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.

176–200 of 758

  • CriticalFDA (Devices)·Z-1289-2025·2025-03-19

    Portex Endotracheal Tubes may deliver inadequate ventilation due to smaller diameter

    Portex Endotracheal Tubes from Smiths Medical ASD, Inc. may have a smaller diameter than expected, potentially causing inadequate ventilation and patient hypoxia.

    Product
    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0588-2025·2025-03-12

    Watermelon and Cucumber Products Recalled for Potential Salmonella Contamination

    JFE Franchising is recalling watermelon and cucumber products with Tajin seasoning due to potential Salmonella contamination. Affected packages were distributed in TX, LA, WY, and AZ with sell-by dates from October 12 through December 5, 2024.

    Product
    Mixed Melon, Cucumber & Tajin 18 oz Watermelon & Cucumber w/ Tajin 18 oz packed in clamshells
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Devices)·Z-1244-2025·2025-03-12

    Rotarex Atherectomy Catheter Recalled for Helix Fracture Risk

    Bard is recalling Rotarex Atherectomy System catheters due to potential helix fracture or breakage that could cause vessel injury and severe bleeding. Updated instructions are being distributed to clarify procedural steps to reduce this risk.

    Product
    Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1257-2025·2025-03-12

    Insulin pump recall: Medtronic Paradigm models malfunction during airplane flight

    Medtronic MiniMed's Paradigm insulin pumps can malfunction during airplane flight due to air pressure changes, potentially causing dangerously high or low blood sugar levels that could be fatal.

    Product
    Paradigm insulin pump, REF: MMT-754
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0578-2025·2025-03-05

    Gerber Baby Teething Sticks Recalled Due to Choking Risk

    Nestlé-USA is recalling all lots of Gerber Snacks for Baby Soothe 'n' Chew Teething Sticks in Strawberry Apple flavor following complaints of infant choking. The product was distributed across 42 states and Puerto Rico.

    Product
    Gerber Snacks for Baby Soothe 'n' Chew TEETHING STICKS Strawberry Apple NET WT 3.2 OZ (90g) UPC 0 15000 04518 7 GERBER PRODUCTS CO., FREMONT, MI 49413
    Category
    Food
    Distribution
    45 states
  • CriticalCPSC·25157·2025-02-27

    Gas boilers recalled for carbon monoxide poisoning risk; two deaths reported

    Triangle Tube is recalling approximately 60,000 Prestige and Aerco Esteem gas boilers due to carbon monoxide release hazard. Two deaths and 25 CO leak incidents have been reported.

    Product
    Prestige Solo, Prestige Excellence, and Aerco Esteem condensing gas boilers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1070-2025·2025-02-26

    Vascular Tack Endovascular System recalled for deployment and migration risks

    Spectranetics' Intact Vascular Tack Endovascular System may fail to deploy properly or migrate in blood vessels, potentially causing ischemia and requiring additional intervention.

    Product
    Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041; Tack, 4F Gen 1.5, 150cm CE, REF: 154150042; Tack, 4F Gen 1.5, 90cm CE, REF: 154090042 (6F, 3.5 - 6.0mm), 135cm, REF: 15613
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1144-2025·2025-02-26

    Allura Xper FD20 Fluoroscopy Table Mattress Issue Causes Fall Risk

    Philips recalls Allura Xper FD20 fluoroscopy patient tables due to a mattress issue that may cause patients to fall during procedures.

    Product
    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1152-2025·2025-02-26

    Philips Allura Xper Patient Table Mattress Defect Fall Risk

    Philips is recalling the Allura Xper FD10C patient examination table due to a mattress defect that may allow patients to fall from the table. The device was distributed worldwide.

    Product
    Allura Xper FD10C; Catalog number: 722001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0211-2025·2025-02-05

    Prograf Tacrolimus Capsules Recall: Empty Capsules in Bottles

    Astellas Pharma recalls Prograf (tacrolimus) 0.5 mg capsules distributed nationwide due to empty capsules in bottles. Affected lot 0E3353D expires March 31, 2026.

    Product
    PROGRAF — PROGRAF (TACROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0428-2025·2025-02-05

    Lay's Classic Potato Chips recalled for undeclared milk allergen

    Frito Lay Inc. is recalling 6,344 bags of 13 oz. Lay's Classic Potato Chips distributed in Washington and Oregon due to an undeclared milk allergen that could cause allergic reactions.

    Product
    13 oz. Lay's Classic Potato Chips.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0454-2025·2025-02-05

    Sushi Rolls Recalled Due to Possible Salmonella Contamination

    GBC Food Services (Yummi Sushi) has recalled multiple sushi roll products due to possible Salmonella contamination. The affected products were distributed in Texas and have best-by dates of 11/30/2024.

    Product
    Vegetarian Roll UPC: 85375900869 Qty: 1 Tray, Net Wt: 6.1oz (174g) 11/22 to 11/29/2024 Vegetarian Roll (Brown Rice) UPC: 85694200824 Qty: 1 Tray, Net Wt: 6.1oz (174g) 11/22 to 11/29/2024 Mixed Vegetable Roll (Brown Rice) UPC: 85694200880 Net Wt: 7.1oz (202g) 11/22 to 11/29/2024 V
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0395-2025·2025-01-22

    Cucumber Spears Recalled Due to Potential Salmonella Contamination

    First Quality Produce is recalling Cucumber Spears in 5-lb trays due to potential Salmonella contamination. The recall affects distribution to 13 consignees in California.

    Product
    Cucumber Spear; 5-lb plastic trays Brand: First Quality Produce
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0425-2025·2025-01-22

    Wicklow Gold Cheddar Nettle & Chive Cheese recalled for possible Listeria contamination

    Abbey Specialty Foods is recalling Wicklow Gold Cheddar Nettle & Chive Cheese due to possible Listeria monocytogenes contamination. The product was distributed to Massachusetts, Colorado, and Ohio.

    Product
    Wicklow Gold Cheddar Nettle & Chive Cheese, 5.2 oz., plastic cryo-vac , 8 packages per case
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Devices)·Z-0830-2025·2025-01-22

    Impella RP Flex Devices Recalled Due to Optical Sensor Damage Risk

    Abiomed is recalling 2,364 units of the Impella RP Flex with SmartAssist due to risk of optical sensor damage from device interaction. Damage may cause temporary or permanent pump stop and loss of vital monitoring signals.

    Product
    Impella RP Flex with SmartAssist; Product Number: 1000323;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0887-2025·2025-01-22

    Life2000 Ventilation System battery charger defect causes device inoperability

    Baxter Healthcare is recalling the Life2000 Ventilation System due to a battery charger defect that can trigger an alarm, rendering the ventilator inoperable and unable to support patients' breathing.

    Product
    Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0884-2025·2025-01-22

    Welch Allyn Life 2000 Ventilator Battery Charger Defect Causes Inoperability

    The Welch Allyn Life 2000 Ventilator has a battery charger defect that could cause an alarm, rendering it inoperable. 187 units nationwide are affected in this FDA Class I recall.

    Product
    Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0825-2025·2025-01-22

    ALTRUA 2 DR Pacemaker Models S702 and S722 Safety Mode Risk

    Boston Scientific ALTRUA 2 DR Pacemakers may unexpectedly enter Safety Mode during normal operation due to high battery impedance, potentially affecting device functionality.

    Product
    ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0384-2025·2025-01-15

    Baker's Source Cornbread Mix Recalled for Undeclared Egg Allergen

    Baker's Source Traditional Cornbread Mix is being recalled due to undeclared egg allergen. The 210,960-pound recalled quantity was distributed across eight states and poses a risk to consumers with egg allergies.

    Product
    235214 Baker's Source Traditional Cornbread Mix Complete, 5 LB Bags, 30 LB Cases Foodservice Use, Human Consumption & mix with water and bake Shelf Stable Dry Mix, 1 Year Shelf Life
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0314-2025·2025-01-01

    Kirkland Signature Organic Eggs Recalled Due to Salmonella Risk

    Kirkland Signature Organic Eggs sold at Costco have been recalled due to potential Salmonella contamination. The recalled eggs were distributed to retail facilities in Alabama, Georgia, North Carolina, South Carolina, and Tennessee.

    Product
    Kirkland Signature ORGANIC EGGS PASTURE-RAISED 24 EGGS, GRADE A LARGE, NET WEIGHT 48OZ (3 LB) 1.36 kg, UPC 0 96619 10680 6, DISTRIBUTED BY: COSTCO WHOLESALE CORPORATION 730 LAKE DRIVE, ISSAQUAH, WA 98027
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-0299-2025·2024-12-25

    Crab Cheese Rangoon Frozen Appetizers Recalled for Undeclared Allergens

    Crab Cheese Rangoon frozen appetizers manufactured by SE Tampa Inc are recalled due to undeclared allergens: milk, soy, shellfish, and fish. Consumers with these allergies should not consume the product.

    Product
    Crab Cheese Rangoon, NET WT: 8 LB, 120 pieces of 30g / 3 Trays per master cardboard boxes, Keep Frozen, packaged in corrugated cardboard box.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0260-2025·2024-12-18

    Con Yeager Trail Bologna Meat Processing Kit recalled for undeclared wheat and soy

    Con Yeager Spice Company is recalling Trail Bologna Meat Processing Kits because they contain undeclared wheat and soy allergens. Affected consumers with allergies should not consume the product.

    Product
    Con Yeager Spice Company, Trail Bologna Meat Processing Kit, 17.88 Ounce pouches, UPC code 797442404137
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-0272-2025·2024-12-18

    Organic Broccoli Medley Recalled Due to E. coli O121 Contamination Risk

    4Earth Farms is recalling Organic Broccoli Medley packages due to potential E. coli O121:H19 contamination. The product was distributed across multiple states to retail and distribution centers.

    Product
    Organic Broccoli Medley, 4Earth Farms, Net Weight 12 oz (340 g) Washed and ready to prepare, Perishable keep refrigerated. Distributed by 4Earth Farms, LLC., Commerce, CA 92022 USA
    Category
    Food
    Distribution
    8 states
  • CriticalFDA (Food)·F-0278-2025·2024-12-18

    Broccoli medley recalled for potential E. coli O121:H19 contamination

    4Earth Farms is recalling 6,036 cases of broccoli medley due to potential contamination with E. coli O121:H19. The product was distributed to retailers and distribution centers across multiple states.

    Product
    Broccoli Medley, 4Earth Farms, Net Weight 12 oz (340 g) (6 pack/case) Washed and ready to prepare, Perishable keep refrigerated. Distributed by 4Earth Farms, LLC., Commerce, CA 92022 USA
    Category
    Food
    Distribution
    8 states