Severity 5 of 5
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Severity 5 (Critical) covers recalls where deaths or serious injuries have been reported, or where the agency itself classified the action as the highest severity (FDA Class I, NHTSA 'death/serious injury reported'). These are the recalls you should treat as urgent — stop using the product immediately and follow the agency's guidance. Common Severity-5 categories are pathogen-contaminated ready-to-eat foods (Listeria, E. coli O157, Salmonella), drug products with confirmed adverse-event reports, and vehicle defects with documented fatal crashes.
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.
Boston Scientific is issuing a software update for ACCOLADE family pacemakers to prevent improper Safety Mode activation related to high battery impedance in ambulatory settings. The update affects approximately 61,700 units of multiple pacemaker models distributed worldwide.
Abbott is recalling its TactiFlex cardiac catheters for tip detachment events occurring during removal from packaging. The recall affects 11,810 units worldwide.
Boston Scientific is recalling certain pacemaker models due to potential inappropriate Safety Mode initiation in ambulatory settings. A software update is available to address a high battery impedance issue.
Boston Scientific is recalling 1,050 pacemaker and cardiac resynchronization therapy devices worldwide due to potential high battery impedance causing unwanted Safety Mode activation. Software to prevent this issue is available.
Olympus is updating instructions for its EVIS EXERA bronchoscope to clarify safe use when combined with laser, argon plasma coagulation, and high-frequency therapy equipment.
Country Eggs, LLC is recalling shell egg products due to potential Salmonella contamination. The eggs were distributed in California and Nevada with sell-by dates between July 1, 2025 and September 18, 2025.
Chefs Warehouse is recalling Cucumber Select 15ct due to potential Salmonella contamination. The product was distributed to Maryland, Delaware, and Virginia.
Chefs Warehouse is recalling 15-pound units of diced cucumbers contaminated with Salmonella. The product was distributed to Maryland, Delaware, and Virginia.
Medline is recalling reprocessed ACUSON AcuNav ultrasound catheters that may have residual particulates, creating risk of infection, blood clots, or embolism.
Middlefield Original Cheese Cooperative recalls Sunrise Creamery Dilly Pickle Monterey Jack Cheese due to potential contamination with Listeria monocytogenes. Affected products were distributed in Ohio, Pennsylvania, Wisconsin, and Texas.
Latitude 36 Foods is recalling Honey Balsamic dressing in 3.4 ounce pouches due to undeclared soy and sesame. Consumers with soy or sesame allergies should not consume this product.
Peeled and diced cucumbers sold by PRIMO NO. 1 IN PRODUCE, INC have been recalled due to Salmonella contamination. The product was distributed in Virginia, New York, Pennsylvania, and New Jersey.
Baxter Healthcare recalls Novum IQ infusion pumps due to software anomalies that may cause blank display screens or false motor movement alerts. 43,922 units affected.
Baxter Healthcare is recalling Novum IQ Syringe Pumps due to software defects that may cause blank Run screens or false motor movement errors. Approximately 22,703 units distributed in the US, Puerto Rico, and Canada are affected.
Sprouted moong products manufactured by Chetak New York LLC are being recalled due to Salmonella contamination. The affected product was distributed in California, New Jersey, Illinois, Florida, and Texas.
Hillside Orchard Farms is recalling Strawberry Bread (23 oz packages) due to undeclared egg, a common food allergen. The product was distributed in Alabama, Georgia, North Carolina, Pennsylvania, and South Carolina.
Hillside Orchard Farms is recalling Jalapeno Cheese Bread (23 oz packages) due to undeclared egg. The product was labeled only for milk, soy, and wheat but contains egg, posing a serious risk to consumers with egg allergies.
Fresh Blackberry Bread from Hillside Orchard Farms is being recalled for undeclared egg. The product was distributed in Alabama, Georgia, North Carolina, Pennsylvania, and South Carolina.
Hillside Orchard Farms is recalling Fresh Apple Bread due to undeclared egg, a common allergen not listed on the label. The product was distributed to Alabama, Georgia, North Carolina, Pennsylvania, and South Carolina.
Boston Scientific recalls ENDOTAK RELIANCE defibrillation leads that may calcify over time, potentially requiring early replacement and posing cardiac risk.
Multiple models of RELIANCE 4-FRONT defibrillator leads may develop calcification, leading to device failure and potential cardiac emergencies.
Albertsons Companies is recalling Randalls 12-inch salad sandwich trays sold across multiple states due to potential Listeria monocytogenes contamination. Consumers should discard affected products or return them to the point of sale.
Signature Cafe Premium Tuna Salad (3-pound foodservice size) is recalled due to potential Listeria monocytogenes contamination from recalled Japanese Style Breadcrumbs. The recall affects 165 cases distributed across 29 U.S. states.
Albertsons Companies is recalling Randalls PREMIUM TUNA SALAD due to potential Listeria monocytogenes contamination. The product was distributed in Iowa, Illinois, Indiana, Arkansas, Louisiana, Oklahoma, and Texas.
King Cheesecake Company is recalling Item #2485 Assorted layer cake due to potential Salmonella contamination in pecans. Products manufactured June 20 to July 14, 2025, were distributed in AL, TX, FL, LA, OK, and IL.