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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78950

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

Open FDA event record

Event summary

Timeline bucket
June 27, 2017
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

7 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 7

Safety-Deluxe Lumbar Puncture Tray, Catalog # 974 Product Usage: Surgical procedure

Z-0540-2018
Recall number
Z-0540-2018
Initiated
June 27, 2017
Classification
Class II
Status
Terminated
Quantity
470 cases

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign matter

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

BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.

Code information

Lot Number/Expiration Date: 1) 1610300/Expiration Date 03/01/2019; 2) 1610503/Expiration Date 05/30/2019; 3) 1710059/Expiration Date: 09/30/2019; 4) 1610383/Expiration Date: 02/28/2019; 5) 1610463/Expiration Date: 05/30/2019; 6) 1610215/Expiration Date: 02/01/2019; 7) 1610114/Expiration Date: 11/01/2018; 8) 1610044/Expiration Date: 06/01/2018;

Distribution pattern

US Nationwide Distribution

device · product 2 of 7

Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977 Product Usage: Surgical procedure

Z-0541-2018
Recall number
Z-0541-2018
Initiated
June 27, 2017
Classification
Class II
Status
Terminated
Quantity
28 cases

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign matter

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

BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.

Code information

Lot Numbers/Expiration Dates: 1) 1610197/Expiration Date: 12/01/2018; 2) 1610277/Expiration Date: 03/01/2019

Distribution pattern

US Nationwide Distribution

device · product 3 of 7

Safety-Deluxe Lumbar Puncture Tray, Catalog # 975 Product Usage: Surgical procedure

Z-0542-2018
Recall number
Z-0542-2018
Initiated
June 27, 2017
Classification
Class II
Status
Terminated
Quantity
82 cases

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign matter

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

BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.

Code information

Lot Numbers/Expiration Dates: 1) 1610197/Expiration Date: 12/01/2018; 2) 1610204/Expiration Date: 02/01/2019; 3) 1610075/Expiration Date: 06/01/2018; 4) 1610431/Expiration Date: 05/30/2019; 5) 1610246/Expiration Date: 02/01/2019; 6) 1610204/Expiration Date: 02/01/2019

Distribution pattern

US Nationwide Distribution

device · product 4 of 7

Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle and Aspiration Needle Sterile, Catalog # 985 Product Usage: Surgical procedure

Z-0543-2018
Recall number
Z-0543-2018
Initiated
June 27, 2017
Classification
Class II
Status
Terminated
Quantity
5 cases

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign matter

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

BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.

Code information

Lot Numbers/Expiration Dates: 1) 1720047/Expiration Date: 02/20/2018

Distribution pattern

US Nationwide Distribution

device · product 5 of 7

Laceration Tray, Catalog # 1892R1 Product Usage: Surgical procedure

Z-0544-2018
Recall number
Z-0544-2018
Initiated
June 27, 2017
Classification
Class II
Status
Terminated
Quantity
75 cases

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign matter

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

BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.

Code information

Lot Numbers/Expiration Dates: 1) 1730650/Expiration Date: 10/30/2021; 2) 1630921/Expiration Date: 11/02/2020; 3) 1631124/Expiration Date: 10/30/2020; 4) 1631386/Expiration Date: 05/30/2021; 5) 1631679/Expiration Date: 05/30/2021

Distribution pattern

US Nationwide Distribution

device · product 6 of 7

Lumbar Puncture Tray, Catalog # 1862 Product Usage: Surgical procedure

Z-0545-2018
Recall number
Z-0545-2018
Initiated
June 27, 2017
Classification
Class II
Status
Terminated
Quantity
1037 in total

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign matter

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

BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.

Code information

Lot Numbers/Expiration Dates: 1) 1710206/Expiration Date: 05/30/2022; 2) 1710040/Expiration Date: 01/30/2022; 3) 1610536/Expiration Date: 12/30/2021; 4) 1610423/No Expiration Date; 5) 1610351/No Expiration Date; 6) 1610219/No Expiration Date; 7) 1610090/No Expiration Date

Distribution pattern

US Nationwide Distribution

device · product 7 of 7

Safety Deluxe Bone Marrow Biopsy/Aspiration Tray, Catalog # 986 Product Usage: Surgical procedure

Z-0546-2018
Recall number
Z-0546-2018
Initiated
June 27, 2017
Classification
Class II
Status
Terminated
Quantity
15 cases

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign matter

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

BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.

Code information

Lot Numbers/Expiration Dates: 1) 1620888/Expiration Date: 12/30/2017 2) 1620367/Expiration Date: 09/01/2017

Distribution pattern

US Nationwide Distribution