The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

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.

28726–28750 of 50488

  • HighFDA (Devices)·Z-1981-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues

    Arrow International is recalling 416,055 Pressure Injectable Multi-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PVH and ASK-15703-PNYP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1977-2018·2018-06-06

    Arrow Percutaneous Sheath Introducer Kits Recalled for Packaging Sterility Concerns

    Arrow International is recalling specific lots of Percutaneous Sheath Introducer Kits because unsealed packaging may compromise product sterility.

    Product
    Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps Safety Features (Recommended for use with 7 Fr. Catheters); Product Code: ASK-09907-SB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2042-2018·2018-06-06

    NordicNeuroLab Recalls nordicTumorEx 1.0 Software Due to Image Orientation Errors

    NordicNeuroLab AS is recalling 16 licenses of nordicTumorEx 1.0 software because a DICOM header error may cause incorrect image orientation labeling.

    Product
    nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·18170·2018-06-06

    GE Lighting Recalls LED Tube Lamps Due to Shock and Electrocution Hazards

    GE Lighting is recalling LED tube lamps sold at Lowe's because the pins can become energized during installation, posing electric shock and electrocution hazards.

    Product
    Cool White Universal T8/T12 LED tube lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1497-2018·2018-06-06

    Hickory Harvest Island Fruit Mix Recalled for Listeria Risk

    Ohio Hickory Harvest Brand Products Inc. is recalling Hickory Harvest Island Fruit Mix due to Listeria monocytogenes found in a product stored in the same bin.

    Product
    Hickory Harvest Island Fruit Mix NET WT 9 oz (255g) Distributed by: Hickory Harvest Foods, Akron, OH 44319 UPC 0-36232-06052-9
    Category
    Food
    Distribution
    33 states
  • HighFDA (Devices)·Z-1931-2018·2018-06-06

    Medline Sterile Needle Counter Recall Due to Packaging Seal Creep

    Medline is recalling sterile needle counters because packaging seal creep may compromise sterility. The product is used to count surgical sharps.

    Product
    MEDLINE Sterile* Needle Counter, 100Ct. Double Magnet / Foam Block, reorder: DYNJNC100F Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2029-2018·2018-06-06

    Arrow International Recalls Sheath Adapters Due to Compromised Sterility

    Arrow International is recalling Sheath Adapters with Cath-Gard shields because unsealed packaging may compromise product sterility.

    Product
    Sheath Adapter with Cath-Gard¿ Catheter Contamination Shield for use with 4 - 7 Fr. Catheters; Product codes: SA-09847
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·18746·2018-06-06

    Vernier Circuit Board 2 Recalled Due to Burn Hazard

    Vernier Software & Technology is recalling Circuit Board 2 units because overheating switches can cause burns. About 4,200 units were sold between 2015 and 2018.

    Product
    Vernier Circuit Board 2
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2025-2018·2018-06-06

    Arrow PICC Catheters Recalled Due to Potential Sterility Compromise

    Arrow International Inc. is recalling 416,055 PICC catheters because unsealed packaging may have compromised product sterility.

    Product
    Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS, PR-44063-BAS, PR-45041-BAS, PR-45052-BAS, PR-45063-BAS, PR-45541-BAS,PR-45541-HPHNL, PR-45541-HPHNM, PR-45552-BAS, PR-45552-HPHNL,PR-45552-HPHNM, PR-45563-BAS, PR-45563-HPHNL, PR-45563-HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1521-2018·2018-06-06

    Chocolate Bar Recalled for Undeclared Wheat Allergen

    JJBL LLC is recalling The Most Awesome Chocolate Bar EVER due to undeclared wheat. The product was distributed in California, Oregon, and Washington.

    Product
    The Most Awesome Chocolate Bar EVER, packaged individually in a 1.5 oz bar. The UPC is 8 55966 00178 9. The label is read in parts: "***Lillie Belle Farms***The Most Awesome Chocolate Bar EVER! ***Ingredients: organic milk and dark chocolate (organic cocoa mass, organic…
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·18V372000·2018-06-05

    Manac Recalls Steel Flatbed and Dropdeck Trailers Due to Lashing Chain Defect

    Manac is recalling 2013-2018 Steel Dropdeck, 2017 Extendable Steel Dropdeck, and 2018 Steel Flatbed trailers because lashing chains may break, allowing cargo to slide or tip.

    Product
    MANAC — MANAC STEEL DROPDECK, EXTENDABLE STEEL DROPDECK, STEEL FLATBED
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18172·2018-06-05

    Keyera Energy Recalls Propane Gas Due to Fire and Explosion Hazards

    Keyera Energy is recalling under-odorized propane gas in Texas and Louisiana due to fire and explosion risks. Consumers should contact suppliers for a free inspection.

    Product
    Propane (LP) gas
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V370000·2018-06-04

    Audi Recalls A6, A7, S6, S7, RS 7 for Air Bag Sensor Defect

    Volkswagen Group of America is recalling 139,249 Audi vehicles because a faulty seat sensor may prevent the front passenger air bag from deploying in a crash.

    Product
    AUDI — AUDI A7, A6, RS 7, S6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1927-2018·2018-05-30

    Getinge Recalls ALM XTEN Surgical Lights Due to Broken Spring Arms

    Getinge is recalling 667 ALM XTEN Surgical Lights because spring arms may crack and break, causing light heads to separate.

    Product
    ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0825-2018·2018-05-30

    Mylan Recalls Loxapine Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is voluntarily recalling 11,650 bottles of Loxapine Capsules 50 mg due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1921-2018·2018-05-30

    Smith & Nephew Recalls Anthology Hip Stems Due to Manufacturing Defect

    Smith & Nephew is recalling 13 units of Anthology hip prosthesis stems because they were manufactured with an undersized taper length.

    Product
    smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1916-2018·2018-05-30

    Synthes Torque Limiting Handle Recalled Due to Premature Rusting

    Synthes (USA) Products LLC is recalling 50 Torque Limiting Handles because high-carbon ball bearings may rust prematurely, causing functional degradation.

    Product
    Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1929-2018·2018-05-30

    Edwards IntraClude Intra-Aortic Occlusion Device Recalled for Potential Leak

    Edwards Lifesciences is recalling 3,052 IntraClude Intra-Aortic Occlusion Devices due to a possible leak at the distal open end of the strain relief.

    Product
    Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100. Designed to occlude the ascending aorta.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Food)·F-1494-2018·2018-05-30

    Grand Canyon Foods Recalls Prickly Pear Popcorn for Undeclared Allergens

    Grand Canyon Foods is recalling Southwestern Gourmet Prickly Pear Popcorn because it contains Yellow 5 and soy lecithin that were not declared on the label.

    Product
    Southwestern Gourmet Prickly Pear Popcorn Grand Canyon Foods, Phoenix, AZ
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-1896-2018·2018-05-30

    Madison Polymeric Engineering Recalls Endoscopic Cleaning Pads Due to Microbial Contamination

    Madison Polymeric Engineering is recalling First Step Endoscopic Cleaning Pads because they exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.

    Product
    First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1930-2018·2018-05-30

    Siemens Biograph Horizon PET/CT Systems Recalled for Firmware Issue

    Siemens Medical Solutions is recalling 14 Biograph Horizon PET/CT systems due to a firmware issue that may cause waveform sampling errors during cardiac gating examinations.

    Product
    Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    0 states