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
Cardinal Health is recalling all sizes of Monoject sterile syringes—including Luer-Lock and Enteral syringes with ENFit connections—due to manufacturing and rebranding changes. Products distributed across the U.S. and Canada.
GE HealthCare is recalling EvAir compressor kits for CARESCAPE and Engström ventilators due to elevated formaldehyde levels found in preliminary testing. The recall affects 1,294 units distributed worldwide.
ROi CPS LLC is recalling 345 units of regard Operative LAP surgical convenience kits distributed in Louisiana because they were manufactured with a component that was subsequently recalled by Nurse Assist.
Megadyne Medical Products is recalling its MEGA SOFT Universal Patient Return Electrode due to reports of patient burn injuries, including third-degree burns requiring intervention. The product is now limited to use in patients age 12 and older.
Megadyne Medical Products is recalling approximately 2,312 MEGA SOFT Universal Plus Patient Return Electrodes due to reports of serious patient burn injuries, including third-degree burns. The product is now restricted to patients age 12 and older.
Megadyne Medical Products is recalling the MEGA SOFT Universal Plus Patient Return Electrode due to reports of serious burn injuries, including third-degree burns. The device should not be used in patients under 12 years old.
Nurse Assist, LLC is recalling sterile water and saline bottles across multiple brands due to potential lack of sterility assurance. The products could be nonsterile and may cause infection.
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.
Cardinal Health is recalling 1,097,048 Monoject 35 mL syringes due to demonstrated compatibility and recognition issues with infusion pumps. The affected units were distributed nationwide.
Fresenius Medical Care is recalling 703 units of the Fresenius 2008T Hemodialysis System nationwide due to potential PCBA (printed circuit board assembly) leaching from machine tubing.
Abbott Medical is recalling approximately 17,394 Proclaim DRG Implantable Pulse Generators worldwide due to reports that patients cannot exit MRI mode on affected devices. This malfunction may prevent normal device operation when mode-switching is needed.
Covidien is recalling MAHURKAR dialysis catheters because the center lumen may be blocked by excess silicone lubricant. This could delay treatment and cause blood clots, hemolysis, or embolism.
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 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.
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'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'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.
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.
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 Corp. recalls Reinforced Introducer Sets because the dilator may fracture during catheter insertion, risking arterial damage and embolization. One patient death has been reported.
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.
Olympus is recalling 17,609 bronchovideoscope units nationwide due to complaints of endobronchial combustion during therapeutic laser procedures, which poses a fire and burn risk to patients.
TELEFLEX is recalling 760 endotracheal tubes due to reports of 15mm connector disconnection. This medical device failure could compromise airway management during critical care.
Teleflex LLC is recalling 170,179 endotracheal tubes nationwide due to reports of 15mm connector disconnection. The tubes are used for airway management in medical facilities.
TELEFLEX is recalling endotracheal tubes due to reports of 15mm connector disconnection. Approximately 25,160 units were distributed nationwide.