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 is recalling Slick Set Uncuffed Endotracheal Tube kits due to reports of 15mm connector disconnection. 20,662 units have been distributed nationwide, including Puerto Rico.
Megadyne Medical Products is recalling MEGA SOFT Universal Patient Return Electrodes after reports of patient burns during electrosurgery procedures. The FDA classified this as a Class I recall.
Megadyne Medical Products is recalling 21,100 MEGADYNE MEGA SOFT Reusable Patient Return Electrodes nationwide due to reports of patient burns during electrosurgical procedures.
TELEFLEX LLC is recalling Flexi-Set Cuffed Endotracheal Tube and Stylet Sets nationwide due to reports of the 15mm connector disconnecting from the tube, posing a serious risk in critical care settings.
TELEFLEX LLC is recalling 13,710 units of Flexi-Set Cuffed Endotracheal Tubes due to reports of connector disconnection. The 15mm connector may separate from the tube during use.
Flexi-Set Cuffed Endotracheal Tube kits are being recalled due to reports of the 15mm connector disconnecting from the tube. Affected units were distributed nationwide.
Teleflex is recalling 510 units of Slick Set Endotracheal Tubes with reported connector disconnection issues. The defect may prevent proper airway management during critical medical use.
Teleflex is recalling Slick Set Cuffed Endotracheal Tubes because the 15mm connector may disconnect from the tube. The recall affects 1,460 units distributed nationwide, including Puerto Rico.
TELEFLEX is recalling 2,382 Slick Set Uncuffed Endotracheal Tubes due to reports of 15mm connector disconnection. Units were distributed nationwide including Puerto Rico.
TELEFLEX LLC recalls Flexi-Set Uncuffed Endotracheal Tube and Stylet Sets due to reports of the 15mm connector disconnecting from the tube. Approximately 16,400 units distributed nationwide are affected.
TELEFLEX LLC is recalling RUSCHELIT Safety Clear Tracheal Tubes due to reports of 15mm connector disconnection. The recall involves 21,284 units distributed nationwide.
Megadyne Medical Products is recalling the MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode used in electrosurgery due to reports of patient burns during surgical procedures.
Teleflex is recalling 4,769 endotracheal tubes due to reports of 15mm connector disconnection. This defect could interrupt breathing support during airway management procedures.
Teleflex is recalling Flexi-Set Cuffed Endotracheal Tube Sets due to reported 15mm connector disconnection. The recall affects 92,930 units distributed throughout the United States, including Puerto Rico.
Teleflex is recalling 20,042 endotracheal tubes due to reports of 15mm connector disconnection that could compromise airway management. The FDA classified this as a Class I recall.
TELEFLEX LLC is recalling 9,070 Preformed AGT Oral Endotracheal Tubes nationwide due to reports of 15mm connector disconnection. This medical device is used for airway management in hospital settings.
Teleflex is recalling 35,513 preformed AGT oral endotracheal tubes nationwide due to reported connector disconnection from the 15mm tube connector.
Teleflex LLC is recalling Preformed AGT Oral Endotracheal Tubes due to reported connector disconnections. The recall affects 24,752 units distributed nationwide, including Puerto Rico.
Teleflex LLC is recalling 17,102 Endotracheal Tubes (REF 100382040) following reports of disconnection of the 15mm connector from the tube. The affected units were distributed nationwide, including Puerto Rico.
Teleflex endotracheal tubes with high-volume, low-pressure cuffs are recalled due to reports of 15mm connector disconnection. The recall affects 13,810 units distributed nationwide.
TELEFLEX is recalling 2,874 Preformed AGT Oral Endotracheal Tubes nationwide due to reports of the 15mm connector disconnecting from the tube. Affected users should immediately discontinue use.
The FDA is recalling approximately 302,652 Teleflex preformed oral endotracheal tubes nationwide due to reports of disconnection between the 15mm connector and the tube. Healthcare providers should immediately discontinue use of affected units.
Teleflex recalls 76,060 preformed oral endotracheal tubes due to reports of 15mm connector disconnection. A disconnected connector could compromise ventilation in critical care settings.
Teleflex is recalling 17,551 units of Flexi-Set Uncuffed Endotracheal Tubes nationwide after reports of the 15mm connector disconnecting from the tube.
Richin Trading Inc is recalling Sun Wave Brand Mango Jelly Cups due to a potential choking hazard. The recall affects 141,192 units distributed across 17 states.