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.
Universal Meditech Inc. is recalling HealthyWiser UriTest™ UTI Test Strips due to missing documentation of Quality System compliance. The manufacturer is going out of business and cannot fulfill post-market safety obligations.
Biomic Sciences is recalling Restore Sinus Spray due to microbial contamination of the non-sterile product. The product is distributed nationwide and internationally.
Universal Meditech Inc. is recalling multiple diagnostic test kits distributed without FDA authorization. The firm is closing operations and cannot verify Quality System compliance or provide post-market support.
Universal Meditech is recalling DiagnosUS hCG pregnancy test cassettes distributed without proper FDA authorization and quality documentation. The company is closing and cannot provide manufacturing records or post-market surveillance data.
American Contract Systems recalled 1260 units of Cath Cardiac Pack due to improper sterilization exposure that may cause loss of functionality or higher ethylene oxide residuals.
Smiths Medical is recalling 31,900 Portex Pro-Vent Arterial Blood Sampling Kits due to missing filter components. Kits without the filter can produce inaccurate test results or expose users to infectious blood.
Medtronic is recalling Grafton Plus DBM Paste due to a missed inspection step on the outer packaging. The outer Tyvek pouch may have non-conformances that could affect product integrity.
American Contract Systems is recalling its Robotics Pack (56 cases) due to improper sterilization of IV catheter and adhesive components. The devices may have lost functionality or drug efficacy and may contain excessive ethylene oxide residuals.
American Contract Systems is recalling Pediatric Urology Wolson Packs due to components being exposed to unapproved sterilization processes. Components may have lost functionality or reduced efficacy, potentially compromising device performance.
Biomic Sciences is recalling all lots of ION Sinus Support Nasal Spray due to microbial contamination. The product has been distributed nationwide and internationally.
Smith & Nephew is recalling 29 units of a knee prosthesis component due to labeling and packaging errors where two product types were swapped during manufacturing.
Universal Meditech Inc. is recalling PrestiBio Ketone Test Strips because they were distributed without FDA marketing authorization. The company is going out of business and cannot provide post-market support.
American Contract Systems is recalling LAVH surgical component kits because two components were subjected to improper sterilization temperatures and ethylene oxide exposure, potentially causing loss of functionality and higher chemical residuals.
Medtronic is recalling Grafton DBM Crunch bone matrix surgical implants due to potential packaging defects in the outer Tyvek pouch. An inspection step may not have been completed according to requirements.
FDA is recalling DiagnosUS Ovulation Test Strips from Universal Meditech Inc. because the manufacturer cannot document that the devices were made according to quality standards. The company is ceasing operations and cannot fulfill post-market obligations.
Penzeys, Ltd. is recalling Brady Street Cheese Sprinkle because it may contain sesame, which is not declared on the label. People with sesame allergies should not consume this product.
Medtronic Sofamor Danek USA Inc is recalling specific batches of Grafton DBM Orthoblend, an orthopedic implant material, because a required sterile packaging inspection step may not have been performed according to specifications.
SynCardia Systems is recalling 114 units of the SynCardia 50cc TAH-t artificial heart because it contains an epoxy resin that has not been reviewed by the FDA for safety and efficacy.
Universal Meditech recalled 147,000 pregnancy tests lacking verified FDA clearance and quality documentation. The manufacturer is closing and cannot support post-market safety surveillance.
Preat Corp is recalling 23 Neodent GM x 4mm Healing Abutments due to a dimensional defect that may allow microleakage between the abutment and implant. Affected units were distributed to dental practices in multiple US states.
Universal Meditech Inc. is recalling HealthyWiser pH-Aware pH Test Strips because the manufacturer lacks documentation verifying manufacturing compliance and device performance. The company is ceasing operations and cannot fulfill post-market safety responsibilities.
Universal Meditech Inc. is recalling PrestiBio Breast Milk Alcohol Test Strips because the company distributed them without FDA marketing authorization and cannot verify they were manufactured properly. The firm is ceasing operations and cannot fulfill post-market responsibilities.
Two medical device components in the Robotics Pack (I.V. Cath and Adhesive Dermabond) were improperly sterilized and may lose functionality or drug efficacy. Affected units distributed in Florida and Iowa.
Omega Medical Imaging is recalling 52 monitor suspension systems (Part Number 1000-0085) manufactured 2012–2019 in which the actuator may separate from the pivot mechanism. An installed safety cable contained one such failure, but the structural issue poses a falling hazard. No injuries reported.
American Contract Systems recalls Robotics Pack SAH components due to improper sterilization exposure. The IV catheter and adhesive components may lack functionality or contain excess sterilization residue.