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Medivators Hookup (REF 28014)Recalls & reported problems

Medivators Inc. · Hookup, OPTIM Leak Tester connects MEDIVATORS reprocessing equipment to endoscopes or related accessories. · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K102996, K172677); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Nov 13, 2023Open, Classified

    Identification label on affected hookups could become illegible over time due to the label's ink coming off. This may potentially prevent users from being able to effectively identify the hookup and may ultimately result in postponement of patient procedures.

    Z-0617-2024 · Root cause: Process control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102996, K172677. One submission often covers many models, so check the product and lot details in each record.

  • Z-2536-2024 · Jun 13, 2024 · Open, Classified
    Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Au
  • Z-2538-2024 · Jun 13, 2024 · Open, Classified
    Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru
  • Z-2537-2024 · Jun 13, 2024 · Open, Classified
    Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru

Other Accessories, cleaning, for endoscope devices

All Accessories, cleaning, for endoscope devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.