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.
HealthWise Menstrual Pain Relief Patch (Menthol 10%) is recalled due to manufacturing quality deviations. The firm-initiated recall affects 10,368 patches distributed nationwide in the US.
GE Healthcare is recalling certain Proteus XR/A radiographic systems because steel cables in the Wall Stand component have not been replaced at manufacturer-specified maintenance intervals.
Neogen Corporation voluntarily recalled 5,328 sachets of LICEOUT lice treatment due to manufacturing practice violations. The product was distributed to Bob Barker Company for institutional facilities.
Abbott is recalling 130 Merlin@home cardiac transmitters that cannot update software after power interruption during firmware download. Affected devices remain on outdated firmware with no ability to receive future updates.
Neogen Corporation has voluntarily recalled LICEOUT liquid lice treatment due to manufacturing practice violations. The recall affects 8,328 jugs distributed to institutions.
Water condensation may accumulate under the autosampler's thermal insulation and damage the main board, causing communication errors and delays in laboratory testing. Two Shimadzu models are affected: SIL-40C XR CL and SIL-40C X3 CL.
J.R. Watkins is recalling Cooling Menthol Extra Strength Pain Relief Patches nationwide due to manufacturing practice deviations. The recall affects approximately 7,138 patches from lots JC101, JC102, and JC103.
Unexo Life Sciences Private Limited is voluntarily recalling Parche Leon pain relief patches due to manufacturing practice deviations. No illnesses or injuries have been reported.
ABSORBINE jr. Extra Large Back Patch containing 5% menthol is being recalled nationwide due to manufacturing compliance deviations. The Class II recall affects 6,848,820 patches distributed by Absorbine Jr., LLC.
Equate Maximum Strength Lidocaine Pain Relieving Patches (4%) are being recalled due to current Good Manufacturing Practice deviations. Approximately 1.1 million patches were distributed nationwide in the US.
Zyno Medical LLC is recalling Z-800WF infusion pumps due to incompatibility between WiFi software and the pump's operating software. The affected units were distributed in eight U.S. states.
FDA recalls THERA CARE COLD HOT MEDICATED PATCH (menthol 5%) due to manufacturing practice deviations. The voluntary recall affects 279,936 patches distributed nationwide.
JR Watkins Cooling Pain Relief Patches are being recalled due to manufacturing process deviations identified during production.
THERACARE MAXIMUM STRENGTH PAIN RELIEF PATCH (4% lidocaine) is being recalled nationwide due to manufacturing practice deviations. Unexo Life Sciences, the manufacturer, voluntarily initiated the recall after identifying quality control issues.
Cheeky Bonsai Pain Relief Patches (Menthol 10%) are being recalled nationwide due to manufacturing facility compliance deviations. The voluntary recall affects 17,928 patches distributed across the US.
Medline is recalling Endo Kit models containing Olympus components with missing sterile and manufacturing lot numbers and expiration dates on packaging. Without this labeling, medical facilities cannot verify product expiration or track inventory.
GE Medical Systems is recalling SIGNA PET/MR and DISCOVERY PET/MR imaging systems because gradient coils can produce elevated acoustic noise during scanning under specific conditions.
Abbott Medical's Merlin@home transmitter cannot upgrade to current software after power interruptions during prior downloads. This affects remote heart device monitoring systems.
Unexo Life Sciences is voluntarily recalling LILAS Feminine Pain Relief Patch nationwide due to manufacturing practice deviations affecting 363,300 patches.
Unexo Life Sciences is recalling Absorbine Jr Pain Relieving Knee Patch nationwide due to manufacturing process deviations that do not meet FDA standards. No illnesses or injuries have been reported.
Remote Diagnostic Technologies Ltd. is recalling Tempus LS-Manual Defibrillator Model 00-3020 units distributed in eight U.S. states. The devices were labeled incorrectly during servicing with wrong product name and CAT number.
Joseph Seviroli, LLC is recalling Chicken Alfredo Kit due to potential Listeria monocytogenes contamination in the chicken. The product was distributed across multiple states.
Baxter Healthcare Corporation is recalling 1,240 units of MiniCap Extended Life PD Transfer Sets (Part Number T5C4484) due to potential exposure to polychlorinated biphenyls and related compounds when used in peritoneal dialysis treatments.
Grand Central Bakery FRE Co Inc is recalling 150 packages of U-BAKE Apple Pie due to undeclared egg. The product label declares wheat and milk but not egg, posing a serious risk to consumers with egg allergies.
Baxter Healthcare is recalling the MiniCap Extended Life PD Transfer Set due to potential exposure to polychlorinated biphenyls (PCBs). Approximately 410,862 units are affected.