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 13666

HighFDA (Devices)·Z-0757-2024·2024-01-24
Maquet PowerLEDII Operating Room Light System Recalled for Fall Risk
Getinge Usa Sales Inc is recalling Maquet PowerLEDII OR light systems due to a potential for the light to fall in the operating room. No injuries have been reported.
Product
Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF - ARDPWT629100A, PWDII555DF - ARDPWT629101A, PWDII555SF - ARDPWT629102A, PWDII755DF - ARDPWT629103A, PWDII755SF - ARDPWT629104A, PWDII775DF - ARDPWT629105A, PWDII775SF - ARDPWT629106A, PWDII50DF - ARDPWT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0739-2024·2024-01-24
Medex LOGICAL CATH LAB KIT Recalled for Oversized O-Ring Defect
Smiths Medical is recalling the Medex LOGICAL CATH LAB KIT due to a manufacturing defect where the O-ring inner diameter may be oversized, affecting seal integrity and potentially leading to medication under-infusion.
Product
Medex LOGICAL CATH LAB KIT, List Number M20754
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
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-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
0 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-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
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
47 states
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-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-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-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-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-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-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-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-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-0670-2024·2024-01-17
Townsend Design Custom SPRYSTEP Ankle-Foot Orthosis Recalled for Structural Failure Risk
Townsend Design is recalling 248 units of CUSTOM SPRYSTEP ankle-foot orthotics for potential air pockets that could cause complete structural failure and loss of ankle support.
Product
CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040
Category
Medical Device
Distribution
47 states
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
47 states
HighFDA (Devices)·Z-0660-2024·2024-01-17
Baxter Preveleak Surgical Sealant recall for inaccurate marketing brochure
Baxter Healthcare has recalled a marketing brochure for its Preveleak Surgical Sealant due to inaccurate content that does not align with the product's Instructions for Use. Healthcare providers and consumers should consult the accurate product Instructions for Use and Prescribing Information.
Product
Baxter Preveleak Surgical Sealant, Product Codes: ADS201808
Category
Medical Device
Distribution
Distributed nationwide
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-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

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7551–7575 of 13666