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.
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.
Minimum severity
Intuitive Surgical is recalling 317 units of a Da Vinci Single-Site Wristed Needle Driver due to potential dislodgement or breakage that could result in uncontrollable movement.
Aizu Olympus gastrointestinal videoscopes (GIF-H190) may have defective repairs that prevent proper sterilization, risking patient exposure to contaminated material. Affected units were distributed to medical facilities in six states.
Edwards Lifesciences is recalling 168,014 TruWave with Vamp pressure monitoring kits due to potential flushing difficulties during setup. The recall affects devices distributed across the US and internationally.
Medtronic recalled 64,739 ICM LNQ22 LINQ II insertable cardiac monitors due to potential amplified noise or signal reduction that may interfere with heart rhythm recordings.
PATH recalls SENTIERO hearing examination devices for excessive technical distortions. Affected units are distributed in FL, MO, OH, and WI.
Abbott is recalling specific lots of the Alinity m HCV AMP Kit due to reports of false positive results and reactive negative controls. The kit detects hepatitis C virus in blood samples.
Edwards Lifesciences is recalling 118,570 units of the TruWave Pressure Monitoring Set due to potential flushing difficulties during setup. The device is used for hemodynamic pressure monitoring.
EMD Millipore's Lugol's Iodine Solution (Lot 3124) is recalled due to an improper seal between the cap and bottle, which allows iodine vapors to dissipate and reduces the product's potency over time.
Edwards Lifesciences' FloTrac Sensor with Vamp System is being recalled due to potential flushing difficulties during setup of the pressure monitoring kit. No injuries have been reported.
PATH is recalling AuDX PRO hearing examination devices because they may produce technical distortions greater than expected, which could affect diagnostic accuracy. The recall affects 23 units distributed in Florida, Missouri, Ohio, and Wisconsin.
Edwards Lifesciences is recalling Acumen IQ intravascular pressure monitoring sensors (6,714 units) due to potential flushing difficulties during setup of the pressure monitoring kit.
Unomedical recalls 3,362 units of VariSoft infusion sets due to connector damage causing premature disconnection and missed insulin doses, risking dangerous elevation of blood glucose and ketone levels.
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.
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.
Aizu Olympus recalls bronchoscopes due to unvalidated air drying process. Some returned units after repair contain water in channels, creating infection risk.
SunMed's Ventlab V-Care manual resuscitators are being recalled due to a backwards leak in the integrated manometer that allows CO2 rebreathing. Affected devices were distributed nationwide.
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.
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.
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.
Aizu Olympus is recalling cystonephroscope endoscopes due to an unvalidated air drying process that allowed water to remain in instrument channels. Retained moisture poses a risk of contamination and infection.
Aizu Olympus is recalling ultrasonic gastrovideoscopes due to an unvalidated channel drying process that left some scopes with water in the channels after repair. Water remaining in the device poses a risk of contamination and infection.
Aizu Olympus is recalling uretero-reno fiberscopes because the channel air drying process was not validated. A small percentage of repaired devices had residual water in the channels, creating a risk of contamination and infection.
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.
SunMed Holdings recalls Ventlab STAT-Check manual resuscitators due to a backwards leak in the integrated manometer allowing CO2 rebreathing, which may impair ventilation. Multiple models (Adult, Infant, Pediatric) are affected and distributed nationwide.
Aizu Olympus Co., Ltd. is recalling duodenovideoscope models due to an unvalidated channel air drying process. Water remaining in the channels after repair poses a potential contamination risk that could lead to infection.