Blood Pressure Module BPM3 TM-2917B (Spare
Medical device recall Z-3124-2024. Published in FDA’s Enforcement Report on Sep 18, 2024.
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 18, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 3,718 systems 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?
Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the cuff.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
3,718 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 190573 NA 190713 00840861100897 (+ Serial Number) 190766 00840861100910 (+ Serial Number) 190858 00840861100903 (+ Serial Number) 190895 00840861100927 (+ Serial Number) 190908 00840861100934 (+ Serial Number) 191124 00840861102082…
Every code shown here, 2,000 characters
UDI-DI: 190573 NA 190713 00840861100897 (+ Serial Number) 190766 00840861100910 (+ Serial Number) 190858 00840861100903 (+ Serial Number) 190895 00840861100927 (+ Serial Number) 190908 00840861100934 (+ Serial Number) 191124 00840861102082 (+ Serial Number) 191126 00840861102099 (+ Serial Number) 191128 00840861102105 (+ Serial Number) 191130 00840861102112 (+ Serial Number) Serial Numbers: 4T0S278166 4T0S278222 4T0S278232 4T0S278242 4T0S278353 4T0S278386 4T0S278395 4T0S278427 4T0S278445 4T0S278466 4T0S278471 4T0S278474 4T0S278477 4T0S278810 4T0S278824 4T0S278832 4T0S278835 4T0S278840 4T0S278841 4T0S278842 4T0S278845 4T0S278846 4T0S278847 4T0S278848 4T0S278851 4T0S278852 4T0S278859 4T0S278860 4T0S278862 4T0S275623 4T0S275627 4T0S275628 4T0S275629 4T0S275639 4T0S275649 4T0S275654 4T0S275662 4T0S275664 4T0S275666 4T0S275677 4T0S275682 4T0S275685 4T0S275688 4T0S275692 4T0S275703 4T0S275729 4T0S275738 4T0S275742 4T0S275745 4T0S275760 4T0S275768 4T0S275769 4T0S275778 4T0S275787 4T0S275800 4T0S275804 4T0S276804 4T0S276814 4T0S276818 4T0S276829 4T0S276833 4T0S276838 4T0S276858 4T0S276867 4T0S276870 4T0S276807 4T0S276886 4T0S276894 4T0S276895 4T0S276897 4T0S276909 4T0S276911 4T0S276912 4T0S276916 4T0S276921 4T0S276926 4T0S276928 4T0S276934 4T0S276952 4T0S276960 4T0S276961 4T0S276963 4T0S276964 4T0S276965 4T0S276969 4T0S276973 4T0S276976 4T0S276979 4T0S276991 4T0S276998 4T0S276999 4T0S277004 4T0S277005 4T0S278031 4T0S278068 4T0S278087 4T0S278088 4T0S278105 4T0S278107 4T0S278109 4T0S278122 4T0S278124 4T0S278144 4T0S278149 4T0S278154 4T0S278157 4T0S278159 4T0S278183 4T0S278190 4T0S278193 4T0S278196 4T0S278198 4T0S278199 4T0S278206 4T0S278207 4T0S278217 4T0S278218 4T0S277002 4T0S277003 4T0S277025 4T0S277048 4T0S277054 4T0S277077 4T0S277090 4T0S277094 4T0S277095 4T0S277099 4T0S277115 4T0S277345 4T0S277355 4T0S277367 4T0S277371 4T0S277374 4T0S277380 4T0S277381 4T0S277392 4T0S277398 4T0S277419 4T0S277420 4T0S277424 4T0S277431 4T0S277434 4T0S277452 4T0S277459 4T0S277475 4T0S277762…
FDA’s list runs to 41,292 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. Canada.
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?
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 8, 2024.
- FDA classified it on Sep 11, 2024.
- FDA’s Enforcement Report published it on Sep 18, 2024.
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: 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 41,292 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.