The Recall Desk

Hazard

Class Ii recalls

1,428 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,428
Critical
0
Severe
0
Most recent
2026-07-08

Of the 1,428 class ii recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all class ii recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1351–1375 of 1428

  • HighFDA (Devices)·Z-2098-2025·2025-07-16

    Nuclear medicine systems may show unintended radial detector motion during scans

    Varicam, Millennium VG, Millennium VG Hawkeye and Discovery VH nuclear medicine systems are being recalled because unintended radial detector motion may occur without the correct gantry software version. 21 units affected.

    Product
    Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2101-2025·2025-07-16

    O-arm O2 imaging system gantry support may have been damaged

    The O-arm O2 Imaging System is being recalled because a mechanical component supporting the gantry to the support structure may have been damaged during manufacture. 3 units affected.

    Product
    O-arm O2 Imaging System. Mobile X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2110-2025·2025-07-16

    Alcon Custom Pak surgical kits may have damaged lidding compromising sterility

    Alcon Custom Paks, customer-designed sterile surgical kits, are being recalled because some units within specific lots may have been damaged during manufacture in the lidding area. 15,557 kits affected.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intende
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2108-2025·2025-07-16

    Alcon Constellation vitrectomy packs may have damaged lidding compromising sterility

    Alcon Constellation Vision System Vitrectomy Procedure Paks are being recalled because some units within specific lots may have been damaged during manufacture in the lidding area. 198,205 units affected.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constella
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0258-2025·2025-07-16

    Ghouribeh date rolls recalled over undeclared wheat, soy and sesame

    C Sweet Ghouribeh Rolls with date, sesame and pistachios are being recalled because wheat, soy and sesame are undeclared. 30 units are affected.

    Product
    C Sweet Ghouribeh Rolls with date, sesame, & pistachios 10 oz., UPC 642896991132
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2105-2025·2025-07-16

    VersaCross transseptal sheath kits may have a punctured sterile barrier pouch

    VersaCross Transseptal Sheath Kits are being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units affected.

    Product
    VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J Used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, includ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2106-2025·2025-07-16

    Torflex transseptal guiding sheath kits may have a punctured sterile pouch

    Torflex Transseptal Guiding Sheath Kits are being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units affected.

    Product
    Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG Used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2104-2025·2025-07-16

    VersaCross RF wire lots may have a punctured sterile barrier pouch

    The VersaCross RF Wire is being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units are affected.

    Product
    VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized in Japan only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0513-2025·2025-07-16

    Erin's Faces mineral sunscreen recalled over manufacturing practice deviations

    Erin's Faces Mineral SPF 32 sunscreen is being recalled because of cGMP deviations. 54 tubes are affected.

    Product
    Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Zinc Oxide, 3 FL OZ/ 85 mL per bottle, Made in USA for Erin's Faces, Millburn, NO 07041. NDC: 73369-1401-1
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2107-2025·2025-07-16

    Preat Astra dental analogs have rotational feature 180 degrees off

    Preat Astra EV-compatible 4.2 mm Digital Analogs are being recalled because a manufacturing error left the digital analog rotational feature 180 degrees off. 44 units are affected.

    Product
    Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0234-2025·2025-07-16

    Organic red and green cabbage recalled over reach truck fluid contamination

    Organic red and green cabbage is being recalled because it may be contaminated with fluid from a reach truck. The action covers 213 cases in total.

    Product
    1. WLD HRVST OG2 RED CABBAGE 2. USA/MX OG2 RED CABBAGE 3. USA ORGC GRN CABBAGE 4. WLD HRVST OG2 GREEN CABBAGE
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0515-2025·2025-07-16

    In Your Face tinted mineral sunscreen recalled over manufacturing practice deviations

    In Your Face Mineral Tint SPF 31 tinted sunscreen is being recalled because of cGMP deviations. 76 bottles are affected.

    Product
    In Your Face Mineral Tint SPF 31, Zinc Oxide 25%, Tinted Sunscreen Broad Spectrum UVA & UVB chemical free, Organic Ingredients, Biodegradable & Baby Safe, 50 mL - 1.7 fl oz per bottle, Manufactured for IN YOUR FACE Skin Care, Belleair Bluffs, FL, Made in USA, NDC: 73369-1601-1
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Food)·H-0235-2025·2025-07-16

    Organic bok choy recalled over possible reach truck fluid contamination

    Organic bok choy and organic baby bok choy are being recalled because they may be contaminated with fluid from a reach truck. The action covers 213 cases in total.

    Product
    1. USA ORGC BOK CHOY 2. USA/MEX OG2 BABY BOKCHOY
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2099-2025·2025-07-16

    Canturio smart tibial stem extensions recalled over an incorrect product label

    Canturio Smart Extension CSE Implants are being recalled due to a labeling error, with the product incorrectly labeled. 106 units are affected.

    Product
    Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics fo
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0514-2025·2025-07-16

    GreenScreen zinc oxide sunscreen recalled over manufacturing practice deviations

    GreenScreen organic zinc oxide sunscreen SPF 32 is being recalled because of cGMP deviations. 174 tubes are affected.

    Product
    GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Sunscreen, Organic Ingredients, Fragrance Free, Biodegradable, Chemical Free, Non-Nano, Baby Safe, Original, SPF 32, Totally Green personal care, Zinc Oxide USP 25%, 3.4 FL OZ/115 G Tube, NDC: 73369-0001-1
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Food)·H-0222-2025·2025-07-16

    Red Delicious, Gala and organic apples recalled over reach truck fluid

    A range of apples, including Red Delicious, Gala, Granny Smith and Fuji, is being recalled because they may be contaminated with fluid from a reach truck. 213 cases in total.

    Product
    1. USA APLS RED DEL TOTE 2. USA APLE RED DEL 80CT 3. DOMESTIC APPLE GALA TOTES 4. USA APPLES GALA 80CT 5. WLD HRVST OG2 WAXF GRNY SMTH 6. WLD HRVST OG2 WAXF FUJI 7. WLD HRVST OG2 WAXF GALA 8. WLD HRVST OG2 WAXF PINK LADY 9. WA OG1 HNYC
    Category
    Food
    Distribution
    5 states