
Product
Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers ROL B FOR VLT400SF STP - ARDROL309001A, ROL B FOR VLT400SF STP - ARDROL309001C, ROL B FOR VLT600SF STP - ARDROL309003A, ROL B FOR VLT600SF STP - ARDROL309003C, RO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0733-2024·2024-01-24
VACUETTE Blood Collection Tubes Missing Critical Anticoagulant Additive
VACUETTE blood collection tubes are missing an anticoagulant additive, causing samples to clot and producing inaccurate or absent lab results. This can delay diagnosis or lead to inappropriate treatment.
Product
VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0754-2024·2024-01-24
Suction Canister Liner Recalled for Loss of Suction on Low Settings
Cardinal Health Suction Canister Liners may lose suction on low or intermittent settings due to liner misalignment. Approximately 3.5 million units are affected across the US, Canada, Australia, and New Zealand.
Product
CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0746-2024·2024-01-24
Medex Injection Line Rotating Adapter Recalled Due to O-Ring Defect
Smiths Medical is recalling Medex injection line rotating adapters due to a manufacturing defect where the O-ring inner diameter may be oversized, potentially causing medication leaks during infusion.
Product
Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0726-2024·2024-01-24
PRIMA TT Shoulder Implant Baseplates Recalled for Manufacturing Defect Risk
PRIMA TT shoulder implant baseplates are being recalled by Limacorporate due to manufacturing defects in the baseplate peripheral holes that could cause the implant to loosen or the screw to move.
Product
PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM REGULAR/1975.14.800, BASEPLATE D.25MM FULL WEDGED 10-degrees/1975.14.510, BASEPLATE D.28MM FULL WEDGED 10-degrees/1975.14.810, BASEPLATE
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0734-2024·2024-01-24
FreeStyle Libre 3 App may lose signal on Android 13 devices
Abbott is recalling FreeStyle Libre 3 App on Android 13 devices due to signal loss that may prevent users from receiving glucose readings and alarms, potentially delaying necessary treatment.
Product
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0762-2024·2024-01-24
Maquet Orchide OR Light Systems recalled due to fall risk
Getinge USA is recalling Maquet Orchide OR Light Systems due to a potential for light fixtures to fall in the operating room. No injuries have been reported.
Product
Maquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD QL VP01 - ARD568803935, OHDII FHD QL AIR03 U - ARD568803952, OHDII FHD QL AIR03 E - ARD568803967, OHDII FHD QL AIR04 E/U - ARD568803968, OHDII FHD QL+ VP01 - ARD569204944, OHDII AIR03 QL FHD E - ARD56880
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0725-2024·2024-01-24
Philips Spectral CT 7500 Recalled for Multiple Software Issues Affecting Functionality
Philips is recalling 197 Spectral CT 7500 computed tomography systems due to multiple software issues affecting device functionality. The devices were distributed nationwide and internationally.
Product
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
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-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-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-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-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-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-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-0647-2024·2024-01-17
Abiomed Oscor Introducer Kit Recalled Due to Sterile Barrier Compromise
Abiomed is recalling its Oscor Introducer Kit due to holes in the outer pouch that may compromise the sterile barrier. Non-sterile introducers could expose patients to infection, bacteremia, or sepsis.
Product
Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3014
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-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-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-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-0677-2024·2024-01-17
Philips BrightView Gamma Camera System Recalled for Extremity Entrapment Hazard
Philips is recalling BrightView Gamma Camera Systems because a gap can form between patient support and detector during quality assurance scans, creating an extremity entrapment hazard that may cause fractures or crush injuries.
Product
BrightView, Gamma Camera System, Product Code 882480.
Category
Medical Device
Distribution
Distributed nationwide

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8376–8400 of 40056