FACSLyric 3L12C Instrument RUO
Medical device recall Z-0749-2025. Published in FDA’s Enforcement Report on Jan 1, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 1, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 27 states named
- 139 power supplies how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181
139 power supplies, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Power supply part number 650781 with serial numbers beginning with V2309, V2318, and V2330 are impacted Catalog Number: 663518 UDI-DI code: 00382906635181 Instrument Serial Numbers / Power Supply Serial Numbers: MP6635180000004 V23180079…
Every code shown here, 1,992 characters
Power supply part number 650781 with serial numbers beginning with V2309, V2318, and V2330 are impacted Catalog Number: 663518 UDI-DI code: 00382906635181 Instrument Serial Numbers / Power Supply Serial Numbers: MP6635180000004 V23180079 MP6635180000008 V23180205 MP6635180000005 V23180222 MP6635180000006 V23180230 Z663518000594 V23180062 Z663518000529 V23300356 Z663518000526 V23300128 Z663518000470 V23180355 Z663518000471 V23180343 Z663518000456 V23090485 Z663518000433 V23090505 Z663518000402 V23090220 Z663518000165 UNK Z663518000196 UNK Z663518000214 UNK Z663518000338 V23090066 Z663518000342 V23090294 Z663518000339 V23090178 Z663518000349 V23090224 Z663518000350 V23090127 Z663518000357 V23090035 Z663518000343 V23090118 Z663518000346 V23090121 Z663518000352 V23090319 Z663518000360 V23090242 Z663518000355 V23090002 Z663518000359 V23090351 Z663518000340 V23090283 Z663518000337 V23090300 Z663518000335 V23090301 Z663518000361 V23090352 Z663518000362 V23090113 Z663518000347 V23090077 Z663518000336 V23090304 Z663518000341 V23090292 Z663518000365 V23090235 Z663518000358 V23090328 Z663518000353 V23090371 Z663518000382 V23090360 Z663518000369 V23090085 Z663518000380 V23090169 Z663518000351 V23090025 Z663518000348 V23090171 Z663518000356 V23090273 Z663518000378 V23090090 Z663518000345 V23090018 Z663518000367 V23090226 Z663518000385 V23090369 Z663518000376 V23090356 Z663518000379 V23090041 Z663518000354 V23090359 Z663518000384 V23090490 Z663518000386 V23090262 Z663518000388 V23090162 Z663518000387 V23090264 Z663518000364 V23090084 Z663518000389 V23090072 Z663518000381 V23090059 Z663518000375 V23090237 Z663518000390 V23090079 Z663518000377 V23090198 Z663518000383 V23090259 Z663518000444 V23180285 Z663518000391 V23090068 Z663518000373 V23090200 Z663518000372 V23090086 Z663518000445 V23090375 Z663518000442 V23180281 Z663518000374 V23090251 Z663518000441 V23180332 Z663518000370 V23090233 Z663518000440 V23180189 Z663518000463 V23180015 Z663518000449 V23090492 Z663518000446…
FDA’s list runs to 4,833 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia & Wisconsin. The countries of China, Costa Rica, Singapore, Thailand.
The states and territories these words name
27 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Kentucky
- Massachusetts
- Maryland
- Michigan
- Minnesota
- North Carolina
- Nebraska
- New Jersey
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Tennessee
- Texas
- Virginia
- Wisconsin
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 1, 2024.
- FDA classified it on Dec 23, 2024.
- FDA’s Enforcement Report published it on Jan 1, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Becton, Dickinson and Company, BD Bio Sciences, of Milpitas, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,833 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.