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
A metal mounting box in the Incisive CT scanner may become expelled, potentially injuring users or causing the system to shut down. Philips is recalling 20 affected units distributed internationally.
Philips Azurion 7 M20 X-ray imaging systems may have loose or broken carriage support bolts and cracks in the suspension rail. The Class II recall affects 648 units distributed worldwide.
Olympus is recalling endobronchial navigation needles because an electromagnetic sensor malfunction can disable navigation guidance during medical procedures, potentially causing procedural delays.
Medline recalled 134,514 custom surgical procedural kits due to potential sterility failure in the Turkuaz Ultrasound Gel component. The affected kits were distributed worldwide from April 1, 2020 through April 28, 2023.
Datascope's LINEAR intra-aortic balloon catheters may develop a fractured introducer dilator that can injure blood vessels or cause dangerous blockages. The company has received 10 complaints including 1 death and 3 serious adverse events.
Datascope's MEGA 8Fr. intra-aortic balloon catheter introducer may fracture during insertion, leaving fragments that can damage blood vessels. The firm has reported 10 complaints, including 1 death.
Datascope TRANS-RAY IAB catheters may have introducer dilators that fracture during insertion, risking arterial damage or blood clots. The firm reports 1 death and 3 serious injuries.
The SENSATION 7 Fr. intra-aortic balloon catheter introducer dilator may fracture during insertion, potentially damaging blood vessels and requiring surgery. One death has been reported among 10 total complaints.
Datascope's MEGA 7.5Fr. intra-aortic balloon catheter kits may have introducers that fracture during insertion, risking arterial damage and embolization. The firm has received 10 complaints including 3 serious events and 1 death.
Datascope's SENSATION PLUS intra-aortic balloon catheter dilator may fracture during insertion, potentially damaging the femoral artery or aorta. The firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
Datascope Corp. recalls Reinforced Introducer Sets because the dilator may fracture during catheter insertion, risking arterial damage and embolization. One patient death has been reported.
The YAMATO PLUS intra-aortic balloon catheter's introducer dilator may fracture during insertion, risking arterial damage, aortic damage, or blood clots. Datascope has received 10 complaints, including 1 death and 3 serious adverse events.
Datascope Corp. is recalling SENSATION PLUS 8Fr. intra-aortic balloon catheters because the introducer dilator may fracture during insertion, risking blood vessel damage and surgical intervention. The company received 10 complaints, including 1 death.
FDA is recalling 399 Hamilton C2 Ventilators due to a software anomaly that may cause the device to stop unexpectedly after approximately 91 days of use. Affected facilities should verify serial numbers and contact the manufacturer.
Hamilton Medical is recalling 689 HAMILTON C1 Ventilators due to a software defect that causes unexpected shutdown after approximately 91 days of use. The device may enter ambient mode without notice, interrupting ventilatory support.
A software anomaly in the Hamilton C3 Ventilator may cause it to unexpectedly stop and enter ambient mode without warning after approximately 91 days of use. Approximately 701 systems are affected.
Hamilton Medical is recalling 2,319 HAMILTON T1 Ventilators due to a software anomaly that may cause the device to stop and enter ambient mode after approximately 91 days of use.
Qiagen's QIAstat-Dx Respiratory SARS-CoV-2 Panel diagnostic kits are recalled due to decreased performance reliability. Failed test runs could require sample retesting, potentially delaying diagnosis.
Beckman Coulter is recalling over 2 million Ringed DxI Reaction Vessels that may produce falsely elevated lab test results due to interior surface defects. The issue was discovered through internal service testing.
Davol Ventralight ST hernia repair mesh balloons may fail to inflate during surgery, potentially causing inadequate mesh placement, infection, and procedure delays.
Argon Medical Devices is recalling 3 Option Elite Retrievable Vena Cava Filters due to a potential performance defect that could result in pulmonary embolism. Affected units were distributed in Texas.
Medline Industries is recalling 9,945 DYND3000xxP Series laryngeal mask airway packs because the case and packet labels are missing expiration dates. Without this information, users cannot determine product validity.
Boston Scientific is recalling Flexiva Pulse 242 Single-Use Laser Fibers due to manufacturing defects that reduce power output and aiming beam visibility, risking fiber connector overheating and potential burns.
Davol's Ventralight ST surgical mesh may fail to inflate properly during laparoscopic hernia repair, potentially causing inadequate mesh placement and infection.
Davol's Ventralight ST hernia repair implant balloon may fail to inflate properly during laparoscopic surgery. This could result in procedure delay, inadequate mesh placement, and risk of infection.