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.
Merit Medical Systems is recalling Custom Procedure Kits (REF: K12T-11077) with 7F sheath introducers that are incorrectly labeled as 7.5F, a labeling discrepancy affecting 24 units distributed nationwide.
Cook Biotech recalls Biodesign Recto-Vaginal Fistula Plug RVP-0.4 units because they expire before their labeled expiration dates. Affected lots were distributed worldwide.
Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment. The recall affects 79 units distributed worldwide.
Cook Biotech is recalling 8 units of Biodesign Recto-Vaginal Fistula Plug devices because they expire before the date printed on the label. The affected products may lose sterility if used after actual expiration.
Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential for delivery catheter tip detachment during insertion.
Philips SmartPath to dStream 1.5T MRI devices may have loose assembly screws that could block the diagnostic tabletop and delay imaging. 32 units distributed worldwide.
Infla-650 Herbal Dietary Supplement is being recalled because it contains undeclared acetaminophen, diclofenac, and phenylbutazone. The product was marketed without FDA approval and poses a risk of drug interactions and adverse effects.
American Contract Systems is recalling 93 units of Endovascular AAA Packs due to inability to confirm sterilization assurance requirements were met following an environmental monitoring failure.
Cook Biotech is recalling 35 units of Biodesign Fistula Plug surgical implants that expire before their printed expiration dates, potentially compromising device function.
Ultrasonic cleaner solutions contaminated with pathogenic bacteria may cause serious infections if used in medical or dental procedures, and may leak or become bloated. Patients and healthcare workers handling the products are at risk.
American Contract Systems is recalling the PACEMAKER PACK (Lot 2405112) due to an inoperable chart recorder that prevented confirmation of sterilization requirements. Affected units were distributed in MO, MN, MA, OH, and NE.
M&P Food Products Cheese Blintzes are recalled due to undeclared wheat in the product. Consumers with wheat allergies should not consume this frozen food.
Boston Scientific has recalled AGILE and WallFlex esophageal stent systems due to potential delivery catheter tip detachment. This defect could occur during stent deployment and affect proper stent placement.
Siemens ACUSON Redwood ultrasound systems may display measurements 10 times smaller than actual if operators change the software from factory defaults to milliliters per second or minute. This could lead to misdiagnosis and poor patient management.
T.G. Eakin Limited is recalling blistered Cohesive seal ostomy barriers in Kentucky that are mislabeled with incorrect model numbers.
American Contract Systems recalls 360 units of Endovascular AAA Pack due to inability to confirm sterilization requirements were met. An inoperable chart recorder prevented verification that environmental conditions during sterilization met required specifications.
Argon Medical Devices recalls BioPince Ultra and Tru-Core II biopsy instruments due to holes in packaging trays compromising the sterile barrier, which may allow microorganism introduction and infection risk.
Centinel Spine is recalling the Prodisc C SK cervical disc implant due to blue discoloration identified as foreign contamination on the inlay during assembly. The contamination was not fully evaluated in manufacturing validations.
Skagit River Bakery & Cafe is recalling marionberry scones distributed in Washington due to undeclared soy lecithin and soybean oil on labels. Consumers with soy allergies should not consume this product.
Cook Biotech is recalling 3 units of Biodesign Recto-Vaginal Fistula Plug RVP-0.2 because the devices expire prior to the expiration date printed on the labeling.
Boston Scientific recalls WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment affecting 77 units distributed worldwide.
Philips is recalling 68 MR 5300 MRI diagnostic systems worldwide because loose screws in the RF carrier assembly could block equipment movement and delay patient diagnosis.
Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing procedures that the FDA has not reviewed or approved for safety and efficacy.
Cook Biotech is recalling the Biodesign Fistula Plug implant because devices expire before their labeled expiration dates. Thirty-nine units distributed worldwide are affected.
The FDA is recalling LINK Universal Handles due to risk of material failure when first used. The surgical instrument may break during surgery, compromising patient safety.