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.
Heartstring III Proximal Seal Systems, model HS-3045, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 126 units are affected.
Frozen AquaStar Breaded Butterfly Shrimp, clean-tail, in 3 lb packages is recalled because the product may be contaminated with Cesium-137. 126 cases are affected.
SureStep Foley Tray Systems, REF A303316A lot NGJX6399, are recalled because incorrect inserts may lead users to misidentify the catheter material or coating, risking infection or allergic reaction.
B. Braun 0.9% Sodium Chloride Irrigation USP, 3000 mL bags, is recalled for lack of assurance of sterility because port misalignment may allow fluid leakage. 16,228 bags are affected.
Bake-a-holic Cheesecake Royale Pecan Bars are recalled because a label review found milk and dairy absent from the Contains statement and soy removed from the label. 60 cases are affected.
SureStep Foley Tray Systems with Bard Lubri-Sil catheters, REF A942216 lot NGJX4320, are recalled because incorrect inserts may lead users to misidentify the catheter material or coating. 3,670 units are affected.
Bulk frozen raw half shell oysters, 15 lb, from harvest dates in January 2025 are recalled because the product is potentially contaminated with norovirus. 1,705 cases are affected.
FLEX Monoclonal Mouse Anti-Human CD20cy for Dako Omnis, catalog GA60461-2J, is recalled because of the potential for weak staining that may result in false negative CD20 identification. 67 units are affected.
Abdallah Candies Sea Salt Caramel Dark Miniature, item 2237 ML in a 5.20 lb box, is recalled for undeclared peanut and pecan. One box distributed in Pennsylvania is affected.
Zydus Entecavir Tablets, USP, 1 mg, lot E309377, are recalled nationwide after failing impurity and degradation specifications. 4,440 bottles are affected.
SureStep Foley Tray Systems, REF A303414A lot NGJY3685, are recalled because incorrect inserts may lead users to misidentify the catheter material or coating, risking infection or allergic reaction.
Sand Bar, Great American and First Street branded frozen raw shrimp in 2 pound bags is recalled because it was made under insanitary conditions and may have been contaminated with Cesium-137.
A handheld ultraviolet-C germicidal wand is recalled because it emits an unsafe level of UVC radiation, reaching the Risk Group 3 exposure limit in about 2.2 minutes and risking skin and eye injuries.
Exactech Equinoxe Reverse Shoulder humeral liners in 38 mm and 42 mm sizes are recalled because the articular surface position falls outside the dimensional specification in the labeling. 11,542 units are affected.
Best Yet, Arctic Shores and Great American branded frozen cooked shrimp is recalled because it was made under insanitary conditions and may have been contaminated with Cesium-137. 11,081 cases are affected.
UniCel DxH 900 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.
Pinnacle Radiation Therapy Planning System software is recalled because of a potential image error of the Region of Interest for expansion or contraction in head first prone, feet first supine and feet first prone orientations.
iForce Nutrition Joint Help dietary supplement, 120 capsules, lot 101330812, is recalled for unapproved drug claims. The recall covers 85,950 units across the firm's affected products.
Top Secret Nutrition Extra Strength Uric Control, 30 veggie caps, lot C1238, is recalled for unapproved drug claims. The recall covers 85,950 units across the firm's affected products.
MEDITECH Expanse Laboratory modules are recalled because entering multiple keys that trigger input simultaneously may remove data from the first field of screens or questionnaires. 148 units are affected.
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, in blisterpacks from American Health Packaging, are recalled because a micro-organism was found on a lot of packaging coil. 2,708 cartons are affected.
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, in blister cartons from American Health Packaging, are recalled because a micro-organism was found on a lot of packaging coil. 873 cartons are affected.
VITROS Chemistry Products LAC Slides from coating 0130 and above are recalled because of increased calibration failures on VITROS XT systems, delaying lactate results. 2,908 units are affected.
PrimeNutrition Phytoform Fruits & Greens Formula, 13.75 oz, lot 207460659, is recalled for unapproved drug claims and misbranding. The recall covers 85,950 units across the firm's affected products.
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, in blisterpack cartons from American Health Packaging, are recalled because a micro-organism was found on a lot of packaging coil. 1,757 cartons are affected.