The Recall Desk

Severity 5 of 5

Critical recalls

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.

What “critical” means here

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.

451–475 of 7436

  • CriticalFDA (Devices)·Z-0069-2026·2025-10-15

    Heart pump controllers recalled over potential operating system cybersecurity vulnerabilities

    Abiomed is recalling 10,153 Automated Impella Controllers over potential cybersecurity vulnerabilities related to the controller's operating system.

    Product
    Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0028-2026·2025-10-15

    Nitric oxide delivery systems recalled over dose fluctuations at low flow

    NOxBOX is recalling 1,667 NOxBOXi Nitric Oxide Delivery Systems because delivered dose may fluctuate when total flow through the device sensor falls below its 0.5 LPM minimum.

    Product
    NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Food)·H-0023-2026·2025-10-15

    Ahi tuna poke recalled after green onion supplier reported Listeria

    Western United Fish Company is recalling 3,314.7 lbs of Kirkland Signature Ahi Tuna Wasabi Poke after its green onion supplier reported a Listeria monocytogenes positive test result.

    Product
    Kirkland Signature brand Ahi Tuna Wasabi Poke, Costco #17193, net wt. 1lb. Product is packaged in clear plastic clamshell container and sold to consumers.
    Category
    Food
    Distribution
    37 states
  • CriticalFDA (Food)·H-0029-2026·2025-10-15

    Asiago Texas toast recalled for undeclared milk from cheese and butter

    Harris Teeter is recalling 295 units of its Asiago Texas Toast after finding that cheese and butter were left off the ingredient statement, so milk was not declared.

    Product
    Harris Teeter ASIAGO TEXAS TOAST, NET WT 5.0OZ (0.3lb), INGREDIENTS BREAD***CONTAINS WHEAT, UPC 0 72036 95364 3, Harris Teeter Raleigh, NC
    Category
    Food
    Distribution
    8 states
  • CriticalFDA (Food)·H-0077-2026·2025-10-15

    Cooked penne pasta recalled over potential Listeria monocytogenes contamination

    Nate's Fine Foods is recalling 1,337 cases of Fresh Creative Foods cooked penne, totaling 32,088 lbs, for potential contamination with Listeria monocytogenes.

    Product
    FRESH CREATIVE FOODS COOKED PENNE PASTA 8 x 3 lb pouches Net Weight: 24 lbs (10.88 kg) PERISHABLE KEEP REFRIGERATED
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·H-0076-2026·2025-10-15

    Cooked farfalle pasta recalled again over potential Listeria monocytogenes contamination

    Nate's Fine Foods is recalling 1,442 cases of Fresh Creative Foods cooked farfalle, totaling 34,068 lbs, for potential contamination with Listeria monocytogenes.

    Product
    FRESH CREATIVE FOODS COOKED FARFALLE PASTA 8 x 3 lb pouches Net Weight: 24 lbs (10.88 kg) PERISHABLE KEEP REFRIGERATED
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·H-0079-2026·2025-10-15

    Cooked rotini pasta recalled over potential Listeria monocytogenes contamination

    Nate's Fine Foods is recalling 383 cases of Taylor Farms cooked rotini, totaling 9,192 lbs, for potential contamination with Listeria monocytogenes.

    Product
    TAYLOR FARMS COOKED ROTINI MAP 8 X 3 lb pouches Net Weight: 24 lbs (10.88 kg) PERISHABLE KEEP REFRIGERATED
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Devices)·Z-0029-2026·2025-10-15

    Nitric oxide systems recalled over fault from rapid button presses

    NOxBOX is recalling 1,667 NOxBOXi Nitric Oxide Delivery Systems because a rapid succession of button selections can trigger an unexpected internal fault or system diagnostic error.

    Product
    NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Food)·H-0024-2026·2025-10-15

    Kimchi mackerel containers recalled for undeclared milk and shrimp allergens

    Lee K of NY is recalling 43 containers of Pinocchio Catering Aged Kimchi Mackerel because the product contains undeclared milk and shrimp.

    Product
    PINOCCHIO CATERING Aged Kimchi Mackerel; 57oz; 27330700000 in black bottomed plastic container
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-0094-2026·2025-10-15

    NAD+ injection recalled after elevated endotoxin levels found in one lot

    GenoGenix is recalling NAD+ for Injection at 100 mg/mL and 200 mg/mL from one lot for microbial contamination of sterile products, with elevated endotoxin levels.

    Product
    NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 mg/mL, 10 mL multi-dose amber vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0011-2026·2025-10-15

    Shell eggs recalled over potential Salmonella contamination across four brands

    Country Eggs is recalling 81,542 dozen shell eggs sold under four brand names in California and Nevada because the product is potentially contaminated with Salmonella.

    Product
    o Nagatoshi Large AA Brown Omega-3 1 dozen cartons o Nijiya Large AA Brown Golden Yolk 1 dozen cartons o Mizuho Large AA Brown Omega-3 Cage 1 dozen cartons o Country Eggs Large AA Brown Sunshine Yolk 15 dozen bulk loose
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·H-0080-2026·2025-10-15

    Cooked farfalle pasta recalled over potential Listeria monocytogenes contamination

    Nate's Fine Foods is recalling 261 cases of Taylor Farms cooked farfalle, totaling 6,264 lbs, for potential contamination with Listeria monocytogenes.

    Product
    TAYLOR FARMS COOKED FARFALLE MAP 8 X 3 lb pouches Net Weight: 24 lbs (10.88 kg) PERISHABLE KEEP REFRIGERATED
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Devices)·Z-0035-2026·2025-10-15

    Infusion pump sets recalled over flow rate and occlusion alarm accuracy

    CareFusion is recalling BD Alaris Pump Infusion Sets because the pump module used with them may perform outside established ranges for flow rate, bolus accuracy and occlusion alarm timing.

    Product
    BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site 10015414, 180 Micron Filter 2447-0007, Ball Valve SmartSite Port (Burette) 2 SmartSites Y-Sites 24201-0007, 2 SmartSite Y-sites
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2670-2025·2025-10-08

    Surgical valve pack kits recalled after cannulas may not retain shape

    Medline is recalling 828 VALVE PACK-LF kits because they contain lots of cannula products where the catheter may not retain its shape.

    Product
    Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2665-2025·2025-10-08

    MAGNETOM Verio Dot systems recalled over magnet venting ice blockage risk

    Siemens is recalling 59 MAGNETOM Verio Dot systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.

    Product
    MAGNETOM Verio Dot. Model Number: 10684333.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2617-2025·2025-10-08

    Atlan A350XL anesthesia workstations recalled after piston ventilator failures during use

    Draeger is recalling 223 Atlan A350XL anesthesia workstations that either indicated a piston ventilator failure before use or suffered a mechanical ventilation failure during use.

    Product
    Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ve
    Category
    Medical Device
    Distribution
    25 states
  • CriticalFDA (Devices)·Z-2614-2025·2025-10-08

    Reprocessed ultrasound catheters recalled over residual particulates on patient contacting surfaces

    Medline is recalling 7,913 reprocessed ACUSON AcuNav ultrasound catheters because specific lots may carry small residual particulates on patient-contacting surfaces.

    Product
    Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. For imaging guidance only, not treatment delivery, during cardiac interventio
    Category
    Medical Device
    Distribution
    Distributed nationwide