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

6676–6700 of 27393

HighFDA (Devices)·Z-0387-2024·2023-11-29
Biomet Compress Device Short Anchor Plug recalled for metal burrs
Biomet is recalling the Compress Device Short Anchor Plug due to metal burrs in transverse holes that may prevent proper insertion of drill or pins, potentially extending surgical time. No injuries have been reported.
Product
Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178568
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0342-2024·2023-11-29
Sigmoidovideoscope models recalled due to improper channel drying process
Aizu Olympus sigmoidovideoscope (model PCF-S) units are being recalled due to an unvalidated channel drying process. Some repaired units returned with water in channels, risking contamination and infection.
Product
Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon). Model Number: PCF-S.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0376-2024·2023-11-29
Compress Device Anchor Plugs Recalled for Metal Burrs in Surgical Holes
Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs that may prevent surgical instruments from passing through properly. The defect may result in extended surgery time.
Product
Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178412
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0325-2024·2023-11-29
IRON assay kits recalled for inaccurate diagnostic results
Sentinel CH SpA is recalling IRON assay kits (Reference Numbers 6K95-41 and 6K95-30) that may produce falsely elevated results. Affected lots could cause inaccurate iron measurements and delays in patient test reporting.
Product
IRON assay, Reference Numbers 6K95-41 and 6K95-30
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0389-2024·2023-11-29
Philips Achieva 1.5T MRI systems recalled for potential gradient coil fire risk
Philips is recalling Achieva 1.5T MRI systems due to potential gradient coil failure that could produce smoke and/or fire. Approximately 520 units have been distributed nationwide and internationally.
Product
Achieva 1.5T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0381-2024·2023-11-29
Biomet Compress Device Anchor Plugs Recalled for Metal Burrs
Biomet is recalling Compress Device Short Anchor Plugs due to metal burrs that may prevent proper surgical installation and extend operation time. Distribution includes US nationwide and eight other countries.
Product
Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178558
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0327-2024·2023-11-29
Bronchoscopes Recalled Due to Inadequate Air Drying Process
Aizu Olympus recalls bronchoscopes due to unvalidated air drying process. Some returned units after repair contain water in channels, creating infection risk.
Product
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0320-2024·2023-11-29
Medtronic Mo.Ma Ultra cerebral protection device labeling error recalled
Medtronic is recalling 2,767 units of the Mo.Ma Ultra Proximal Cerebral Protection Device due to labeling errors on the manifold that result in incorrect identification of inflation and deflation ports.
Product
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0383-2024·2023-11-29
Biomet Compress Device Anchor Plug Recalled for Metal Burrs
Biomet is recalling Compress Device Short Anchor Plugs (20 MM) because metal burrs in transverse holes prevent surgical instruments from passing through, potentially extending surgery time.
Product
Compress Device Short Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178562
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0352-2024·2023-11-29
Roche Tina-quant D-Dimer Test System Recalled for Inaccurate Results
Roche is recalling Tina-quant D-Dimer Test System kits because they produce elevated results when used with lithium-heparin plasma samples, potentially affecting diagnostic accuracy.
Product
Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0391-2024·2023-11-29
Philips Achieva 1.5T MRI Systems Recalled for Gradient Coil Fire Risk
Philips is recalling Achieva 1.5T MRI systems because the gradient coil component could fail and produce smoke or fire. The recall affects 2 units distributed worldwide.
Product
Achieva 1.5T Initial System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0341-2024·2023-11-29
Colonoscopes recalled over unvalidated channel drying process
Aizu Olympus colonoscopes are being recalled because the air drying process for the instrument channel was not properly validated. Some units returned after repair had moisture in the channel, creating a risk of contamination and infection.
Product
Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Numbers: PCF-H180AI, PCF-H180AL, PCF-H190DI, PCF-H190DL, PCF-H190I, PCF-H190L, PCF-H190TI, PCF-H190TL, PCF-HQ190I, PCF-HQ190L, PCF-PH190I
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0397-2024·2023-11-29
EXALT Model D Single-Use Duodenoscope Recalled for Lens Fluid Ingress
Boston Scientific is recalling EXALT Model D Single-Use Duodenoscopes due to fluid ingress in the lens, which causes poor image quality during procedures.
Product
EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0340-2024·2023-11-29
Mobile Airway Scope Recalled Due to Unvalidated Drying Process
Aizu Olympus has recalled 33 Mobile Airway Scope units due to an unvalidated air drying process. Some repaired units had wet channels, creating a potential risk of contamination and infection.
Product
Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: MAF-DM2, MAF-GM, MAF-GM2, MAF-TM, MAF-TM2.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0359-2024·2023-11-29
Blood Gas Analyzer Cartridges Recalled for Falsely Elevated Oxygen Readings
Instrumentation Laboratory recalls GEM Premier 3000 PAK blood gas analyzer cartridges due to measurement errors in low oxygen detection. The devices may falsely indicate normal oxygen levels when levels are dangerously low, potentially delaying treatment.
Product
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0330-2024·2023-11-29
Choleodochoscope Models Recalled Due to Unvalidated Air Drying Process
Aizu Olympus choleodochoscopes with unvalidated air drying processes may retain water in the channel after repair, risking microbial contamination and patient infection. Affected models: CHF-BP30, CHF-CB30L, CHF-P60.
Product
Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0332-2024·2023-11-29
Rhinolaryngoscope Models Recalled for Unvalidated Air Drying Process
Aizu Olympus rhinolaryngoscopes (models ENF-T3, ENF-VT2, ENF-VT3) are recalled. The air-drying process for the instrument channel was not validated, and water remaining in some devices after repair poses contamination and infection risk.
Product
Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea). Model Numbers: ENF-T3, ENF-VT2, ENF-VT3.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0372-2024·2023-11-29
Surgical Anchor Plug Devices Recalled for Potential Metal Burrs
Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs in transverse holes that may prevent surgical drill passage and extend surgery time.
Product
Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178404
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0350-2024·2023-11-29
BD Gravity Infusion Sets Labeled DEHP-Free But Contain DEHP
BD gravity blood infusion sets labeled as free of DEHP (di(2-ethylhexyl) phthalate) actually contain the substance. The recall affects products distributed worldwide through July 31, 2026.
Product
BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07T and BD GRAVITY BLOOD SET 15 DROP 180 MICRON FILTER SmartSiteTM VALVE NONVENTED, Catalog # 42081E.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0392-2024·2023-11-29
MRI Machine Gradient Coil Potential Failure Could Produce Smoke and Fire
Philips Ingenia 1.5T CX MRI systems may experience gradient coil failure that could produce smoke and/or fire. The FDA has classified this as a Class II recall affecting 48 units distributed nationwide and internationally.
Product
Ingenia 1.5T CX
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0326-2024·2023-11-29
Alinity c Iron Reagent Recalled for Falsely Elevated Test Results
The FDA is recalling Alinity c Iron Reagent lots due to inaccurate results. The reagent produces falsely elevated patient iron values and may prevent proper quality control verification.
Product
Alinity c Iron Reagent, Reference Number 08P3920
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0339-2024·2023-11-29
Tracheal Videoscope Recall Due to Unvalidated Drying Process
Aizu Olympus is recalling 61 tracheal videoscopes (Model LF-V) due to an unvalidated air drying process that left water in channels after repair. Water in the endoscope channels may become contaminated and pose an infection risk.
Product
Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Number: LF-V.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0360-2024·2023-11-29
Avanos BALLARD Closed Suction System mislabeled for DEHP content
Certain lots of AVANOS BALLARD Closed Suction System for Adults were labeled as DEHP-free but contain DEHP in tubing components. These units are used for mechanical ventilation and distributed in the US and South Africa.
Product
AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0328-2024·2023-11-29
Ultrasonic Bronchoscopes Recalled Due to Inadequate Drying Validation
Aizu Olympus is recalling 823 ultrasonic bronchoscopes (models BF-UC180F, BF-UC190F) because the channel air drying process was not validated, and some repaired units retained water that could cause contamination and infection.
Product
Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures within the airways, trancheobronchial tree, esophagus and surrounding organs Model Numbers: BF-UC180F, BF-UC190F.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0353-2024·2023-11-29
BioFire FilmArray TORCH power switch may fail from electrical arcing
BioFire FilmArray TORCH diagnostic devices have a power switch that may degrade from internal arcing and carbon buildup, potentially causing electrical short, device overheating, or failure to power on.
Product
FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports. The BioFire FilmArray Torch (BioFire Torch) is an automated in vitro diagnostic (IVD) device intended for use with FDA-cleared or ap
Category
Medical Device
Distribution
Distributed nationwide

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6676–6700 of 27393