Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF
Medical device recall Z-0724-2025. 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 for where it went
- 12,889 kits 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?
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T; 2) NEURO KIT, SKU CDS981327Q; 3) NEURO POSTERIOR SPINE PACK-LF, SKU DYNJ0311501I; 4) ACOUSTIC NEUROMA PACK-LF, SKU DYNJ37741D; 5) SCRIPPS SW NEURO PACK-LF, SKU DYNJ39836C; 6) SCRIPPS SW NEURO PACK-LF, SKU DYNJ39836D; 7) NEURO BUNDLE-LF, SKU DYNJ40095A; 8) NEURO BUNDLE-LF, SKU DYNJ40095B; 9) NEURO BUNDLE-LF, SKU DYNJ40095C; 10) NEURO BUNDLE-LF, SKU DYNJ40095D; 11) NEURO PACK-LF, SKU DYNJ42844D; 12) WMC VP SHUNT PACK-LF, SKU DYNJ50629J; 13) NEURO PACK, SKU DYNJ54255A; 14) NEURO CHRISTUS, SKU DYNJ61190A; 15) NEURO KIT, SKU DYNJ62854B; 16) NEURO KIT, SKU DYNJ62854C; 17) NEURO PACK NTX, SKU DYNJ66213D; 18) NEURO PACK, SKU DYNJ67628C; 19) BASIC NEURO CUSTOM, SKU DYNJ83387; 20) BASIC NEURO CUSTOM, SKU DYNJ83387A; 21) HALY NEURO PACK, SKU DYNJ87308; 22) FHWC NEURO, SKU DYNJ906131B; 23) CRANI, SKU DYNJ907865; 24) KIT NEURO LAFAYETTE, SKU DYNJ908615C; 25) GENERAL NEURO, SKU DYNJ909744
12,889 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: CDS780119T, 10888277762688 (each), 40888277762689 (case), Lot Numbers: 20EBU829; UDI-DI: CDS981327Q, 10195327080365 (each), 40195327080366 (case), Lot Numbers: 22FMH830 22FMF883; UDI-DI: DYNJ0311501I, 10889942265886 (each),…
Every code shown here, 1,987 characters
UDI-DI: CDS780119T, 10888277762688 (each), 40888277762689 (case), Lot Numbers: 20EBU829; UDI-DI: CDS981327Q, 10195327080365 (each), 40195327080366 (case), Lot Numbers: 22FMH830 22FMF883; UDI-DI: DYNJ0311501I, 10889942265886 (each), 40889942265887 (case), Lot Numbers: 22DMF117; UDI-DI: DYNJ37741D, 10195327548940 (each), 40195327548941 (case), Lot Numbers: 24EMD032; UDI-DI: DYNJ39836C, 10193489510324 (each), 40193489510325 (case), Lot Numbers: 20JMB588 20GMD367 20EMB420 20CMC383 20CMA256; UDI-DI: DYNJ39836D, 10193489477177 (each), 40193489477178 (case), Lot Numbers: 22EMA431 22CMC948 22BMD597 22AMG597 21JMF846 21IMA074 21GMF465 21GMC844 21CME103 21CMD623 21BMC249; UDI-DI: DYNJ40095A, 10193489370690 (each), 40193489370691 (case), Lot Numbers: 21KME983 21JMB244 21JMB245 21HMA330 21EME688 21DME512 21CMA323 20LMD710 20HMB030; UDI-DI: DYNJ40095B, 10195327068325 (each), 40195327068326 (case), Lot Numbers: 22GMB406 22EMA845 22CME763; UDI-DI: DYNJ40095C, 10195327211028 (each), 40195327211029 (case), Lot Numbers: 22JMH236; UDI-DI: DYNJ40095D, 10195327281250 (each), 40195327281251 (case), Lot Numbers: 24HMC151 24GMA340 24DMK362 24CMH592 24BMF793 24AMF590 24AMD886 23LMB475 23KMD199 23IMF930 23HMG523 23HMB850 23GMI744 23GMH136 23FMD605 23EMC157 23CME914 23BMC902 22LME175; UDI-DI: DYNJ42844D, 10193489880564 (each), 40193489880565 (case), Lot Numbers: 22HBZ336; UDI-DI: DYNJ50629J, 10195327081324 (each), 40195327081325 (case), Lot Numbers: 22FBF021; UDI-DI: DYNJ54255A, 10889942765256 (each), 40889942765257 (case), Lot Numbers: 20LBO578 20HBM398 20FBW118 20EBG032 20DBF296; UDI-DI: DYNJ61190A, 10193489453355 (each), 40193489453356 (case), Lot Numbers: 23HBX568 23GBU378 23EBU255 23EBB228 23CBK006 23BBF587 22LBP590 22LBO797 22KBH699 22JBI769 22IBF404 22HMF895 22EMH841 22DMI740 22CMH488 22CME013 21JME676 21IMG224 21IMB620 21GMC966 21EMB917 21BMD698 21BMD492 21BMB573; UDI-DI: DYNJ62854B, 10193489324402 (each), 40193489324403 (case), Lot Numbers: 20HBA904; UDI-DI: DYNJ62854C,…
FDA’s list runs to 3,152 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 Nov 6, 2024.
- FDA classified it on Dec 20, 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?
- MEDLINE INDUSTRIES, LP - Northfield, of Northfield, IL.
- 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 3,152 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
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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.