Reported Aug 12, 2020 · Terminated

BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic…

Boss Instruments, Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Boss Instruments, Ltd. · 104 Sommerfield Dr · Zion Crossroads, VA · 22942-7009

Is this the product you have?

  • BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503
  • and 51-2503 - Product UsageEndoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and pulled through the interior of the endoscope to remove debris
Lot codes and dates
  • Lot Numbers
    • 00351415
    • 00425391
    • 00374008
    • 07702195
    • 08801812
    • 08802271
    • 00383211
    • 00384765
    • 00418258
    • 08804204
    • 09900093
    • 09900383
Amount recalled
96 devices

Where it was sold

Why it was recalled

The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 20, 2021 · Data as of Sep 19, 6:15 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.