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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86040

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
June 26, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Boss Instruments, Ltd.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2767-2020
Recall number
Z-2767-2020
Initiated
June 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Boss Instruments, Ltd.
Quantity
96 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Numbers: 00351415,00425391, 00374008,07702195, 08801812, 08802271, 00383211,00384765,00418258, 08804204,09900093, 09900383

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of CA, TN, TX and the countries of England, Japan, New Zealand, South Africa, South Korea, Taiwan.