BD Alaris System
Medical device recall Z-2882-2020. Published in FDA’s Enforcement Report on Sep 16, 2020.
- FDA Class I
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 Sep 16, 2020. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- 54 states named in where it went
- 180,186 parts & devices 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 I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in delays in infusion, under-infusion, or over-infusion.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652
180,186 parts & devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Device Model/Serial Number: Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652: All Kits; PCA Module Model 8120: PCA (8120) 14217746 PCA (8120) 14259835 PCA (8120) 13063333 PCA (8120) 14231894 PCA (8120) 14231522 PCA (8120) 14232093…
Every code shown here, 1,998 characters
Device Model/Serial Number: Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652: All Kits; PCA Module Model 8120: PCA (8120) 14217746 PCA (8120) 14259835 PCA (8120) 13063333 PCA (8120) 14231894 PCA (8120) 14231522 PCA (8120) 14232093 PCA (8120) 14373709 PCA (8120) 12334465 PCA (8120) 13638955 PCA (8120) 13638959 PCA (8120) 14231764 PCA (8120) 14232010 PCA (8120) 14567433 PCA (8120) 14231895 PCA (8120) 14217150 PCA (8120) 14217736 PCA (8120) 14217764 PCA (8120) 14218525 PCA (8120) 14218830 PCA (8120) 14217763 PCA (8120) 13406723 PCA (8120) 13078712 PCA (8120) 13081384 PCA (8120) 13096518 PCA (8120) 13096520 PCA (8120) 13096532 PCA (8120) 13096538 PCA (8120) 13096800 PCA (8120) 13096812 PCA (8120) 13096814 PCA (8120) 13096944 PCA (8120) 13097130 PCA (8120) 13097157 PCA (8120) 13113383 PCA (8120) 13113468 PCA (8120) 13134042 PCA (8120) 13134073 PCA (8120) 13134172 PCA (8120) 13134186 PCA (8120) 13134230 PCA (8120) 13134323 PCA (8120) 14015426 PCA (8120) 14015566 PCA (8120) 14219103 PCA (8120) 14216794 PCA (8120) 14217593 PCA (8120) 14218526 PCA (8120) 14219469 PCA (8120) 13919809 PCA (8120) 13919202 PCA (8120) 13919567 PCA (8120) 13919591 PCA (8120) 13919328 PCA (8120) 13919810 PCA (8120) 13875008 PCA (8120) 13875021 PCA (8120) 13875207 PCA (8120) 13875293 PCA (8120) 13875611 PCA (8120) 13875635 PCA (8120) 13919066 PCA (8120) 13919219 PCA (8120) 13919239 PCA (8120) 13919278 PCA (8120) 13919281 PCA (8120) 13919365 PCA (8120) 13919431 PCA (8120) 13919444 PCA (8120) 13919462 PCA (8120) 13919467 PCA (8120) 13919556 PCA (8120) 13919574 PCA (8120) 13919589 PCA (8120) 13919613 PCA (8120) 13919614 PCA (8120) 13919615 PCA (8120) 13919626 PCA (8120) 13919641 PCA (8120) 13919721 PCA (8120) 13919723 PCA (8120) 13919769 PCA (8120) 13919776 PCA (8120) 13919777 PCA (8120) 13919778 PCA (8120) 13919811 PCA (8120) 13919833 PCA (8120) 13919834 PCA (8120) 13919927 PCA (8120) 13919928 PCA (8120) 13919780 PCA (8120) 13919448 PCA (8120) 13919378 PCA (8120) 13919445 PCA (8120) 13875499…
FDA’s list runs to 3,670,467 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.
US - AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY OUS - AE, AU, BE, BH, CA, CH, CN, IN, KW, MX, MY, NL, NZ, PH, QA, SA, TW and ZA
The states and territories these words name
54 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- American Samoa
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Guam
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Northern Mariana Islands
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Aug 4, 2020.
- FDA classified it on Sep 4, 2020.
- FDA’s Enforcement Report published it on Sep 16, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- CareFusion 303, Inc., of San Diego, 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 3,670,467 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.