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.
Stryker Spine is recalling 9 units of the LITe Decompression Snake Arm due to an incorrect clamp component that prevents proper attachment to the arm post shaft. Affected units were distributed in the US and internationally.
Fagron, Inc. is recalling 46 containers of Nystatin 500 MU bulk powder used for prescription compounding due to an incorrect assay value on the product label. The mislabeled strength could affect proper compounding of patient medications.
Abbott CELL-DYN Ruby and Sapphire hematology analyzers contain latex that is not labeled on the device, posing a risk to users with latex allergies. The recall affects 670 devices distributed across 33 states, Puerto Rico, and Brazil.
Karl Storz Endoscopy injection needles used in surgery may not be reliably cleaned by hand, exposing patients to higher infection risk. The recall affects 4,878 units.
Biomet's Biolox ceramic hip implant heads were shipped with the wrong adapter component. The adapter had an incorrect neck length (M/+0 instead of S/-3.0) that differs in size marking.
Fagron Inc. is recalling 9 containers of Nystatin 2 BU bulk powder because the assay value on the label is incorrect, which could affect dosing accuracy in pharmacy compounding.
Private Label Partners, Inc. recalls Selenium Sulfide 2.25% Shampoo (3,396 bottles, Lot #220551) due to stability data insufficient to support the labeled expiration date. Affected product distributed in New Jersey.
Shakespeare's Pizza recalls 7,103 units of frozen Spinach Artichoke Pizza sold in Missouri and Kansas due to undeclared wheat. Consumers with wheat allergies should not consume the product.
Biomet is recalling a hip implant adapter lot due to incorrect packaging containing the wrong adapter specification. The mismatch could result in incorrect implant selection during surgery if not detected before use.
CardioQuip is recalling the Modular Cooler-Heater (Model MCH-1000i) due to potential bacterial contamination that could cause patient infection. Four units were distributed in California, Texas, Pennsylvania, Washington, Ohio, and Nebraska.
Siemens is recalling RAPIDPoint 500 Systems Measurement Cartridges because the sodium sensor can develop a negative measurement bias that could delay diagnosis of serious electrolyte disorders or cause treatment errors.
Fagron, Inc. is recalling Nystatin 150 MU bulk powder for prescription compounding because the assay value on the label is incorrect.
Siemens is recalling RAPIDPoint 500 measurement cartridges because the sodium sensor can produce inaccurate readings, potentially leading to delayed diagnosis or incorrect treatment of electrolyte imbalances.
Karl Storz is recalling 1,127 injection needles used in general and visceral surgery because the manual cleaning process cannot be adequately assured, potentially increasing infection risk for patients.
Maquet Medical Systems USA is recalling venous probe connection cables for the Cardiohelp-i System due to insulation and wire breaks. Defective cables may prevent the system from receiving critical blood flow and temperature information.
Willamette Valley Pie Company is recalling vegan pumpkin pie products distributed in 12 states due to foreign object contamination. The voluntary recall was initiated in November 2023.
Shakespeare's Pizza Vegetarian Pizza is being recalled because it contains undeclared wheat, a common allergen. Affected products were distributed to retail stores in Missouri and Kansas and through online direct sales.
Karl Storz Endoscopy is recalling injection needles used in general and visceral surgery due to concerns that the manual cleaning process cannot ensure adequate sterilization, which may increase infection risk.
Shakespeare's Pizza is recalling 18,712 frozen pizzas due to undeclared wheat. The product was sold in retail stores in Missouri and Kansas and through online sales; consumers with wheat allergies should not consume it.
Exactech is recalling AcuMatch Hip System devices due to loss of vacuum in the inner-most vacuum bag, with 3 complaints reported affecting 4 devices. Vacuum loss could compromise device packaging integrity.
Karl Storz Endoscopy is recalling injection needles and cannulas because the manual cleaning process may not effectively remove contaminants, potentially exposing patients to infection risk.
Exactech is recalling Vantage Mobile Bearing Tibial Inserts due to loss of vacuum in the innermost vacuum bag. Three complaints involving four devices have been reported.
Exactech is recalling certain Optetrak Logic PS Knee Systems due to potential loss of vacuum in the inner-most vacuum bag. The company has received 3 complaints involving 4 devices.
Exactech is recalling specific models of its Equinoxe Shoulder System implants due to loss of vacuum in the inner-most vacuum bag. Four devices have been affected according to three complaints received.
Karl Storz Endoscopy is recalling injection needles used in general and visceral surgery because the manual cleaning process cannot be assured effective, which may expose patients to a higher risk of infection.