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

16651–16675 of 31567

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-0322-2024·2023-11-29
Medtronic Mo.Ma Ultra Cerebral Protection Device manifold stickers mislabeled
Medtronic has recalled the Mo.Ma Ultra Proximal Cerebral Protection Device due to mislabeled manifold stickers. Both sides of affected units were labeled identically, potentially causing confusion about which ports control the proximal versus distal balloons.
Product
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0394-2024·2023-11-29
Intera 1.5T MRI System Recall: Gradient Coil Fire Risk
Philips is recalling the Intera 1.5T Power/Pulsar MRI system due to potential failure in the gradient coil component that could produce smoke and/or fire.
Product
Intera 1.5T Power/Pulsar
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-0337-2024·2023-11-29
Hysterofiberscope Model HYF-XP Channel Drying Process Flaw Poses Infection Risk
Aizu Olympus is recalling HYF-XP hysterofiberscopes because the channel air drying process was not validated. Some repaired units have wet channels that could harbor contamination and pose infection risk.
Product
Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0399-2024·2023-11-29
ORION Robotic Arm Recalled for Sudden Acceleration and Collision Risk
The FDA recalls ORION robotic positioning arms used in radiation and radiology due to sudden acceleration or unintended movement that could cause patient collision with treatment room equipment. No injuries reported.
Product
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0113-2024·2023-11-29
Buspirone Hydrochloride Tablets Recalled Due To Amlodipine Contamination Risk
FDA recalls Buspirone Hydrochloride 10 mg tablets due to potential contamination with foreign Amlodipine Besylate tablets. The recall affects 1,344 blister cards distributed nationwide.
Product
BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0377-2024·2023-11-29
Biomet Anchor Plugs Recalled: Metal Burrs Prevent Proper Assembly
Biomet's Compress Device Segmental Anchor Plugs are being recalled due to metal burrs in assembly holes. The defect prevents drill pins from passing through, potentially extending surgical time during implantation procedures.
Product
Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178414
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0395-2024·2023-11-29
Philips MRI Gradient Coil Recall Due to Fire and Smoke Risk
Philips is recalling SmartPath to dStream 1.5T MRI systems due to a potential gradient coil failure that could produce smoke or fire. The recall affects 119 units distributed nationwide and internationally.
Product
SmartPath to dStream for 1.5T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0378-2024·2023-11-29
Biomet Compress Device Anchor Plugs recalled for metal burrs in transverse holes
Biomet is recalling Compress Device Short Anchor Plugs due to potential metal burrs in the transverse holes that may prevent proper placement of drill pins during surgery, potentially extending surgical time.
Product
Compress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178552
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0335-2024·2023-11-29
Hysteroscope Model HYF-1T recalled due to moisture in device channels
Aizu Olympus is recalling Hysteroscope Model HYF-1T devices because the channel air drying process after repair was not validated. Some returned units had residual moisture that could allow contamination and infection.
Product
Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0364-2024·2023-11-29
RescuMed Manual Resuscitators Recalled for CO2 Rebreathing Risk
SunMed Holdings recalls RescuMed manual resuscitators due to a backwards leak in the manometer allowing CO2 rebreathing. Affected models distributed nationwide across 32 US states.
Product
Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. RescuMed Adult Resuscitator REF #s: BVM510-F, BVMB510-10, BVMB510-F, BVMB510S-F; 2. RescuMed Infant Resuscitator REF #s: BVMB710 & BVMB710-F; 3. RescuMe
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0329-2024·2023-11-29
Colonoscopes Recalled for Unvalidated Channel Drying Process and Infection Risk
Aizu Olympus is recalling certain colonoscope models because the channel air drying process was not validated. A small percentage of repaired units had water remaining in the channel, which could lead to infection risk.
Product
Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0396-2024·2023-11-29
Boston Scientific EXALT Model D Duodenoscope Recall: Fluid Ingress in Lens
Boston Scientific is recalling certain EXALT Model D Single-Use Duodenoscopes worldwide due to fluid ingress in the lens, which causes poor image quality. Affected devices should not be used; contact the manufacturer.
Product
EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0388-2024·2023-11-29
Biomet Compress Device Short Anchor Plug recalled due to metal burrs
Biomet is recalling Compress Device Short Anchor Plugs (28 MM, Item 178570) due to potential metal burrs in transverse holes that may prevent surgical instruments from passing through, extending surgery duration.
Product
Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178570
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-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-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-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-0336-2024·2023-11-29
Hysterovideoscope Models Recalled Due to Improper Channel Drying Risk
Aizu Olympus is recalling Hysterovideoscope Model HYF-V units (27 devices) because the channel air drying process was not validated. Water remaining in device channels could pose an infection risk.
Product
Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0110-2024·2023-11-29
Hand Sanitizer Recalled for Chemical Contamination Above Specifications
Integrity Biochem 70% alcohol hand sanitizer recalled due to acetal and acetaldehyde contamination above USP limits. The 55-gallon drums distributed in Oklahoma may not meet safety standards.
Product
Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topical Gel 208.19L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-047-03
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-0362-2024·2023-11-29
BreathTech Manual Resuscitators Recalled for Integrated Manometer Leak
SunMed Holdings is recalling BreathTech manual resuscitators because the integrated manometer can leak, allowing patients to rebreathe exhaled CO2 during emergency airway management.
Product
Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. BreathTech Adult Resuscitator REF #s: BT5107F & BT5104P; 2. BreathTech Child Resuscitator REF #s: BT3030, BT3034, & BT3025; 3. BreathTech Infant Res
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-0338-2024·2023-11-29
Tracheal Fiberscope Airway Management Devices Recalled for Inadequate Channel Drying
Aizu Olympus is recalling 65 tracheal fiberscope units worldwide due to an unvalidated air drying process. Moisture remaining in device channels after repair could allow contamination and pose an infection risk.
Product
Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: LF-DP, LF-GP, LF-TP.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0465-2024·2023-11-29
Jeni's Splendid Ice Cream Recalled for Aluminum and Steel Contamination
Jeni's Splendid Ice Cream Buttercream Birthday Cake is recalled for potential aluminum and stainless steel pieces in the product. Consumers should stop consuming and return all affected packages.
Product
Jeni's Splendid Ice Cream: Buttercream Birthday Cake Ice Cream packaged in paperboard pint cups with heat seals and paper lids - 8 pints per case
Category
Food
Distribution
0 states

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