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FDA Devices recall · Reported August 8, 2018

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 corre

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

Recall #
Z-2598-2018
Affected scope
8 devices
Initiated
May 16, 2018
Compiled from official public sources by the editorial team.
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Becton, Dickinson and Company, Bd Biosciences recalled BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Un… - a low-severity action.

BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Un… was recalled by Becton, Dickinson and Company, Bd Biosciences in August 8, 2018. Reason: The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader en…. Check the official notice for the remedy. Verify recall #Z-2598-2018 with the FDA Devices before acting.

The recall

Becton, Dickinson and Company, Bd Biosciences issued this low-severity FDA Devices recall-The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader en….

Low
severity level
8 units
affected scope
Class III
classification
August 8, 2018
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2598-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-2598-2018) was formally reported on August 8, 2018, with the manufacturer initiating the action on May 16, 2018. It is classified under Low severity (Class III), with a current status of Terminated. Becton, Dickinson and Company, Bd Biosciences is listed as the recalling firm, operating out of San Jose, CA. Federal records list the affected scope as 8 devices.

The documented reason for this recall is: The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use. Distribution data in the federal record shows the product reached: US Distribution was made to FL, KS, KY, MA, NJ, and SD.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 40,322 medical devices recalls on record

-1,00001,0002,0003,0004,000 20052008201120142017202020232026 1,248
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Low

Affected scope

8 devices

Related Recalls

6

3 from same agency

Product description

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.

Reason for recall

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

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Low (Class III)
Status Terminated
Recall number Z-2598-2018
Date reported August 8, 2018
Date initiated May 16, 2018
Recalling firm Becton, Dickinson and Company, Bd Biosciences
Firm location San Jose, CA
Affected scope 8 devices
Distribution US Distribution was made to FL, KS, KY, MA, NJ, and SD.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

8 devices units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-2598-2018) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
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.. Recalled by Becton, Dickinson and Company, Bd Biosciences. Units affected: 8 devices.
Why was this product recalled?
The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 8, 2018. Severity: Low. Recall number: Z-2598-2018.
Where was the recalled product distributed?
Distribution: US Distribution was made to FL, KS, KY, MA, NJ, and SD..
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-2598-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 8, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.