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.
Philips Medical Systems Nederland is recalling 14 units of the Allura Xper FD10/10, model 722005, because the drip tray beneath the cooling unit may not have been installed.
Philips Medical Systems Nederland is recalling 79 units of the Allura Xper FD20, model 722012, because the drip tray beneath the cooling unit may not have been installed.
Medline is recalling 633 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.
Medline is recalling 96 units of procedure convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.
Medtronic is recalling 7,123 units of the Vanta Clinician Programmer Application after complaints that it does not function as intended during use.
Medicrea International is recalling 44 IB3D Universal Implant Inserters because, following complaints, the orthopedic rotation tool handle may untread from the shaft.
Philips Medical Systems Nederland is recalling 143 units of the Allura Xper FD20, model 722006, because the drip tray beneath the cooling unit may not have been installed.
Medline is recalling 12 units of procedure convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.
Heraeus Medical is recalling PALACOS R+G pro 40 and PALACOS R+G pro 80 bone cement because an unfortunate combination of factors can leave ampoules unbroken, so no appropriate cement dough is formed.
Philips Medical Systems Nederland is recalling 93 units of the Allura Xper FD10, model 722003, because the drip tray beneath the cooling unit may not have been installed.
Fresenius Kabi is recalling 30 units of Ivenix Infusion System LVP software to emphasize the instructions for LVP duration programming set out in the IFU.
Mobius Imaging is recalling 26 detachable 10in pendant upgrade components for the AIRO CT X-ray System because they do not carry the Safe Hand Position Warning label.
Mobius Imaging is recalling 101 detachable 10in pendant replacement components for the AIRO CT X-ray System because they do not carry the Safe Hand Position Warning label.
Ambriola is recalling 179 bags of Ambriola Piccante grated Pecorino Romano in 5 and 10-pound sizes after the product tested positive for Listeria monocytogenes.
MediNatura is recalling all lots within expiry of ReBoost Nasal Spray after the products were found to contain yeast, mold and microbial contamination identified as Achromobacter.
AVID Medical is recalling 132 Halyard Organ Recovery OR Packs, kit code LLOG1000-15, because the devices are not suitable for organ transplant.
GBC Food Services is recalling 2 units of EverRoast Chicken Caesar Salad over the potential presence of Listeria monocytogenes. The FDA has classified the action as Class I.
AVID Medical is recalling 52 Halyard Organ Recovery OR Packs because the devices are not suitable for organ transplant. The FDA has classified the action as Class I.
Lund Food Holdings is recalling 108 cases of Lunds & Byerlys Monster Cookies over undeclared peanut, egg and soy. The FDA has classified the action as Class I.
Ambriola is recalling 1,015 bags of Sam's Pecorino Romano grated, 1.5 lb, after the product tested positive for Listeria monocytogenes.
South Asian Food is recalling 95 boxes of Bengal King Jhal Chanachur food treats because the product contains undeclared peanuts. The FDA has classified the action as Class I.
Ambriola is recalling 184 units of Locatelli Grated Pecorino Romano 48/8oz shippers after the product tested positive for Listeria monocytogenes.
GBC Food Services is recalling 11 units of EverRoast Chicken Caesar Wrap over the potential presence of Listeria monocytogenes. The FDA has classified the action as Class I.
Ambriola is recalling 2,106 units of Boar's Head Grated Pecorino Romano in 6 oz cups after the product tested positive for Listeria monocytogenes.
Ambriola is recalling 6,632 units of Locatelli Grated Pecorino Romano in 4 oz and 8 oz cups after the product tested positive for Listeria monocytogenes.