Honeywell Pressure Transducer
Medical device recall Z-1529-2020. Published in FDA’s Enforcement Report on Apr 1, 2020.
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 Apr 1, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 3561 units 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?
The firm is replacing pressure transducers with an improved design due to an increase in customer complaints regarding lower long-term reliability of the part.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Delivery System; 2008T HD SYS. BLUE STAR; 2008K2, Common Name: Hemodialysis Delivery Equipment; 2008K@home, Common Name: Hemodialysis Delivery System
3561 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial numbers 9T0S238668 9T0S238737 9T0S238795 9T0S238796 9T0S238798 9T0S239031 9T0S239133 9T0S239135 9T0S239143 9T0S239153 9T0S239173 9T0S239189 9T0S239198 9T0S239215 9T0S239229 9T0S239244 9T0S239245 9T0S239246 9T0S239250 9T0S239255…
Every code shown here, 1,995 characters
Serial numbers 9T0S238668 9T0S238737 9T0S238795 9T0S238796 9T0S238798 9T0S239031 9T0S239133 9T0S239135 9T0S239143 9T0S239153 9T0S239173 9T0S239189 9T0S239198 9T0S239215 9T0S239229 9T0S239244 9T0S239245 9T0S239246 9T0S239250 9T0S239255 9T0S239268 9T0S239280 9T0S239284 9T0S239353 9T0S239364 9T0S239366 9T0S239387 9T0S240371 9T0S239371 9T0S239424 9T0S239425 9T0S239443 9T0S239251 9T0S239329 9T0S239352 9T0S239358 9T0S239367 9T0S239388 9T0S239497 9T0S239499 9T0S243430 9T0S243570 9T0S243649 9T0S239369 9T0S239475 9T0S239743 9T0S239800 9T0S239844 9T0S239878 9T0S239902 9T0S239904 9T0S239910 9T0S239926 9T0S239927 9T0S239951 9T0S239953 9T0S239956 9T0S239960 9T0S239969 9T0S239970 9T0S239973 9T0S240017 9T0S240024 9T0S240029 9T0S240038 9T0S240039 9T0S240064 9T0S243832 9T0S243958 9T0S243961 9T0S244019 9T0S244025 9T0S244040 9T0S244041 9T0S244049 9T0S244063 9T0S240259 9T0S240268 9T0S238283 9T0S238182 9T0S238202 9T0S238211 9T0S238214 9T0S238223 9T0S238224 9T0S238225 9T0S238226 9T0S238227 9T0S238228 9T0S238229 9T0S238234 9T0S238239 9T0S238241 9T0S238243 9T0S238244 9T0S238247 9T0S238248 9T0S238249 9T0S238250 9T0S238252 9T0S238254 9T0S238256 9T0S238259 9T0S238263 9T0S238266 9T0S238270 9T0S238274 9T0S238284 9T0S238300 9T0S238304 9T0S238311 9T0S238313 9T0S238321 9T0S240408 9T0S240456 9T0S240486 9T0S240489 9T0S240496 9T0S240501 9T0S240503 9T0S240514 9T0S240535 9T0S240541 9T0S240552 9T0S240562 9T0S240564 9T0S240565 9T0S240585 9T0S240587 9T0S240593 9T0S240597 9T0S240612 9T0S240634 9T0S240637 9T0S240644 9T0S238665 9T0S239372 9T0S239736 9T0S239764 9T0S243631 9T0S243648 9T0S243712 9T0S243744 9T0S243746 9T0S243747 9T0S244002 9T0S244026 9T0S244053 9T0S244054 9T0S244064 9T0S244077 9T0S244079 9T0S244093 9T0S244113 9T0S244121 9T0S244126 9T0S244135 9T0S244136 9T0S244143 9T0S244148 9T0S244154 9T0S244169 9T0S243535 9T0S243623 9T0S243650 9T0S243667 9T0S243685 9T0S243696 9T0S243697 9T0S243698 9T0S243700 9T0S243715 9T0S243718 9T0S243727 9T0S243738 9T0S243740 9T0S243749 9T0S243751 9T0S243753 9T0S243756…
FDA’s list runs to 39,186 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 Nationwide distribution.
These words name no state.
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.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Jan 29, 2020.
- FDA classified it on Mar 20, 2020.
- FDA’s Enforcement Report published it on Apr 1, 2020.
- FDA terminated it on Jan 6, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Fresenius Medical Care Holdings, Inc., of Waltham, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Telephone.
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 39,186 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.