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.
Dr. Reddy's Laboratories is recalling 31,802 bottles of IBU Ibuprofen 600mg tablets due to failed impurity specifications. The product was distributed nationwide and in Puerto Rico.
CVS Health and HEB Baby Premium Infant Formula with Iron is recalled due to vitamin D levels exceeding permitted maximums. The recall affects 16,500 units.
Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes. The voluntary recall affects approximately 1,629 units distributed nationwide.
Stryker has recalled 1171 units of iBur 5.0mm surgical burs due to potential overheating at the bur shank junction. The overheating could cause thermal injury requiring medical intervention.
Medline Industries recalls Centurion breast biopsy procedure kits due to defective plastic syringes that may leak or break. The syringes are affected by an FDA safety alert and pose potential risks during medical procedures.
Medline is recalling procedure packs containing Shenli syringes due to leaks, breakage, and quality issues that may pose risks to patient health. Over 1.6 million units have been distributed worldwide.
Medline is recalling Centurion procedure packs with plastic syringes that have leaks, breakage, and other quality issues. These defects may pose a risk to patient health.
Medline Industries recalled procedure packs containing Shenli syringes due to leaks, breakage, and quality defects. The recalled units were distributed worldwide and may pose a risk to patient health.
GE Healthcare's Proteus XR/a stationary X-ray system lacks a required de-installation manual, creating risk of personnel injury during device removal.
Medline is recalling Preop Nerve Block Tray kits worldwide due to plastic syringes with leaks, breakage, and quality defects. These defects were identified in an FDA safety alert and may pose risks to patient health.
Medline Industries recalls 1,679,067 medical convenience kits containing plastic syringes that may leak or break, posing potential risks to patient health.
Intuitive Surgical is recalling the Ion Endoluminal System due to potential screw failure in the instrument cart arm, which could cause uncontrolled catheter motion in patient airways.
ALB Flavor cinnamon powder is recalled due to elevated lead contamination. The product was distributed in NY, CT, MI, and MA and poses a serious health risk.
Dr. Reddy's Laboratories is recalling IBU (Ibuprofen) 800 mg prescription tablets nationwide due to failed quality specifications. Testing found unknown impurities exceeding acceptable limits.
Medline is recalling three procedural kits containing plastic syringes with leaks and breakage issues that may pose a risk to patient health. The kits have been distributed worldwide.
Medline Industries is recalling multiple surgical procedural kits containing plastic syringes with quality defects. The syringes may leak or break during use, posing a risk to patient safety.
Gutierrez Distributors recalls ground cinnamon products (El Servidor Corp and Canela Molida brands) due to elevated lead levels. Consumers who purchased these products should not use them.
Medline procedural kits containing defective plastic syringes have been recalled worldwide due to potential leaks and breakage. The affected products include ultrasound catheter insertion and circumcision kits distributed globally.
Medline Industries is recalling Centurion procedure kits due to plastic syringes with defects including leaks and breakage. These defects may compromise patient safety during medical procedures.
Stryker iBur 3.0mm Diamond Match Head surgical cutting tools may reach temperatures exceeding safe operating limits during bone surgery, potentially causing thermal tissue injury. About 2,507 units worldwide are affected.
La Superior Bakery is recalling Pan Guatemalteco pastries due to undeclared sesame seeds. Consumers with sesame allergies face risk of allergic reaction.
Multiple Medline procedural kits contain defective plastic syringes that may leak or break during medical procedures. The FDA has advised of potential patient health risks from these manufacturing quality issues.
Medline is recalling medical procedure packs containing Shenli syringes due to identified leaks, breakage, and quality issues. These kits may pose a risk to patient health during surgical procedures.
A software issue in DxI 9000 Access analyzers connected to laboratory automation systems may prevent processing of all samples, flagging tests as timed out and potentially delaying patient results.
Medline procedural kits contain plastic syringes affected by an FDA Safety Alert. The syringes may leak or break, posing risks to patients during medical procedures.