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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75746

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 15, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables

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

3 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 3

CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # D190549.

Z-0894-2017
Recall number
Z-0894-2017
Initiated
November 15, 2016
Classification
Class II
Status
Terminated
Quantity
US: 14 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.

Code information

Lot Number 1230783, Exp. Date February 2017; Lot Number 1330825, Exp. Date April 2018

Distribution pattern

PA, FL, VA

device · product 2 of 3

BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.

Z-0895-2017
Recall number
Z-0895-2017
Initiated
November 15, 2016
Classification
Class II
Status
Terminated
Quantity
US: 35 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.

Code information

Lot Number 1230323, Exp. Date December 2016; Lot Number 1230387, Exp. Date December 2016; Lot Number 1231616, Exp. Date December 2016

Distribution pattern

PA, FL, VA

device · product 3 of 3

SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Listing # A343147

Z-0896-2017
Recall number
Z-0896-2017
Initiated
November 15, 2016
Classification
Class II
Status
Terminated
Quantity
US: 82 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.

Code information

Lot Number 1530330, Exp. Date November 2017; Lot Number 1530241, Exp. Date September 2017; Lot Number 1530095, Exp. Date September 2017; Lot Number 1431734, Exp. Date August 2017; Lot Number 1431066, Exp. Date May 2017

Distribution pattern

PA, FL, VA