The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

22426–22450 of 32171

  • SevereFDA (Devices)·Z-2318-2015·2015-08-12

    Cook Inc. Recalls Beacon Tip Royal Flush Plus High-Flow Catheters

    Cook Inc. is recalling Beacon Tip Royal Flush Plus High-Flow Catheters due to reports of tip splits or separation that may cause loss of function or complications.

    Product
    Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1297-2015·2015-08-12

    Apothecary Shoppe Recalls SIU-Phent Injection Due to Sterility Concerns

    The Apothecary Shoppe LLC is recalling SIU-Phent .4 mg/PGE1 20 mcg/mL Injection due to a lack of documentation for environmental monitoring during production.

    Product
    SIU-Phent .4 mg/PGE1 20 mcg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1802-97
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-2909-2015·2015-08-12

    Osamu Recalls Frozen Tuna Chunks Due to Potential Salmonella Contamination

    Osamu Corporation is recalling raw frozen tuna chunks from Indonesia due to potential Salmonella contamination. The recall covers 625 cases distributed across 15 U.S. states and D.C.

    Product
    Raw Frozen Tuna Chunks Product of Indonesia. The bulk frozen tuna products can be identified from the Purchase Order Number (PO#) printed on each product carton box end panel.
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Food)·F-2934-2015·2015-08-12

    Maya Brand Cashew Split Recalled for Potential Salmonella Contamination

    Maya Overseas Foods is recalling approximately 8,000 lbs of Maya brand Cashew Split due to potential Salmonella contamination. The product was distributed in New York, New Jersey, Pennsylvania, Connecticut, Massachusetts, and Florida.

    Product
    A Taste of the East maya brand Cashew Split, packaged and sold in various sizes: (a) Net Wt. 7oz. (198g) UPC 0 20843 23038 9, (b) Net Wt. 14oz. (396g) UPC 0 20843 23071 6, (c) Net Wt. 28oz. (793g) UPC 0 20843 23032 7; (d) NET WT: 5 lbs. (2.25 kg) UPC 0 20843 23030 3 --- Packed…
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2325-2015·2015-08-12

    Medtronic Passive Biopsy Needle Kit Recalled for Adhesive Defect

    Medtronic is recalling 1,415 Passive Biopsy Needle Kits because adhesive failure may cause the sphere assembly to move, leading to inaccurate navigation during brain biopsies.

    Product
    Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2326-2015·2015-08-12

    Aesculap S4C Occiput Torque Wrench Recalled Due to Reassembly Defect

    Aesculap is recalling 10 S4C Occiput Torque Wrenches because improper reassembly after reprocessing caused a screw to break during implantation.

    Product
    S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a defined torque 2.8 Nm for tightening the clamping screw in the screw head/hook head/occipital plate/transverse connector and other connectors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2317-2015·2015-08-12

    Cook Inc. Recalls Beacon Tip Torcon NB Advantage Catheters

    Cook Inc. is recalling Beacon Tip Torcon NB Advantage Catheters due to reports of tip splits or separation, which may cause loss of function or complications.

    Product
    Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2324-2015·2015-08-12

    Medtronic Passive Biopsy Needle Kit Recalled for Adhesive Defect

    Medtronic is recalling 1,415 Passive Biopsy Needle Kits because compromised adhesive may cause the sphere assembly to move, leading to inaccurate navigation during brain biopsies.

    Product
    Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2912-2015·2015-08-12

    Osamu Recalls Raw Frozen Saku Tuna Due to Salmonella Risk

    Osamu Corporation is recalling raw frozen saku tuna products from Indonesia due to potential Salmonella contamination. The recall covers bulk frozen tuna distributed to 15 U.S. states and D.C.

    Product
    Raw Frozen Saku Tuna Product of Indonesia. The bulk frozen tuna products can be identified from the Purchase Order Number (PO#) printed on each product carton box end panel.
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Drugs)·D-1296-2015·2015-08-12

    Apothecary Shoppe Recalls Papaverine and Phentolamine Injection Due to Sterility Concerns

    The Apothecary Shoppe is recalling specific lots of SIU-Papav/Phentol 30/1 mg/mL Injection due to a lack of documentation for environmental monitoring during production.

    Product
    SIU-Papav/Phentol 30/1 mg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1295-2015·2015-08-12

    Apothecary Shoppe Recalls Papaverine and Phentolamine Injection Due to Sterility Concerns

    The Apothecary Shoppe LLC is recalling specific vials of Papaverine and Phentolamine Injection due to a lack of documentation confirming proper environmental monitoring during production.

    Product
    SIU-Papav/Phent 24/1 mg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1461-57
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-2939-2015·2015-08-12

    Wish-Bone Ranch Dressing Recalled for Undeclared Eggs

    Pinnacle Foods is recalling Wish-Bone Ranch Dressing because it contains undeclared eggs, posing a risk to consumers with egg allergies.

    Product
    Wish-Bone Ranch Dressing Net. Wt. 24 oz. Distributed by Pinnacle Foods Group USA LLC Cherry Hill, NJ 08003-3620 UPC 0-41321-00661-6
    Category
    Food
    Distribution
    30 states
  • SevereFDA (Food)·F-2913-2015·2015-08-12

    Osamu Recalls Raw Frozen Tuna Loin Due to Salmonella Risk

    Osamu Corporation is recalling raw frozen tuna loin products from Indonesia due to potential Salmonella contamination. The recall affects bulk frozen tuna distributed to 15 U.S. states and D.C.

    Product
    Raw Frozen Tuna Loin Product of Indonesia. The bulk frozen tuna products can be identified from the Purchase Order Number (PO#) printed on each product carton box end panel.
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Food)·F-2917-2015·2015-08-12

    La Jalpita Walnut Bolis Recalled for Undeclared Milk

    Paleteria La Jalpita is recalling 90 units of La Jalpita brand walnut bolis in Oregon and Washington due to undeclared milk.

    Product
    Walnut bolis (tube), La Jalpita brand, 3.5 fl. oz. No UPC. This product contains artificial flavoring instead of real walnut.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2264-2015·2015-08-12

    Medtronic Recalls EnVeo R Loading Systems Due to Particulate Presence

    Medtronic is recalling EnVeo R Loading Systems because of the presence of particulate. The recall affects 6,912 units worldwide, including 540 in the US.

    Product
    EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2910-2015·2015-08-12

    Osamu Recalls Raw Frozen Ground Tuna Due to Salmonella Risk

    Osamu Corporation is recalling raw frozen ground tuna from Indonesia due to potential Salmonella contamination. The products were distributed to 15 states and DC.

    Product
    Raw Frozen Ground Tuna Product of Indonesia. The bulk frozen tuna products can be identified from the Purchase Order Number (PO#) printed on each product carton box end panel.
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Food)·F-2930-2015·2015-08-12

    Charles Products Recalls Shot Glasses Exceeding Lead and Cadmium Limits

    Charles Products Inc. is recalling specific shot glasses because testing revealed lead and cadmium levels exceeding FDA guidance.

    Product
    Shot glasses with decorative artwork that reads Blue: "Who's Your Candy?!" SKU # 835989 Green: "Eye Candy" SKU # 835990 Red: "Hard on the Outside Sweet on the Inside" SKU # 835986
    Category
    Consumer Product
    Distribution
    2 states
  • SevereFDA (Food)·F-2929-2015·2015-08-12

    Charles Products Recalls Pint Glasses Exceeding Lead and Cadmium Limits

    Charles Products Inc. is recalling pint-sized glasses with decorative artwork because testing revealed lead and cadmium levels exceeding FDA guidance.

    Product
    Pint sized glasses with decorative artwork that reads Blue: "Who's Your Candy?!" SKU # 835992 Green: "Eye Candy" SKU # 835993 Red: "Hard on the Outside Sweet on the Inside" SKU # 835991
    Category
    Consumer Product
    Distribution
    2 states
  • SevereNHTSA·15V508000·2015-08-12

    Jeep Renegade Recall for Radio Software Vulnerability

    Chrysler is recalling 2015 Jeep Renegade vehicles to fix a radio software vulnerability that could allow unauthorized remote control of vehicle systems.

    Product
    JEEP — JEEP RENEGADE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V505000·2015-08-11

    Mercedes-Benz Recalls 2015-2016 Models for Engine Compartment Fire Risk

    Mercedes-Benz is recalling specific 2015 and 2016 models because a damaged seal may fall into the engine bay, increasing the risk of a fire.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ E400, CLS550, CLS400, E63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V504000·2015-08-11

    Mitsubishi Fuso Trucks Recalled for Brake Pad Shim Corrosion

    Mitsubishi Fuso is recalling certain FEC52, FEC72, and FEC92 trucks because brake pad shims may rust, increasing stopping distance and crash risk.

    Product
    MITSUBISHI FUSO — MITSUBISHI FUSO FEC52, FEC92, FEC72
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V500000·2015-08-10

    GM Recalls 2010 Chevrolet Cobalt Vehicles for Air Bag Wiring Defect

    General Motors is recalling 2010 Chevrolet Cobalt vehicles because a misrouted wiring harness may disable the driver-side curtain air bag, increasing injury risk in a crash.

    Product
    CHEVROLET — CHEVROLET COBALT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V503000·2015-08-10

    Goshen Coach Recalls 2014-2015 Vans Due to Loose Seat Bolts

    Goshen Coach is recalling 1,494 model year 2014-2015 vans because driver and passenger seat bolts may not be properly tightened, increasing injury risk in a crash.

    Product
    GOSHEN — GOSHEN PACER LS, COMMANDER, CONNECTION, SENTINEL UC
    Category
    Vehicle
    Distribution
    Distributed nationwide