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.
B Braun is recalling the Infusomat Space Infusion Pump due to a sensor malfunction that can trigger false alarms, risking improper medication delivery.
Smiths Medical is recalling BLUperc and BLUselect tracheostomy tube kits worldwide due to a manufacturing defect that could cause the pilot balloon to disconnect from the inflation line, potentially compromising airway management.
Smiths Medical ASD Inc. is recalling 10,240 Pneupac paraPAC plus 310 ventilator kits due to risk of unintended tidal volume knob movement, affecting all serial numbers worldwide.
Olympus Corporation recalls 4,507 Triangle Tip Electrosurgical Knives (Model KD-640L) due to device fragmentation during use. The issue is linked to reports of serious injury and improper adherence to usage instructions.
Medline Industries is recalling medical convenience kits containing plastic syringes due to leaks, breakage, and quality defects that may pose patient health risks following an FDA Safety Alert.
Reser's American Classics Garden Pasta Salad (UPC 71117 19063) is being recalled due to potential foreign material contamination. The recall affects 278 cases distributed to nine states.
Medline Industries recalls specific lots of semi-rigid suction liners in C-section convenience kits due to reported adverse events. The liners may lose suction during intermittent use.
Siemens Healthcare is recalling ADVIA Chemistry urinary protein test reagents due to potential quality control issues that could produce inaccurate patient results.
Medtronic Xomed recalled an ENT Ultra Round Steel Cutting Bur (Model REF 31313069) because it was distributed past its expiration date. This device was distributed internationally, including to Canada.
Medline is recalling multiple convenience kits containing plastic syringes with leaks, breakage, and quality defects identified by the FDA. These defects may pose a risk to patient health.
Medline is recalling medical convenience kits containing plastic syringes due to leaks, breakage, and quality issues that may pose a risk to patient health. The recall affects multiple syringe products distributed worldwide.
Hitachi PROBEAT-FR proton therapy systems may display an insufficient number of CBCT images during 3D positioning when the Float Image Selection button is pressed, potentially affecting treatment planning accuracy.
Medline is recalling convenience kits containing plastic syringes with quality issues including leaks and breakage that may affect patient safety. The kits have been distributed worldwide.
Medline recalled medical convenience kits containing plastic syringes with leaks, breakage, and quality defects. The affected syringes may pose a risk to patient health.
Medline is recalling medical convenience kits with plastic syringes that may leak or break. The FDA issued a safety alert due to quality defects that could harm patients.
PACIFIC LASERTECH's 25-LHP-928 HeNe laser systems have a safety defect: the key control can be removed while the laser is operating. The company is replacing affected units with corrected key switches.
Medline is recalling specific lots of semi-rigid suction liners due to potential loss of suction during clinical use. The recall affects convenience kits distributed to healthcare facilities in the US, Canada, and Panama.
Yummy Monkey Organics Real Movie Theater Popcorn is recalled because the label lists butter and ghee but fails to declare milk, a major allergen. Consumers with milk allergies should not consume this product.
Medline Industries is recalling multiple convenience kits containing plastic syringes with identified quality issues including leaks and breakage. These defects may pose a risk to patient health.
Medline Industries recalls MTHZ GYN LAPAROSCOPY convenience kits with semi-rigid suction liners due to potential loss of suction during intermittent use. Affected products were manufactured between September and November 2023.
Medline Industries recalls Anesthesia Turnover Kit Pack Number DYNJAA0377 due to a non-sterile Mastisol component placed in the sterile kit without proper labeling. This poses an infection risk if users assume the component is sterile.
Medline Industries is recalling 134 units of semi-rigid suction liners due to potential loss of suction during intermittent use. The affected kits were distributed worldwide including the US, Canada, and Panama.
Medline is recalling medical convenience kits containing plastic syringes with quality defects including leaks and breakage. The kits are distributed worldwide for procedures including dialysis and spinal procedures. The defects may pose a risk to patient health.
Siemens Healthcare is recalling ADVIA Centaur CA 19-9 diagnostic test kits due to positive measurement bias in some samples. The affected kits may report falsely elevated test results, particularly around the normal limit of 35 U/mL.
Sol-Millennium Medical Inc. is recalling multiple Luer Slip Tip Syringe models because they are substantially different from FDA-approved designs and include major modifications to their intended use without approval.