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

16601–16625 of 31567

SevereFDA (Drugs)·D-0108-2024·2023-11-29
Lubricating Tears Eye Drops Recalled for Non-Sterility and Bacterial Contamination
Rugby Laboratories' Lubricating Tears Eye Drops are being recalled nationwide due to non-sterility. FDA found insanitary conditions and positive bacterial test results at the manufacturing facility.
Product
Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1282-94
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0116-2024·2023-11-29
FDA Recalls Sodium Bicarbonate Injection for Silicone Particulate Contamination
Exela Pharma Sciences recalls 8.4% sodium bicarbonate injection nationwide due to silicone particulate matter in vials. The FDA classified this Class I recall as affecting 355,220 vials.
Product
SODIUM BICARBONATE — SODIUM BICARBONATE (SODIUM BICARBONATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0134-2024·2023-11-29
FDA Recalls LEADER Brand Lubricant Eye Drops Due to Non-Sterility Risk
Cardinal Health is recalling all lots of LEADER brand Lubricant Eye Drops nationwide due to non-sterility. FDA found insanitary conditions and positive bacterial test results from the manufacturing facility.
Product
LUBRICANT DROPS — LUBRICANT DROPS (CARBOXYMETHYLCELLULOSE SODIUM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0136-2024·2023-11-29
LEADER Lubricant Eye Drops Recalled for Non-Sterility and Bacterial Contamination
Cardinal Health is recalling all lots of LEADER brand Lubricant Eye Drops due to non-sterility issues. FDA found insanitary conditions and positive bacterial test results at the manufacturing facility in India.
Product
LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0587-1
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0117-2024·2023-11-29
Midazolam Injectable Recalled for Silicone Particulate Matter Contamination
Exela Pharma Sciences is recalling Midazolam Injectable due to silicone particulate matter contamination. Patients and healthcare providers with the affected lot should discontinue use and consult their healthcare provider.
Product
Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous Infusion Only Preservative Free, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial NDC 51754-2131-
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0233-2024·2023-11-29
VariSoft Infusion Set Model 1002828 Recalled for Connector Detachment Risk
The FDA recalls 1,679 VariSoft infusion sets (Model 1002828) due to connector damage that causes improper detachment. Undetected disconnections can lead to missed insulin doses and diabetic ketoacidosis.
Product
VariSoft infusion set, Model Number 1002828
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0118-2024·2023-11-29
ELCYS cysteine hydrochloride injection recalled for silicone contamination
Exela Pharma Sciences is recalling 38,200 vials of ELCYS (cysteine hydrochloride injection) nationwide due to the presence of silicone particulate matter.
Product
ELCYS — ELCYS (CYSTEINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0232-2024·2023-11-29
VariSoft Infusion Set recalled for defective connector prone to unintended disconnection
Unomedical is recalling 8,028 VariSoft infusion sets due to a manufacturing defect that makes the connector prone to unintended disconnection, potentially leading to missed insulin doses and serious blood glucose complications.
Product
VariSoft infusion set, Model Number 1002827
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0351-2024·2023-11-29
BD Extension Sets Mislabeled as DEHP-Free Despite Containing Phthalates
Certain BD Extension Sets sold as free of DEHP (di(2-ethylhexyl) phthalate) actually contain this restricted phthalate. The products have been distributed worldwide.
Product
BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog # 10013902 BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite" VALVES, Catalog
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0334-2024·2023-11-29
Gastrointestinal videoscopes recalled due to unvalidated channel drying process
Aizu Olympus is recalling 3,627 gastrointestinal videoscopes because the channel air drying process was not validated. A small percentage of devices returned after repair had wet channels, creating potential for contamination and risk of infection.
Product
Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q16
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0373-2024·2023-11-29
Biomet Compress Device Segmental Anchor Plugs Recalled for Metal Burrs
Biomet has recalled certain Compress Device Segmental Anchor Plugs (16 MM) due to metal burrs in the transverse holes. These burrs may prevent the drill or pins from passing through, potentially extending surgical time.
Product
Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178406
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-0390-2024·2023-11-29
Philips Achieva 1.5T MRI Device Recalled for Gradient Coil Fire Risk
Philips is recalling 68 Achieva 1.5T MRI machines due to potential gradient coil component failure that could produce smoke and fire. No injuries have been reported.
Product
Achieva 1.5T Conversion
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0464-2024·2023-11-29
Asenzya Hot & Spicy Cajun Style Seasoning recalled for undeclared sesame
Asenzya Hot & Spicy Cajun Style Seasoning may contain undeclared sesame allergen. The recall affects 6,930 pounds distributed in Wisconsin.
Product
Asenzya Hot & Spicy Cajun Style Seasoning, Item 121331. Net Wt 15 lbs. Distributed by: Asenzya 7616 South Sixth Street, Oak Creek, WI 53154.
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0111-2024·2023-11-29
Hand Sanitizer Recalled for Excess Acetal and Acetaldehyde Contamination
Integrity Biochem hand sanitizer recalled due to contamination with acetal and acetaldehyde at levels above FDA standards. The product was distributed to one Oklahoma distributor.
Product
Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel 208.19L (55 gallons)- drum. Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-052-03
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-0393-2024·2023-11-29
Philips MRI systems recalled for potential gradient coil fire hazard
Philips is recalling 102 Intera 1.5T MRI systems worldwide due to a potential gradient coil failure that could produce smoke and fire. The affected devices are identified by product numbers 781195 and 781295.
Product
Intera 1.5T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0361-2024·2023-11-29
Ventlab AirFlow Manual Resuscitators Recalled for CO2 Rebreathing Risk
SunMed Holdings is recalling Ventlab AirFlow manual resuscitators nationwide due to a backwards leak in the integrated manometer that allows CO2 rebreathing. Users should immediately discontinue use and contact the manufacturer.
Product
Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow Adult Resuscitator REF #s: AF1140MB-M5, AF1140MB-D5, AF5142OB, AF5142MB, AF5142MB-D235, AF1142MBP, AF5142MBP, AF5140MB, AF5140MB-2, AF5140MB-D6
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0349-2024·2023-11-29
BD Alaris Pump Infusion Sets Contain Undisclosed DEHP
BD Alaris Pump infusion sets labeled as DEHP-free actually contain di(2-ethylhexyl) phthalate. The worldwide recall affects multiple catalog numbers distributed throughout the US and internationally.
Product
BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore Tubing, Catalog # 10010483; BD AlarisTM Pump Infusion Set 1.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog # 10010453; BD Alar
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0356-2024·2023-11-29
Stryker Sage PrimaFit Female Urine Management Systems recalled for undeclared latex adhesive
Sage Products is recalling approximately 174,960 Stryker Sage PrimaFit External Urine Management Systems in three lots because a small percentage may contain tape with undeclared natural rubber latex adhesive.
Product
stryker Sage PrimaFit External Urine Management System for the Female Anatomy
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0358-2024·2023-11-29
Blood Gas Analyzer Cartridges Recalled for Potential Oxygen Measurement Errors
The FDA is recalling GEM Premier 3000 PAK cartridges manufactured by Instrumentation Laboratory because they may incorrectly report high oxygen levels in patients with low blood oxygen, potentially delaying critical treatment.
Product
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0321-2024·2023-11-29
Medtronic Mo.Ma Ultra Cerebral Protection Device Labeling Error
Medtronic is recalling 173 units of the Mo.Ma Ultra Proximal Cerebral Protection Device due to incorrect labeling that prevents proper identification of inflation and deflation ports on the device manifold.
Product
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
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-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-0363-2024·2023-11-29
Horizon manual resuscitators recalled for CO2 rebreathing hazard
SunMed Holdings is recalling Ventlab Horizon manual resuscitators due to a backwards leak in the integrated manometer that allows carbon dioxide rebreathing. The affected devices were manufactured from September 2018 to the present and distributed nationwide.
Product
Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Horizon Adult Resuscitator REF #s: 9122HZ, HZI9000, HZI9108, 9106HZ, 9110HZ, 9120HZ, 9111HZ, 9100HZ, 9105HZ, 9108HZ, 9006HZ, 9002HZ; 2. Horizon Infant Resu
Category
Medical Device
Distribution
Distributed nationwide
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

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16601–16625 of 31567