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.
Wishbone Design is recalling Recycled Edition Bikes because the handlebar can pinch fingers. The company reported four incidents, including two injuries requiring medical attention.
Pride Family Brands is recalling Bed Bath & Beyond Destination Summer Hammock Stands because the Z-shaped hooks can bend or break, causing consumers to fall.
Lippert is recalling Coachstep Double and Triple Electric Steps because a bolt may fracture, causing the steps to become unstable and increasing the risk of injury.
The Compounding Pharmacy of America is recalling HCG 1,000 IU/ml + MIC B-12 Injection due to FDA inspection findings of GMP violations that may impact sterility.
Applied Medical Resources Corp is recalling Voyant Open Fusion Devices due to a potential risk of improper tissue characterization, which may result in nonoptimal power delivery.
The Compounding Pharmacy of America is recalling Testosterone Enanthate 200 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
Fiat is recalling 2015 500L vehicles because the passenger air bag may not deploy correctly, increasing injury risk in a crash.
Revmedx Inc is recalling XGAUZE Trauma Dressings because shipping containers may have caused small tears or pinholes in the packaging, potentially rendering the sterile devices unsterile.
Medtronic is recalling 103 CryoConsole units because a USB memory component issue can result in extended procedure time during cardiac ablation.
Valley View Orchard Pies Inc. is recalling Blueberry Crisp products due to undeclared soy lecithin. The products were distributed in Maine, New Hampshire, and Massachusetts.
Nico Corp. is recalling six Myriad Console units because twisted cables may cause wire breaks or shorts, leading to unexpected aspiration increases during surgery.
Medivators, Inc. is recalling 840 Hemocor HPH700 Hemoconcentrators because they may exhibit low ultrafiltration performance below product specifications.
The Compounding Pharmacy of America is recalling LIPO-VITE Injection vials because an FDA inspection found GMP violations that may affect sterility.
Valley View Orchard Pies Inc. is recalling Bumbleberry Pies due to undeclared soy lecithin. The product was distributed in Maine, New Hampshire, and Massachusetts.
Sony Medical Systems is recalling 4,952 medical monitors that may fail to turn on or lose image during clinical use.
Valley View Orchard Pies Inc. is recalling Apple Crisp Tray products due to undeclared soy lecithin. The products were distributed in Maine, New Hampshire, and Massachusetts.
The Compounding Pharmacy of America is recalling Clotrimazole 2% Otic Suspension due to FDA inspection findings of GMP violations that may impact sterility.
KellBran Candies is recalling 8 oz. bags of creamy rich caramel popcorn because the product may contain undeclared milk, a major food allergen.
Valley View Orchard Pies Inc. is recalling Apple Crisp Pies due to undeclared soy lecithin. The product was distributed in Maine, New Hampshire, and Massachusetts.
Valley View Orchard Pies Inc. is recalling Pecan Pies due to undeclared soy lecithin. The product was distributed in Maine, New Hampshire, and Massachusetts.
The Compounding Pharmacy of America is recalling Nandrolone Decanoate 200 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
Bayer Healthcare is recalling 71 Medrad Mark 7 Arterion Injection Systems due to a software defect that removes purge enforcement, potentially affecting angiographic studies.
Stryker Orthobiologics is recalling 9,805 Aliquot Delivery Kits because two instances of holes were found in the sterile packaging, which could compromise sterility.
The Compounding Pharmacy of America is recalling Testosterone 100 mg sterile pellets nationwide because FDA inspections found GMP violations affecting sterility.
The Compounding Pharmacy of America is recalling MEGA-BURN Injection due to FDA inspection findings of GMP violations that may impact sterility.