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.
Stryker is recalling 1,542 Advanced Cement Mixing Kits because bioburden levels exceeded acceptable rates, posing a sterility risk.
Zimmer Biomet is recalling the ACE Trochanteric Nail System after a device performance review failed clinical analysis for survivorship.
Zimmer Biomet is recalling the ACE Trochanteric Nail System after a device performance review failed to meet clinical survivorship criteria.
Stryker is recalling 30 units of the Revolution 90 Degree Tibial Nozzle because bioburden levels exceeded acceptable rates, posing a sterility risk.
Zimmer Biomet is recalling 24 hip implant packages labeled as size 7.5 Extended Offset Reduced Neck length that actually contained Size 4 Standard Reduced Neck length implants.
Griffith Foods is voluntarily recalling Whiskey & Cola Type Flavored Seasoning because a supplier recalled Autolyzed Yeast Powder for Salmonella.
Cook Vascular Inc. is recalling Vital-Port Vascular Access Systems because the included non-coring needle may cut or dislodge material from the device septum during initial implant.
FDA is recalling 15,885 rechargeable lithium-ion batteries for Puritan Bennett 980 ventilators due to incorrect firmware that may prevent full charging.
ConMed is recalling 18,720 Mini Infant Radiotranslucent Electrodes because adhesive on the contact wires may impede conductivity and cause failure.
Badass Helmet Company is recalling Metalhead 2.5 helmets because they may not adequately protect wearers in a crash, failing federal safety standards.
Zimmer Biomet is recalling the ACE Trochanteric Nail System after a Device Performance Review failed clinical analysis for survivorship.
Newly Weds Foods is recalling Roast Chicken Marinade because a supplier recalled yeast containing salmonella. The product was distributed in Pennsylvania, Illinois, Arkansas, and Kansas.
Covidien LLC is recalling 2,121 Signia Power Handles because they reportedly shut down during use. The devices are used in various surgical procedures.
Schwartz Brothers Bakery is recalling 106 units of Gourmet Cream Cheese Cinnamon Rolls due to undeclared egg. The product was distributed in Washington.
Stryker is recalling AutoPlex bone cement systems because bioburden levels were found to be higher than acceptable rates, potentially compromising sterility.
Newly Weds Foods is voluntarily recalling dry blended seasonings for industrial use because a supplier recalled yeast containing salmonella.
Roche Molecular Systems is recalling cobas MRSA/SA tests worldwide due to decreased performance that may lead to screening failures and potential infection spread.
Stryker is recalling specific lots of Femoral Canal Pressurizers because bioburden levels were found to be higher than acceptable rates, potentially compromising sterility.
DePuy Orthopaedics is recalling specific Sigma HP Cemented Trochlear Implants due to elevated revision rates identified during post-market surveillance.
Konica Minolta is recalling 17 Sonimage HS1 Ultrasound Kit AC adapters due to a risk of circuit board breakage and smoke emission.
Stryker is recalling 320 Intramedullary Brushes because bioburden levels exceeded acceptable rates, compromising sterility assurance.
Cook Inc. is recalling specific lots of Echosight Jansen-Anderson Intratubal Transfer Sets because they were distributed without completed quality testing, posing a risk of nonviable embryos.
Arrow International is recalling specific lots of Endurance Extended Dwell Peripheral Catheter Systems because they may be missing a safety latch designed to prevent sharps injuries.
Zimmer Biomet is recalling the ACE Trochanteric Nail System because a Device Performance Review failed clinical analysis for survivorship.
Deerfield Imaging is recalling 17 IMRIS ORT200 operating room tables because their rotational locking mechanisms fail to operate, preventing the table from changing between locked and unlocked states.