Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Tidal Seafood is recalling Yellowfin Tuna Saku Block products due to possible elevated histamine levels. The product was distributed to California, Texas, and New Mexico.
Hobbs Medical, Inc. is recalling Grasping Forceps due to incorrect expiration dates on device labels. Affected devices may be used beyond their safe shelf life if the mislabeled expiration dates are not corrected.
Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent Kits with incorrect expiration dates on labels, potentially allowing devices to be used beyond their actual safe shelf life. Affected units were distributed from March 2018 to September 2020.
Hobbs Medical recalls Freeman Pancreatic Flexi-Stent Kits due to labeling errors showing incorrect expiration dates that extend the shelf life of affected devices.
Certain PET/CT imaging systems may lose vital sign monitoring due to Wi-Fi interference, potentially requiring patient rescans.
Baxter Healthcare is recalling Prismaflex M Sets (524,376 devices nationwide) due to a mistranslation in instructions for use that provides contradictory patient body weight restrictions for renal replacement therapy.
Hobbs Medical is recalling its Cytology Brush (catalog 4204) because device labels show incorrect expiration dates that extend the claimed shelf life. Affected devices were distributed in the US and several other countries from March 2018 to September 2020.
Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices due to incorrect expiration dates on the device labels. Affected units distributed in the US and internationally from March 2018 to September 2020 may have been used beyond their actual safe shelf life.
Hobbs Medical is recalling Biliary Pigtail Stent Kits due to incorrect expiration dates on device labels that extend shelf life, affecting 15 units distributed from March 2018 to September 2020.
Hobbs Medical is recalling Freeman Pancreatic Flexi-Stents with incorrect expiration dates on device labels that extend shelf life. Devices were distributed in the US and internationally from March 2018 to September 2020.
Hobbs Medical is recalling Posi-Stop Injection Needles due to incorrect expiration dates on device labels that extend shelf life. Devices distributed between March 2018 and September 2020 could be used beyond their actual expiration.
Hobbs Medical is recalling Biliary Pigtail Stent Kits for incorrect expiration dates on product labels that may extend shelf life. Affected kits were distributed nationwide and internationally between March 2018 and September 2020.
Hobbs Medical is recalling transbronchial aspiration needles with incorrect expiration dates on labels. The 18 affected units were distributed in the US, Canada, Austria, Belgium, Finland, and Norway from March 2018 to September 2020.
Hobbs Medical is recalling Polypectomy Snare devices (Catalog Number 4564) due to incorrect expiration dates on labels that extend the stated shelf life. The 35 affected units, distributed in the US and select countries, may be used beyond their actual safe shelf life.
Hobbs Medical, Inc. is recalling Posi-Stop Injection Needles with lot numbers ending in 'R' due to incorrect expiration dates on device labels. The mislabeling extends the apparent shelf life, potentially allowing use of expired sterile devices.
Hobbs Medical recalled Freeman Pancreatic Flexi-Stents due to incorrect expiration dates on device labels. The mislabeled dates extend shelf life, potentially allowing use of expired devices.
Worldwide Seafood Products LLC is recalling 40 cases of Tidal Seafood Yellowfin Tuna Poke (Best Buy 6/18/2024) distributed to California, Texas, and New Mexico due to potential elevated histamine levels in the frozen tuna.
Hobbs Medical is recalling Retrieval Forceps with incorrect expiration dates on device labels. Affected devices distributed between March 2018 and September 2020 may be used past their actual expiration.
Hobbs Medical recalled Freeman Pancreatic Flexi-Stent devices due to incorrect expiration dates on labels that extend the shelf life, potentially allowing use beyond intended timeframe.
Hobbs Medical is recalling certain Biliary Pigtail Stent Kits due to incorrect expiration dates on device labels that extend shelf life beyond actual validity. Affected devices distributed between March 2018 and September 2020 may be used beyond their true expiration date.
Hobbs Medical is recalling Biliary Pigtail Stent Kits due to incorrect expiration dates on device labels that extend shelf life beyond actual product expiration, potentially resulting in use of expired devices.
Baxter Healthcare is recalling 334,932 Prismaflex M Set M150 devices due to a mistranslation in instructions that creates contradictory information about patient body weight restrictions.
Hobbs Medical is recalling Polypectomy Snare model 4565-OLY due to incorrect expiration dates on device labels that extend the product's shelf life. Affected devices were distributed between March 2018 and September 2020.
Hobbs Medical recalls Freeman Pancreatic Flexi-Stent Kits with incorrect expiration dates on labels that may extend shelf life beyond the actual expiration date.
Justified Laboratories is recalling Skincell Mole & Skin Corrector Serum. The product was marketed as a drug without FDA approval (NDA/ANDA).