Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.
FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.
Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.
Teleflex LLC is recalling 11,188 endotracheal tubes due to reports of 15mm connector disconnection. The defect affects this critical airway management device nationwide.
TELEFLEX LLC is recalling 1,280 endotracheal tubes due to reports of 15mm connector disconnection. The defect could compromise airway management and poses serious safety risks during medical procedures.
TELEFLEX is recalling Preformed AGT Oral Endotracheal Tubes due to reports of the 15mm connector disconnecting from the tube. The affected product has been distributed nationwide.
TELEFLEX is recalling 5,600 endotracheal tubes nationwide due to reports of 15mm connector disconnection that could compromise airway management during patient care.
TELEFLEX LLC is recalling 3,031 Endotracheal Tube units due to reports of 15mm connector disconnection. The affected Magill model (REF 100380045) was distributed nationwide.
TELEFLEX endotracheal tubes are being recalled due to potential disconnection of the 15mm connector from the breathing tube. The disconnection could compromise respiratory support in patients.
Teleflex is recalling Slick Set endotracheal tubes due to reports of 15mm connector disconnection. The defect could prevent proper airway management during patient care.
TELEFLEX LLC is recalling Flexi-Set Cuffed Endotracheal Tube and Stylet Sets due to reports of 15mm connector disconnection. Approximately 684,042 units were distributed nationwide, including Puerto Rico.
TELEFLEX LLC is recalling Preformed AGT Oral Endotracheal Tubes due to reports of connector disconnection during use, affecting approximately 54,469 units distributed nationwide.
Teleflex LLC is recalling 1,670 Magill endotracheal tubes (REF 100380055) due to reports of 15mm connector disconnection. The Class I recall affects units distributed nationwide in the US and Puerto Rico.
TELEFLEX LLC is recalling Slick Set Cuffed Endotracheal Tube and Stylet Sets due to reports of the 15mm connector disconnecting from the tube. Approximately 4,370 units distributed nationwide including Puerto Rico are affected.
TELEFLEX LLC recalls RUSCHELIT Safety Clear Tracheal Tubes due to reports of 15mm connector disconnection. The Class I recall affects 30,391 units distributed nationwide including Puerto Rico.
TELEFLEX is recalling Preformed AGT Oral Endotracheal Tubes nationwide due to reports of the 15mm connector disconnecting from the tube, affecting 4,155 units.
TELEFLEX is recalling 3,310 units of Slick Set Uncuffed Endotracheal Tubes (REF 170155) distributed nationwide due to reports of the 15mm connector disconnecting from the tube.
Teleflex is recalling Slick Set Cuffed Endotracheal Tubes nationwide due to reported disconnection of the 15mm connector from the tube, affecting airway management in critical care settings.
Teleflex endotracheal tubes are recalled nationwide due to reported disconnection of the 15mm connector. The recall affects 1,750 units distributed across the US and Puerto Rico.
Teleflex is recalling Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection. This Class I recall affects 23,395 units distributed nationwide.
TELEFLEX is recalling approximately 8,620 Preformed AGT Oral Endotracheal Tubes distributed nationwide due to reports of disconnection of the 15mm connector from the tube.
Teleflex is recalling 14,480 Preformed AGT Oral Endotracheal Tubes nationwide due to reports of 15mm connector disconnection from the tube during use.
Teleflex endotracheal tubes are being recalled due to reports of 15mm connector disconnection. The recall affects approximately 4,110 units distributed nationwide.
Exactech Ergo Impactor Handles are recalled because the ball and spring in the locking mechanism may dislodge during disassembly or use. Approximately 784 devices are affected.
The FDA has recalled 13 LINK Endo-Model knee prosthesis femoral segments because they may not meet manufacturing specifications. The defects were discovered through customer complaints.
Cardioversion procedures can damage electronics in Vanta implantable neurostimulators, making them unresponsive. Medtronic has received two complaints resulting in device removal surgeries.
AEQUALIS FLEX REVIVE assembly screws were mislabeled during manufacturing, with some units marked as 0mm Standard actually being 0mm Short and vice versa. Surgeons must verify model numbers before use.
Compass USA is recalling Fresh To You Chicken Filet Sandwich because the chicken was not cooked. Consumers who purchased this product should not consume it.