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.
Preferred Pharmaceuticals is recalling 541 bottles of Tizanidine 4mg tablets nationwide due to failed stability specifications. Consumers with affected lot numbers should contact their pharmacist or healthcare provider.
Teleflex LLC is recalling approximately 10,650 units of Slick Set Uncuffed Endotracheal Tubes due to reports of 15mm connector disconnection from the tube.
Teleflex is recalling 18,620 endotracheal tubes due to reported disconnection of 15mm connectors. The tubes are used for oral and nasal intubation and were distributed nationwide.
TELEFLEX endotracheal tubes (Murphy design) may have a disconnected 15mm connector. Approximately 12,382 affected units were distributed nationwide. Healthcare facilities should inspect tubes before use.
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 RUSCHELIT Safety Clear Tracheal Tubes due to reported disconnection of the 15mm connector, affecting approximately 37,076 units distributed nationwide.
TELEFLEX is recalling 760 endotracheal tubes due to reports of 15mm connector disconnection. This medical device failure could compromise airway management during critical care.
The FDA is recalling 21,100 units of the MEGADYNE MEGA 2000 Patient Return Electrode due to reports of patient burns during electrosurgical procedures. All units distributed nationwide are affected.
Teleflex is recalling 25,520 Preformed AGT endotracheal tubes due to reports of 15mm connector disconnection. This is an FDA Class I recall affecting units distributed nationwide.
Teleflex LLC is recalling 2,860 endotracheal tubes due to reports of 15mm connector disconnection. Affected tubes were distributed nationwide including Puerto Rico.
TELEFLEX is recalling endotracheal tubes due to reports of 15mm connector disconnection. Approximately 25,160 units were distributed nationwide.
Teleflex Slick Set endotracheal tubes (REF 170055) are being recalled by the FDA following reports of disconnection of the 15mm connector. This Class I recall affects approximately 3,530 units distributed nationwide.
Megadyne Medical Products is recalling the MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode due to reported patient burns that occurred during electrosurgical procedures.
Megadyne Medical Products is recalling 21,100 units of MEGA SOFT Universal Plus Patient Return Electrodes used in electrosurgery. The FDA Class I recall follows reports of patient burns during surgical procedures.
TELEFLEX LLC is recalling Preformed AGT Oral Endotracheal Tubes because the 15mm connector may disconnect from the tube, creating a potential airway access risk.
TELEFLEX LLC is recalling 2,140 endotracheal tubes nationwide due to reports of the 15mm connector disconnecting from the tube. Affected units were distributed throughout the United States, including Puerto Rico.
Teleflex LLC recalls 14,780 preformed AGT oral endotracheal tubes due to reports of 15mm connector disconnection. Units were distributed nationwide.
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 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 approximately 10,600 Flexi-Set Uncuffed Endotracheal Tube and Stylet Sets due to reports that the 15mm connector may disconnect from the tube during use.
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 Tubes (REF 1700100) due to reports of the 15mm connector disconnecting from the device during use.
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 is recalling Slick Set Uncuffed Endotracheal Tubes nationwide due to reported disconnection of the 15mm connector from the tube. This disconnection could result in loss of airway during patient care.
Teleflex is recalling 14,480 Preformed AGT Oral Endotracheal Tubes nationwide due to reports of 15mm connector disconnection from the tube during use.