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.
Robeson Enterprises recalls PIES & SIDES brand pumpkin pie because the product label fails to list undeclared milk and eggs, posing a risk to consumers with these allergies.
Qiagen Sciences is recalling 168 units of the EZ2 Connect MDx-IVD nucleic acid isolation device due to insufficient welding that causes heater cable embrittlement and device malfunction, resulting in sample loss during testing.
ConvaTec is recalling 63 market units of CarboFlex odor control dressings that fail to meet sterility assurance requirements. Affected lots were distributed in six states.
Lupin Pharmaceuticals recalls Rifampin Capsules USP 300mg nationwide due to subpotency—the drug contains less active ingredient than labeled. Affected lot: A201064, expiring March 2024. 26,352 bottles involved.
Teva Pharmaceuticals recalls Isotretinoin 40mg capsules for exceeding specification limits in potency. No illnesses reported.
Taylor Farms Southwest recalled 150 units of chicken caesar salad mislabeled as garden salad, with undeclared allergens including egg, fish, and soy. Affected product was distributed in Arizona, Colorado, New Mexico, Nevada, Utah, and Texas.
Synovo Production recalled 496 femoral resurfacing cup components that were marketed without FDA clearance. These hip implant components were distributed in the United States.
Robeson Enterprises is recalling its Pies & Sides squash casserole due to missing ingredient list labeling. The product contains undisclosed allergens (milk, eggs, soy, fish, wheat).
Boston Scientific is recalling 572 EndoVive PEG feeding tube kits due to a blocked lumen in the barb connector that may prevent guidewire advancement during placement, potentially requiring device exchange and increasing risk of complications.
Baxter Healthcare is recalling power cord models globally because the insulation does not meet electrical safety standards, creating a potential risk of electrical shock or fire.
Boston Scientific is recalling the EndoVive 20Fr PEG feeding kit due to blockage in the barb connector that can prevent proper placement. The blockage may lead to prolonged procedures, bleeding, gastric leakage, and aspiration risk.
Robeson Enterprises is recalling Pies & Sides Hashbrown Casserole because the label lacks an ingredient list, preventing consumers from identifying allergens. The product was distributed in Georgia, North Carolina, and South Carolina.
Baxter Healthcare is recalling Connex ProBP 3400 blood pressure monitors due to power cord insulation defects that fail to meet electrical safety standards. Approximately 11,154 units are affected globally.
PIES & SIDES Broccoli Casserole by Robeson Enterprises is recalled because the product label does not list ingredients. The product contains wheat, eggs, milk, soy, and fish.
Synovo Production is recalling 764 acetabular fixation cups marketed without FDA clearance or approval. These hip replacement components were distributed nationwide in Washington state.
Boston Scientific's EndoVive 20Fr PEG kit may have a blocked connector preventing proper guidewire advancement during placement, potentially requiring emergency intervention.
Nicomex Inc. is recalling Nicomex Tequesquite seasoning (1.5 oz) due to elevated lead levels. Approximately 192 units were distributed to retailers in New Jersey and New York.
RAJA FOODS LLC is recalling SWAD BRAND CINNAMON POWDER (3.5 oz) after testing confirmed lead contamination. The affected batch should not be consumed.
Lidl is recalling Deluxe Macarons Party Edition due to undeclared allergens. The packaging is labeled in a foreign language and does not identify wheat, soy, egg, milk, and tree nuts.
Medline is recalling certain lots of adult portable bed rails that were manufactured after the mandatory compliance date but failed to meet required safety standards, potentially posing a fall risk.
Hillrom Welch Allyn Spot Vision Screener VS100 units recalled due to power cord insulation that does not meet electrical safety standards. The affected devices may pose an electrical hazard to users.
Microbiologics Inc recalls KWIK-STIK quality control kits contaminated with Aspergillus brasiliensis fungus. Users may observe unexpected fungal growth when using affected control material.
Olympus Corporation is recalling 36 units of Hemostasis Probe Model CD-B622LA that were mispackaged with the wrong connector type and labeled incorrectly. Healthcare facilities using the wrong device could experience use errors.
Whitley Peanut Factory is recalling Deluxe Nut Mix due to undeclared allergens (peanuts, milk, soy, wheat, and sesame) not listed on the product label. Consumers with allergies should not consume this product.
Philips CT scanner software upgrade may cause the patient tabletop to move unexpectedly during scan initialization, posing collision risk to nearby operators or bystanders.