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.
CareFusion 213, LLC is recalling ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol applicators distributed nationwide because unsterilized units intended for further processing were distributed through the wrong channels.
Windstone Medical Packaging is recalling AMS Dr. Lewin Pack surgical convenience kits (45 units) distributed nationwide because they contain Webcol alcohol prep pads contaminated with Paenibacillus phoenicis bacteria.
W. L. Gore & Associates is recalling 467 GORE TAG Thoracic Branch Endoprosthesis Side Branch Components worldwide due to risk of catheter separation during deployment.
Accuray Incorporated is recalling Cyberknife Treatment Delivery Systems equipped with the Xchange Robotic Collimator Changer due to a risk that the collimator may not fully dock and could fall from the housing if the in-room control pendant is used.
A M S Preop Kit-NS surgical convenience kits are being recalled due to contamination with Paenibacillus phoenicis bacteria discovered during sterilization testing. The kits were distributed nationwide in PA, GA, CA, and WA.
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, creating a lack of sterility assurance.
Accuray Incorporated is recalling Cyberknife Treatment Delivery Systems with the Xchange Robotic Collimator Changer because a collimator may fail to fully dock and fall from the housing if room-control pendant motion is initiated while the system interlock is bypassed.
Baxter Healthcare is recalling Hillrom VOLARA System patient circuits due to reports of air and medication leakage from the nebulizer cup, which can reduce oxygen levels and prevent proper medication delivery.
Shaman Botanicals, LLC is recalling White Vein Advanced Alkaloids Chewable Tablets because testing found the active ingredient 7-hydroxymitragynine is present in a quantity greater than the labeled specification.
Accord BioPharma is recalling IMULDOSA (ustekinumab-srlf) Injection due to lack of assurance of sterility. The affected lot was distributed nationwide.
NARA ORGANICS Whole Milk Organic Infant Formula in 24.7 oz and 14.1 oz sizes is being recalled nationwide because the product may be contaminated with Clostridium botulinum.
Medline Industries is recalling reprocessed electrophysiology and ultrasound catheters with residual particles that may cause inflammation, infection, or blood clots if contacted with blood or the heart.
Hamilton Medical AG is recalling coaxial breathing circuit sets used with three ventilator models because membranes may stick to the expiratory valve body, preventing proper gas exhalation and potentially causing inadequate ventilation.
Boston Scientific is recalling CRE Wireguided 10-12mm 240cm medical devices due to a potential sterile breach in the product packaging. The breach could compromise device sterility and affect patient safety.
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, creating a lack of assurance of sterility.
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators nationwide because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, lacking sterility assurance.
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators that were intended for sterilization but were instead distributed unsterilized to customers outside the intended distribution channel.
Cipla USA, Inc. is recalling Cinacalcet Hydrochloride Tablets, 60 mg due to cGMP deviations involving the presence of N-nitroso-cinacalcet above acceptable daily intake levels.
Boston Scientific Corporation is recalling the CRE Wireguided 6-8mm 240cm device worldwide due to a potential sterile breach of the packaging pouches.
Cipla USA, Inc. is recalling Cinacalcet Hydrochloride 90 mg tablets (Lot #5PB0563, expiring 4/30/2027) distributed nationwide due to the presence of N-nitroso-cinacalcet above acceptable daily intake levels, a manufacturing deviation.
Windstone Medical Packaging is recalling 1,080 DSAEK Pack-RX surgical convenience kits containing Webcol Large Alcohol Prep Pads contaminated with Paenibacillus phoenicis bacteria discovered during a sterilization audit.
Baxter Healthcare Corporation is recalling the Hillrom VOLARA P.CIRCUIT 5KIT medical device due to reports of air and medication leakage from the nebulizer cup, which can reduce oxygen levels and compromise medication delivery.
CareFusion 213, LLC is recalling 7,650 units of ChloraPrep One-Step antiseptic applicators distributed nationwide because unsterilized product intended for further processing was distributed through incorrect channels.
Medtronic is recalling certain lots of the Harmony Delivery Catheter System due to a manufacturing issue that may cause the distal tip to detach from the delivery system during procedures.
Asclemed USA Inc. is recalling Lidocaine Hydrochloride Injection USP, 1% (10 mg/mL) in 5 mL single dose ampules nationwide due to lack of assurance of sterility. The affected lots have expiration dates of 11/30/2026 and 04/30/2028.