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.
Maquet Cardiovascular is recalling Express chest drains pre-packaged with recalled sterile water syringes. If not kept upright, patients may be exposed to infectious material, risking infection, abscess, sepsis, and death.
Herold Salads, Inc. is recalling Greek Gemelli Pasta Salad due to potential Listeria monocytogenes contamination. The recall affects products distributed in Ohio, Pennsylvania, and Michigan.
Pfizer is recalling 34,000 cartons of 4.2% Sodium Bicarbonate Injection nationwide due to glass particles in the solution. Patients should immediately stop use and contact their supplier.
Par Sterile Products recalled Vasostrict (vasopressin) injection because stability testing showed the drug exceeded its upper potency specification limit. The recall involves 1,721 cartons distributed nationwide.
Olympus Corporation recalled 236 fiber cleaver units distributed non-sterile but labeled as reusable and autoclavable. Without validated sterilization instructions, use on sterile fiber poses contamination risk.
Getinge USA Sales Inc is recalling Maquet Equipment OR Light Systems due to a potential risk that the light systems could fall in the operating room. Approximately 236,793 units have been distributed.
Cook Medical is recalling MINC+ Benchtop Incubators that may lose temperature control when exposed to static electricity on the lid, potentially causing embryo damage that could require additional medical procedures.
Smiths Medical is recalling the Medex LOGICAL CATH LAB KIT due to a manufacturing defect where the O-ring inner diameter may be oversized, affecting seal integrity and potentially leading to medication under-infusion.
Smiths Medical is recalling approximately 31,685 units of a braided injection line due to manufacturing defects in the O-ring seal. The defect may cause medication leaks that reduce drug delivery.
TreeHouse Foods is recalling Organic Low/Reduced Sodium Chicken Broth sold under multiple brands due to potential microbial contamination. The recall affects 439,240 cases distributed across 37 states.
The FDA has recalled Old Spice SWEAT DEFENSE PURE SPORT PLUS anti-perspirant spray due to potential benzene contamination found at the manufacturing facility. All lots through September 2023 are affected.
A surgical guide used in knee replacement is recalled due to mislabeling showing incorrect dimensions. This could result in improper bone resection and implant fit, potentially extending surgery time.
Sarnova HC recalls 15 Curaplex Cricothyrotomy Field Kits nationwide due to an incompatible endotracheal tube holder that prevents proper tube securement during cricothyrotomy procedures.
The FDA has recalled Secret Dry Spray Antiperspirant in Waterlily scent due to potential benzene contamination at the manufacturing facility. All lots with expiration dates through September 2023 are affected.
TreeHouse Foods is recalling Full Circle 32oz Organic Chai Tea Latte (Lot 98E03223) due to potential microbial contamination. The product was distributed across the U.S., and consumers should not consume it.
The FDA is recalling multiple Maquet XTen OR Light System models because they may unexpectedly fall in the operating room. The recall affects 236,793 units distributed nationwide and globally.
The CareEvent patient monitoring device may fail to send push notifications, potentially delaying detection of patient condition changes.
Cardinal Health Suction Canister Liners may lose suction on low or intermittent settings due to liner misalignment. Approximately 3.5 million units are affected across the US, Canada, Australia, and New Zealand.
Getinge Usa Sales Inc is recalling Maquet Hanaulux HLX2000 OR Light Systems because the light fixture may fall from its mounting in the operating room. Nearly 237,000 units are affected.
Herold Salads, Inc. is recalling Cheddar Mac & Sour Cream salads due to potential Listeria monocytogenes contamination. Affected products were distributed in Ohio, Pennsylvania, and Michigan.
Getinge has recalled 236,793 Maquet Prismalix operating room light systems because the systems could potentially fall. The recall affects units distributed nationwide in the U.S. and globally.
Smiths Medical is recalling Medex injection line rotating adapters due to a manufacturing defect where the O-ring inner diameter may be oversized, potentially causing medication leaks during infusion.
Getinge USA is recalling 236,793 Maquet Rolite operating room light systems due to a potential for the light fixture to fall. No injuries have been reported.
Olympus recalls fiber stripper models sold before 2023 lacking validated sterilization instructions, creating a contamination risk when used on sterile medical fibers.
Olympus is recalling 82,200 units of SOLTIVE SuperPulsed Laser Fibers due to instruction inconsistencies that could cause fiber breakage during use, potentially resulting in burns or foreign material in the patient.