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.
Medline is recalling medical convenience kits with plastic syringes that may leak or break, posing a risk to patient health. Worldwide distribution is affected.
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 recalled medical convenience kits containing plastic syringes with leaks, breakage, and quality defects. The affected syringes may pose a risk to patient health.
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.
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.
Medline Industries is recalling medical convenience kits containing plastic syringes with quality defects including leaks and breakage. These 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.
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.
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.
Orwaiian LLC is recalling Birthday Cake Mochi Crunch due to missing allergen declarations on the label. The product contains milk and coconut but these are not listed in the Contains statement.
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 multiple convenience kits used in medical procedures due to plastic syringe defects including leaks and breakage. No injuries have been reported, but the defects may pose a risk to patient health.
Medline is recalling multiple breast biopsy convenience kits with plastic syringes affected by an FDA Safety Alert. The syringes have leaks, breakage, and quality issues that may pose a risk to patient health.
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.
Smith & Nephew is recalling 2,961 units of ROTATION MEDICAL TENDON STAPLES due to improper outer foil pouch sealing that may compromise product sterility. No injuries have been reported.
Medline is recalling medical convenience kits due to plastic syringe leaks, breakage, and quality issues that may pose a risk to patient health.
Medline is recalling multiple surgical and medical convenience kits containing plastic syringes affected by a safety alert. Leaks, breakage, and quality issues may affect patient safety during medical procedures.
Siemens is recalling Atellica IM CA 19-9 test kits (Lot 56434535) due to positive bias in measurement of tumor marker levels in some samples, particularly from Asia Pacific regions.
Medline Industries is recalling medical convenience kits containing plastic syringes due to leaks, breakage, and other quality defects that may pose a risk to patient health. Kits are distributed worldwide.
Medline is recalling vascular IVC filter placement kits containing defective plastic syringes due to leaks and breakage that may pose health risks. The affected kits are distributed worldwide.
Medline medical convenience kits containing defective plastic syringes are being recalled due to leaks, breakage, and quality issues that may harm patients. The kits were distributed worldwide and are used for invasive procedures like biopsies and lumbar punctures.
A non-sterile Mastisol component was included in certain sterile craniotomy packs without proper labeling. If users assume the component is sterile, it could increase infection risk during surgery.
Pacific LaserTech's 25-LHP-828 HeNe laser systems allow the key to be removed while operating, violating federal safety requirements. Four units distributed nationwide lack proper controls to prevent unintended laser operation.
Medline BIOPSY TRAY-LF medical convenience kits (Pack DYNDH1229, Lot 22FBA002) are recalled due to plastic syringe leaks, breakage, and quality issues that may pose risks to patient health.
Medline is recalling multiple medical convenience kits containing plastic syringes with quality issues including leaks and breakage. These kits are used for chest procedures and may pose risks to patient health.