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.
Ad-Tech is recalling Spencer Probe Depth Electrodes due to an incorrect MRI safety label. The device was incorrectly labeled as MR Conditional when it is actually MR Unsafe and not cleared for MRI use.
Polymer Technology Systems recalled 2,452 A1CNow+ diabetes test systems due to mismatched cartridge and analyzer codes. Non-matching components may produce inaccurate blood glucose readings.
Fresenius Kabi Compounding recalled epinephrine 0.9% sodium chloride injections due to current good manufacturing practice violations. The recall affecting 753 bags distributed to 125 healthcare accounts was terminated on August 15, 2025.
Smiths Medical is recalling the medex TranStar Stopcock due to a manufacturing defect that can cause inaccurate pressure monitoring, interrupted pressure monitoring, or inability to zero the device.
Smiths Medical is recalling medex TranStar Kids blood sample kits due to a manufacturing defect in the pressure transducer that may cause inaccurate or interrupted pressure monitoring.
Happy Moose Juice Strawberry Field 12 oz bottles are recalled due to incomplete pasteurization affecting 1,017 units distributed across multiple states.
Medtronic Neuromodulation is recalling the SynchroMed II Infusion Pump (Product Number 8637-20) due to potential data corruption in the pump's memory that could prevent proper interrogation of the device.
Smiths Medical is recalling certain CADD Medication Cassette Reservoirs due to a weakened weld joint between the medication bag and tubing, which could result in medication leakage. No injuries have been reported.
B-K Medical A/S is recalling 1,648 ultrasound systems due to loose power connections that can cause excessive heat and potential thermal events.
Fresenius Kabi Compounding is recalling NORepinephrine Bitartrate injection due to manufacturing violations. The affected medication was distributed to 125 accounts nationwide. Healthcare providers using this product should contact their supplier.
Smiths Medical is recalling 1,640 units of medex TranStar pressure monitoring sets due to manufacturing defects in the pressure transducer that can cause inaccurate pressure readings or monitoring interruptions.
Smiths Medical ASD Inc. is recalling its Portex Y-Piece 15MM airway connector (9,133 units, worldwide) due to uncertainty in the sterile packaging seal integrity.
Smiths Medical is recalling 1110 units of the medex TranStar DPT pressure transducer due to a manufacturing defect that may cause inaccurate or interrupted pressure monitoring. The defect stems from a leak or chip failure within the device.
Baxter Healthcare Corporation is recalling the TruSystem 7000 Operating Table due to battery and connector short-circuits that can emit smoke, creating fire and electrical hazards during surgery.
BlueStar Direct LLC is recalling 50 lb. bags of dry dates due to undeclared sulfur dioxide. The product was distributed to one location in Illinois.
Medline medical procedure kits may contain non-sterile product if the breather pouch seal is opened or compromised. The recall affects 320 units distributed in the US, Canada, and Panama.
Medline is recalling certain Centurion tracheostomy kits due to potential non-sterility if the packaging seal is compromised. The affected kits may allow non-sterile product use.
Youngstown Grape Distributors is recalling Farmers Juice Focus Greens due to incomplete pasteurization, which may allow bacterial growth. Approximately 7,909 bottles with lot H240906-G are affected.
Smiths Medical is recalling the medex TranStar Neonatal Monitoring Kit due to manufacturing defects in the pressure transducer that may cause inaccurate readings or monitoring failures.
Fresenius Kabi Compounding recalled 1,008 bags of Thiamine HCl injectable due to current good manufacturing practice violations. The recall was voluntary and nationwide distribution affected 125 accounts.
Smiths Medical is recalling CADD Medication Cassette Reservoirs due to a production equipment malfunction that weakened weld joints. This could cause medication leakage.
Smiths Medical is recalling certain ENT medication reservoirs due to weakened weld joints that may cause medication leakage. Approximately 120,960 units are affected and distributed worldwide.
Medline medical procedure convenience kits with certain breather pouches may lose sterility if the vendor seal is opened. Approximately 5,972 units were distributed in the US, Canada, and Panama.
Medline is recalling certain medical procedure kits packaged in breather pouch lot 323080002 because seals may not prevent non-sterile product use. Affected units were distributed in the US, Canada, and Panama.
Olympus EZDilate Wire Guided Balloons with Lot 408987 have mislabeled sizing information. The device label states 11 mm, 12 mm, and 13 mm, but actual balloon sizes are 8.5 mm, 9.5 mm, and 10.5 mm, which may result in prolonged surgery.