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.
ADVIA 120/2120/2120i SETpoint Calibrator lots are being recalled because they have the incorrect platelet value assignments for ADVIA hematology systems. 2,020 units are affected.
Philips S7-3t Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.
Pitavastatin Tablets 1 mg manufactured by Orient Pharma for Teva Pharmaceuticals are being recalled because they failed impurities and degradation specifications. 20,618 bottles affected.
An interventional fluoroscopic x-ray system is being recalled because a communication failure between the dose sensor and the software may cause the system to incorrectly report a high dose.
Philips S8-3t Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.
ARTIS angiography systems are being recalled because a communication failure between the dose sensor and the software may cause the system to incorrectly report a high dose.
Onkos Surgical is recalling the My3D Personalized Solutions Humeral Cup, Model C24-0223-0003, because required inspections were not performed on finished product prior to release and distribution.
Philips Ultrasound, Inc. is recalling Philips C5-2 Transducers because they were refurbished beyond their useful life. The affected devices were distributed domestically nationwide and internationally across 49 countries.
Change Healthcare is recalling Cardiology Hemo Software (version 14.3.2 and 15.0.1) because a software update may cause the system to unexpectedly shut down. The recall affects 29 systems distributed across multiple US states and international locations.
Siemens Healthcare Diagnostics is recalling ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) units because they have incorrect platelet value assignments for the hematology systems.
Philips Ultrasound, Inc. is recalling 5,230 Philips L12-4 ultrasound transducer devices that were refurbished beyond their useful life. Affected units were distributed domestically and to numerous countries worldwide.
Ortho-Clinical Diagnostics is recalling the VITROS 5600 Integrated System due to a software anomaly that can report test results using expired reagents even when the use-expired-reagents setting is disabled, potentially causing erroneous or delayed test results.
The Harvard Drug Group LLC is recalling 23,232 cartons of Gabapentin Capsules 100 mg (Lot# M05205, Exp Date 10/2026) distributed nationwide due to inadequately sealed blister packaging that may compromise product integrity.
Philips Ultrasound, Inc. is recalling Philips XL14-3 Transducers because they were refurbished beyond their useful life, which may affect device performance and patient safety during ultrasound examinations.
AvKARE is recalling Pitavastatin 2 mg tablets nationwide due to failed impurity and degradation specifications. The affected lots do not meet quality standards for chemical purity.
Eight Valeda Light Delivery Systems are being recalled because US customers were shipped devices configured for the European Union that could not be plugged into the outlet.
Teva Pharmaceuticals is recalling Pitavastatin 2 mg tablets manufactured by Orient Pharma due to failed impurities and degradation specifications.
Thrive Health Solutions is recalling Methylcobalamin Injectable 10mg/mL pre-filled syringes (Lot #H228307, expiration 12/27/2025) due to lack of assurance of sterility. The affected product was distributed nationwide.
Hy-Vee is recalling Duo Spicy Veg Shrimp 10Pc due to potential contamination with Listeria monocytogenes. Affected product was distributed to retail locations throughout the Midwest.
Bornstein Seafoods Inc. is recalling frozen shrimp meat products after Listeria monocytogenes was detected during the firm's routine testing. The products were distributed nationwide and in Canada.
Thrive Health Solutions is recalling LX Bioboost Plus pre-filled syringes due to lack of assurance of sterility. The affected product is a multi-ingredient injectable formulation distributed nationwide.
Isabelle's Kitchen, Inc. is recalling Maple Avenue Foods Powerhouse Wheatberry Salad Kit due to Salmonella contamination. The product was distributed to Pennsylvania and Maryland.
Teva Pharmaceuticals USA, Inc. is recalling Metoclopramide Tablets, USP 10 mg due to the presence of foreign tablets or capsules in the product. The affected lot is distributed nationwide.
Hy-Vee is recalling Red Dragon Roll products due to potential contamination with Listeria monocytogenes. The recall affects 122.5 cases distributed to retail locations throughout the Midwest.
P East Trading Corp is recalling Salted Smoked Split Herring due to potential Clostridium botulinum contamination in uneviscerated fish. The product was distributed to retail locations in New York, New Jersey, and Connecticut.