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.
Howmedica Osteonics is recalling the DUR PCA MTK REV INS RT knee replacement implant manufactured with UHMWPE material over 5 years old. The material can develop elevated oxidation levels that may degrade its properties.
Philips Azurion 7 M20 FlexArm systems may lose connectivity due to a date/time software issue, preventing arm and table movement. The defect affects 108 systems worldwide, including 14 in the United States.
Howmedica Osteonics is recalling knee replacement inserts manufactured with UHMWPE material over 5 years old, which may develop elevated oxidation levels that could affect joint stability.
Howmedica Osteonics Corp. is recalling knee replacement implants manufactured with UHMWPE material over 5 years old. The aged material has potential for elevated oxidation levels, which could affect the implant's material properties.
Medline is recalling specific Adult Blood Culture Kits because the expiration date of an internal Bactec component is not reflected on the kit insert, creating a risk of using an expired component.
American Contract Systems is recalling 7,881 surgical procedure kits nationwide because components were sterilized without proper validation, risking loss of functionality or elevated chemical residue.
Olympus is recalling EZDilate Fixed Wire Balloon devices used for esophageal stricture treatment due to reports of inflation/deflation failures, bursting, leaking, and foreign body retention in patients.
American Contract Systems is recalling AHN BIOPSY STERILE procedure kits nationwide because several components were improperly sterilized, potentially compromising device functionality and drug efficacy.
Golden State Medical Supply Inc. is recalling 108 bottles of Budesonide Extended-Release Tablets (9 mg) distributed in Illinois due to failed dissolution specifications.
Amerisource Health Services is recalling Rifampin 150 mg capsules because they failed to meet impurity and degradation specifications. The recall affects 1,568 cartons distributed nationwide.
Denver Solutions is recalling 12,564 bags of PHENYLephrine HCl IV solution nationwide due to a semi-automated filling system malfunction that could dispense double doses to patients.
Medline recalls Adult Blood Culture Trays due to incomplete documentation of Bactec component expiration dates on kit inserts. Users should verify the component expiration date before use.
Nestle Health Science recalled Solgar Glucosamine Chondroitin (120-tablet bottles) distributed in six states due to a packaging error where Megasorb B-Complex was filled into mislabeled bottles.
Savage Sports LLC is recalling Milk N Cookies Keto Brick due to undeclared MCT oil and acacia fiber in the formulation. Approximately 7,461 units distributed via the company's website are affected.
Medline recalls Blood Culture Kits because kit inserts fail to reflect the expiration date of included Bactec components. Users could unknowingly use expired components if they don't independently check the Bactec label.
MICROVENTION is recalling TERUMO HydroPearl Compressible Microspheres because manufacturing and quality processes were not followed during production. The recall affects 22 units distributed in seven U.S. states.
Aesculap Inc is recalling 53 JACOBSON DUROGRIP TC micro needle holders that were shipped with incorrect product labels, which may cause delays during surgical procedures.
Den-Mat Holdings recalls Hydrogen Peroxide Oral Rinse products nationwide due to manufacturing deviations that may result in products not conforming to labeled specifications.
Medline is recalling blood culture bottle kits with mismatched component expiration date documentation, creating risk of using expired components if not verified by users.
Terragene S.A. is recalling Terragene Bionova PCD (Model PCD222-C) medical devices nationwide due to a discrepancy between FDA-cleared instructions for use and the actual instructions distributed with the products.
Medline is recalling blood culture collection kits because the Bactec component expiration date is not documented on the kit insert. Users who do not check the component directly risk using an expired element.
Publix Super Markets is recalling Custom Burrito Bowls due to potential Listeria monocytogenes contamination in the shredded lettuce ingredient. The bowls were distributed in Alabama, Florida, Georgia, Kentucky, North Carolina, South Carolina, Tennessee, and Virginia during December 5-14, 2023.
Tapee Tea packaged in paper packets is being recalled because samples contain undeclared pharmaceutical substances (dexamethasone and piroxicam). The contamination poses serious health risks from unintended medication exposure.
Publix Custom Made Pizzas distributed in eight states are being recalled because the shredded lettuce ingredient may contain Listeria monocytogenes.
Publix Deli Chicken Street Tacos for Two sold in eight southeastern states are recalled due to potential Listeria monocytogenes contamination in the shredded lettuce ingredient. Consumers should not eat this product and should discard or return it.