Hearth Record

Medline Convenience kits, labeled as: 1) NERVE STIMULATOR, Pack Number CDS981579O

Medical device recall Z-2635-2024. Published in FDA’s Enforcement Report on Sep 4, 2024.

FDA’s own record, on accessdata.fda.gov

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 4, 2024. Copied from openFDA on Oct 20, 2026.

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

Medline Convenience kits, labeled as: 1) NERVE STIMULATOR, Pack Number CDS981579O ; 2) DR DIULUS INJECTION PACK, Pack Number DYNDA2391; 3) BLOCK KIT , Pack Number DYNDA2508; 4) NERVE BLOCK PAIN PACK, Pack Number DYNDL1389; 5) BLOCK TRAY-LF , Pack Number DYNJ0117039; 6) NERVE BLOCK ACCESSORY PACK, Pack Number DYNJ0134147D ; 7) UNIVERSAL PROC TRAY-LF, Pack Number DYNJ02120B ; 8) ANGIO PROCEDURE PACK-LF , Pack Number DYNJ0298504AJ; 9) CUSTOM BLOCK KEMP PACK-LF , Pack Number DYNJ0371999G ; 10) PAIN MANAGEMENT PACK-LF , Pack Number DYNJ0374104F ; 11) THORASCOPIC - UNIV, Pack Number DYNJ0375880O ; 12) ANGIOGRAPHIC PACK II-LF , Pack Number DYNJ0543507AB; 13) GM ANGIOGRAPHY PACK-LF, Pack Number DYNJ0621584Y ; 14) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0689247S ; 15) PERI NEURO BLOCK PACK-LF, Pack Number DYNJ0703127A ; 16) MAJOR HEAD/NECK PACK-LF , Pack Number DYNJ0826705L ; 17) STANDARD BLOCK PACK-LF, Pack Number DYNJ0957047C ; 18) STANDARD BLOCK PACK-LF, Pack Number DYNJ0957047CH; 19) NECK PACK , Pack Number DYNJ17213C ; 20) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ20085K ; 21) ANGIO CATH PACK-MARY IMMACULAT, Pack Number DYNJ24517D ; 22) PAIN MANAGEMENT , Pack Number DYNJ26879A ; 23) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJ32412B ; 24) UNIVERSAL BLOCK TRAY, Pack Number DYNJ32680; 25) ANGIOGRAM TRAY, Pack Number DYNJ33638J ; 26) NERVE BLOCK PACK-LF , Pack Number DYNJ34351B ; 27) PATIENT PREP TRAY , Pack Number DYNJ34489C ; 28) UNIVERSAL MAJOR PACK-LF , Pack Number DYNJ35760B ; 29) BLOCK-LF, Pack Number DYNJ36152A ; 30) TRANSFORAMINAL PACK , Pack Number DYNJ36406B ; 31) UNIVERSAL BLOCK TRAY, Pack Number DYNJ36781; 32) RADIOFREQUENCY PACK , Pack Number DYNJ37338C ; 33) MAJOR NEURO VCH , Pack Number DYNJ39218D ; 34) NEPHROSTOMY PACK, Pack Number DYNJ41069A ; 35) CVOR ANGIOGRAPHY PACK-LF, Pack Number DYNJ42367B ; 36) BLOCK PACK, Pack Number DYNJ44205C ; 37) NECK PACK-LF, Pack Number DYNJ46059A ; 38) UNIVERSAL RVHS-LF , Pack Number DYNJ46874; 39) BLOCK KIT-LF, Pack Number DYNJ47338; 40) ANGIO KIT , Pack Number DYNJ48177A ; 41) UNIVERSAL CORE DR RUNNELS PACK, Pack Number DYNJ52230; 42) ANGIO PACK-LF , Pack Number DYNJ52898B ; 43) NEPHROLOGY PACK , Pack Number DYNJ59089; 44) MAJOR ANGIO , Pack Number DYNJ59301A ; 45) NIJHER PAIN PACK, Pack Number DYNJ62009C; 46) NIJHER PAIN PACK, Pack Number DYNJ62009C ; 47) O NEILL PAIN PACK , Pack Number DYNJ62011C ; 48) NEPHROLOGY PACK , Pack Number DYNJ62930; 49) NEPHROLOGY PACK , Pack Number DYNJ63200A ; 50) NEURO GOODIE PACK - DUNN, Pack Number DYNJ64570; 51) THROMBECTOMY PACK - NEUROS, Pack Number DYNJ64580; 52) RADIOFREQUENCY, Pack Number DYNJ68289; 53) EPIDURAL PACK, Pack Number DYNJ68840A; 54) EPIDURAL PACK , Pack Number DYNJ68840A ; 55) NEURO , Pack Number DYNJ901405K; 56) NEURO LUMBAR, Pack Number DYNJ904111G; 57) NERVE BLOCK TRAY-LF , Pack Number DYNJRA0022A; 58) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0031B; 59) UNIVERSAL BLOCK PAIN PK , Pack Number DYNJRA0041 ; 60) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA0044 ; 61) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA0044A; 62) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA0044B; 63) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA0050A; 64) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0051B; 65) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0052 ; 66) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0087B; 67) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0104B; 68) UNIVERSAL BLOCK SPINAL-LF , Pack Number DYNJRA0105B; 69) UNIVERSAL BLOCK TRAY-LF, Pack Number DYNJRA0110A; 70) UNIVERSAL BLOCK TRAY-LF, Pack Number DYNJRA0111; 71) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0139D; 72) PAIN CLINIC , Pack Number DYNJRA0173B; 73) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0179 ; 74) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0186C; 75) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0187B; 76) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0191C; 77) NERVE BLOCK TRAY (FACET)-LF , Pack Number DYNJRA0207A; 78) NERVE

1,679,067 units in total, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

CDS981579O , Lot Number 21JBM647 ; CDS981579O , Lot Number 21JBQ860 ; CDS981579O , Lot Number 22CBX741 ; CDS981579O , Lot Number 19EBL586 ; CDS981579O , Lot Number 19GBJ538 ; CDS981579O , Lot Number 19IBH976 ; CDS981579O , Lot Number…

Every code shown here, 1,993 characters

CDS981579O , Lot Number 21JBM647 ; CDS981579O , Lot Number 21JBQ860 ; CDS981579O , Lot Number 22CBX741 ; CDS981579O , Lot Number 19EBL586 ; CDS981579O , Lot Number 19GBJ538 ; CDS981579O , Lot Number 19IBH976 ; CDS981579O , Lot Number 19JBZ536 ; CDS981579O , Lot Number 19KBB918 ; CDS981579O , Lot Number 20ABP061 ; CDS981579O , Lot Number 20BBA647 ; CDS981579O , Lot Number 20DBM006 ; CDS981579O , Lot Number 20FBS525 ; CDS981579O , Lot Number 21ABO831 ; CDS981579O , Lot Number 21BBI363 ; CDS981579O , Lot Number 21CBI409 ; CDS981579O , Lot Number 21DBG604 ; CDS981579O , Lot Number 21FBC673 ; DYNDA2391, Lot Number 21JBR496 ; DYNDA2508, Lot Number 19FBY839 ; DYNDL1389, Lot Number 22FMG166; DYNDL1389, Lot Number 22DMC258; DYNDL1389, Lot Number 22NBA716; DYNJ0117039, Lot Number 19ALA192 ; DYNJ0117039, Lot Number 19FLA299 ; DYNJ0117039, Lot Number 19LLA121 ; DYNJ0117039, Lot Number 20ALA869 ; DYNJ0117039, Lot Number 20CLA195 ; DYNJ0117039, Lot Number 20GLA412 ; DYNJ0117039, Lot Number 20ILA113 ; DYNJ0117039, Lot Number 20JLA806 ; DYNJ0117039, Lot Number 20KLA286 ; DYNJ0117039, Lot Number 21ALA145 ; DYNJ0134147D , Lot Number 21JBP263 ; DYNJ0134147D , Lot Number 22ABI678 ; DYNJ0134147D , Lot Number 22EMB713 ; DYNJ0134147D , Lot Number 23CMA573 ; DYNJ0134147D , Lot Number 23GMB375 ; DYNJ0134147D , Lot Number 19AKA640 ; DYNJ0134147D , Lot Number 19BKA636 ; DYNJ0134147D , Lot Number 19CKD047 ; DYNJ0134147D , Lot Number 19EKC644 ; DYNJ0134147D , Lot Number 19GKC561 ; DYNJ0134147D , Lot Number 19IKB159 ; DYNJ0134147D , Lot Number 19JKC253 ; DYNJ0134147D , Lot Number 20AKA947 ; DYNJ0134147D , Lot Number 20BKB449 ; DYNJ0134147D , Lot Number 20EKA818 ; DYNJ0134147D , Lot Number 20GKA349 ; DYNJ0134147D , Lot Number 21AKA686 ; DYNJ02120B , Lot Number 19ELA164 ; DYNJ0298504AJ, Lot Number 20LLA110 ; DYNJ0298504AJ, Lot Number 20LLA676 ; DYNJ0298504AJ, Lot Number 21ALA366 ; DYNJ0298504AJ, Lot Number 21BLA389 ; DYNJ0298504AJ, Lot Number 21DLA191 ; DYNJ0298504AJ, Lot Number 21ELA067 ;…

FDA’s list runs to 334,508 characters. The first part is shown; the rest is on FDA’s record.

Source:

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 distribution.

These words name no state.

The words say it went outside the United States too.

Source:

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Apr 8, 2024.
  • FDA classified it on Aug 28, 2024.
  • FDA’s Enforcement Report published it on Sep 4, 2024.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

  • MEDLINE INDUSTRIES, LP - Northfield, of Northfield, IL.
  • Who began it, in FDA’s words: Voluntary: Firm initiated.
  • How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
Source:

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 334,508 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.
Source:

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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

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Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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