🔍 RecallPedia

TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in mammography.

Class I - Dangerous
🏥 Medical Devices Recalled: June 13, 2018 Beekley Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    REF 782 - Lot Numbers: 05311801 05211801 02221801 04181802 03051801 03071802 04181804 05081801 03131801 02121801 03301802 05141801 03141801 05101801 03271801 05161801 02161801 03021802 04111801 05011801 05171802 02211801 04051802 04271801 04251801 05161802 03141802 05181801 04121801 05221802 04161802 04171801 04181803 05301802 04241802 05011802 02271802 02271803 02071802 02261802 02261803 05291803 REF 782S - Lot Numbers: 02221801 03271801 04121801 REF 783 - Lot Numbers: 04131801 03071801 02281801 03121801 05151801 04101801 05041801 03021801 05181803 02081801 03261801 05221801 02061801 04181801 04201801 05071801 03161801 04061801 05181802 04231802 03091802 03171801 REF 783S - Lot Numbers: 02221801 04021801 REF 784 - Lot Numbers: 05231801 03061801 02261801 03211801 02141801 03211802 05091801 04261802 REF 784S - Lot Numbers: 02221801 04021801 04121801 REF 785 Lot Numbers: 05111801 04191801 REF 785S Lot Numbers: 04021801 04121801
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Beekley Corporation
Reason for Recall:
There is a potential for imaging artifact to mimic calcifications on patient's mammograms
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in mammography.

Product Codes/Lot Numbers:

REF 782 - Lot Numbers: 05311801 05211801 02221801 04181802 03051801 03071802 04181804 05081801 03131801 02121801 03301802 05141801 03141801 05101801 03271801 05161801 02161801 03021802 04111801 05011801 05171802 02211801 04051802 04271801 04251801 05161802 03141802 05181801 04121801 05221802 04161802 04171801 04181803 05301802 04241802 05011802 02271802 02271803 02071802 02261802 02261803 05291803 REF 782S - Lot Numbers: 02221801 03271801 04121801 REF 783 - Lot Numbers: 04131801 03071801 02281801 03121801 05151801 04101801 05041801 03021801 05181803 02081801 03261801 05221801 02061801 04181801 04201801 05071801 03161801 04061801 05181802 04231802 03091802 03171801 REF 783S - Lot Numbers: 02221801 04021801 REF 784 - Lot Numbers: 05231801 03061801 02261801 03211801 02141801 03211802 05091801 04261802 REF 784S - Lot Numbers: 02221801 04021801 04121801 REF 785 Lot Numbers: 05111801 04191801 REF 785S Lot Numbers: 04021801 04121801

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2832-2018

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