Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80388

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

Open FDA event record

Event summary

Timeline bucket
May 16, 2018
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Becton, Dickinson and Company, BD Biosciences

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

BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The firm name on the label is Becton, Dickinson and Company, BD Biosciences, San Jose, CA. The Loader offers various settings to resuspend and mix samples. It can draw from 12 x 75-mm tubes in 30- and 40-tube racks. A barcode reader verifies the ID on tube racks and individual tubes in 30- tube racks. A built-in imaging system provides safety checks, such as verifying the correct rack type and tube layout, and ensures the tubes were loaded correctly.

Z-2598-2018
Recall number
Z-2598-2018
Initiated
May 16, 2018
Classification
Class III
Status
Terminated
Quantity
8 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use.

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 solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use.

Code information

Serial #2662879000001, UDI (01)00382906628794(11)170915(21)Z662879000001; Serial #2662879000002, UDI (01)00382906628794(11)170915(21)Z662879000002; Serial #2662879000003, UDI (01)00382906628794(11)170915(21)Z662879000003; Serial #2662879000004, UDI (01)00382906628794(11)170915(21)Z662879000004; Serial #2662879000009, UDI (01)00382906628794(11)170915(21)Z662879000009; Serial #2662879000010; UDI (01)00382906628794(11 )170915(21)Z662879000010; Serial #2662879000011; UDI (01)00382906628794(11)170915(21)Z662879000011; and Serial #2662879000012, UDI (01)00382906628794(11)170915(21)Z662879000012.

Distribution pattern

US Distribution was made to FL, KS, KY, MA, NJ, and SD.