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.
Smiths Medical is recalling SurgiVet Advisor Tech Accessories due to manufacturing defects in the pressure transducer that may cause inaccurate, interrupted, or failed pressure monitoring.
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.
Medline brand medical procedure convenience kits are recalled because their packaging may allow product sterility to be compromised. The affected units were packaged in breather pouch lot 323080002.
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.
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.
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.
Spectrum Medical Ltd. is recalling 172 Quantum Perfusion Systems CPB Roller Pumps due to an out-of-tolerance ratchet and pawl defect preventing proper bobbin locking. This defect may affect blood circulation control during cardiac surgery.
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.
Shimadzu has recalled 13 Trinias unity digital angiography systems because the catheterization table may continue moving unexpectedly when the direct memory button is released during simultaneous operation with the C-arm. The operator must use the stop button to halt the table.
Medline Industries is recalling 2,740 surgical convenience kits with breather pouches that may result in non-sterile product if the vendor seal is opened. The recall affects units distributed in the US, Canada, and Panama.
Medline is recalling 160 units of EYE PACK medical procedure kits due to potential compromises in sterilization. If the vendor seal on the breather pouch is opened or unsealed, the contents may become non-sterile.
Medline is recalling 88 convenience kits used in gynecological medical procedures due to potential non-sterility if the breather pouch seal is compromised. The affected lots are distributed in the US, Canada, and Panama.
Medline is recalling 312 medical procedure convenience kits due to potential sterility issues if the breather pouch seal is opened or damaged. The affected kits were distributed in the US, Canada, and Panama.
Fresenius Kabi is recalling 1,378 bags of phenylephrine HCl injection due to manufacturing violations. The recall affects 125 healthcare facilities nationwide.
Medline is recalling certain tubal ligation procedure kits due to potential loss of sterility if the pouch seal becomes compromised during storage or handling.
Medline is recalling approximately 1,048 medical procedure convenience kits that may become non-sterile if their protective pouch seal is compromised. The affected kits were packaged with breather pouches from lot 323080002.
Smiths Medical is recalling CADD Medication Cassette Reservoirs due to a production equipment malfunction that weakened weld joints. This could cause medication leakage.
Baxter is recalling 1,077 TruSystem 7000 operating tables worldwide due to electrical short-circuits and smoke emissions in battery connectors reported by customers.
Youngstown Grape Distributors, Inc. is recalling 1,953 bottles of Farmers Juice Watermelon Hydration due to incomplete pasteurization, which may allow pathogenic bacteria to survive in the product.
Smiths Medical is recalling 385,558 units of CADD Medication Cassette Reservoirs due to a weakened weld joint that could cause medication leakage. Affected units were distributed worldwide; users should discontinue use of recalled lot numbers immediately.
Baxter Healthcare is recalling the TruSystem 7000 (dV) V operating table worldwide due to batteries and connectors that may experience electrical short-circuits and emit smoke.
Smiths Medical recalls the medex TranStar Patient Mount Monitoring Kit (1,740 units) due to manufacturing defects that may cause inaccurate or interrupted pressure monitoring.
Fresenius Kabi Compounding recalled phenylephrine HCl injectable due to cGMP violations. The recall affects 2,756 doses distributed to 125 direct accounts nationwide.
Baxter Healthcare recalled 24 units of its TruSystem 7000 operating table worldwide due to battery and connector electrical short-circuits and smoke emission.
Smiths Medical ASD Inc. is recalling the Thermovent 1200 medical device due to uncertainty in sterile packaging seal integrity. Approximately 141,196 units distributed worldwide are affected.