Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY
Medical device recall Z-0723-2025. 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.
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) CRANIOTOMY, SKU CDS982719X; 2) MVFF/FIBU #54-RF, SKU DYNJ21927Q; 3) MVFF/FIBU #54-RF, SKU DYNJ21927S; 3) NEURO PEDIATRIC, SKU DYNJ61607A; 4) CRANIOTOMY PACK, SKU DYNJ66419C; 5) LYMPHATIC BYPASS PACK, SKU DYNJ69907; 6) LYMPHATIC BYPASS PACK, SKU DYNJ69907A; 7) HEAD AND NECK PACK - 51597, SKU DYNJ81934B; 8) MAJOR CRANIOTOMY PACK, SKU DYNJ82007A; 9) SPINE PACK, SKU DYNJ82011A; 10) CRANIOTOMY MERCY STK 256, SKU DYNJ84068; 11) WMC UNIVERSAL NEURO PACK, SKU DYNJ84496A; 12) SPINE PACK LF, SKU DYNJ85830; 13) AHT SPINE PACK, SKU DYNJ903566D; 14) LAMINECTOMY SPINAL FUSION PACK, SKU DYNJ909364A; 15) DIEP, SKU DYNJ909472; 16) AMBULATORY SINUS, SKU DYNJ910292; 17) AMBULATORY SINUS, SKU DYNJ910292A
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: CDS982719X, 10198459064531 (each), 40198459064532 (case), Lot Numbers: 24IBE288; UDI-DI: DYNJ21927Q, 10889942885534 (each), 40889942885535 (case), Lot Numbers: 21LBB957 21KBA966 21IBN569 21GBO771 20KBB297 20JBB045 20IBI973 20HBU423…
Every code shown here, 1,960 characters
UDI-DI: CDS982719X, 10198459064531 (each), 40198459064532 (case), Lot Numbers: 24IBE288; UDI-DI: DYNJ21927Q, 10889942885534 (each), 40889942885535 (case), Lot Numbers: 21LBB957 21KBA966 21IBN569 21GBO771 20KBB297 20JBB045 20IBI973 20HBU423 20HBC730 20EBU633; UDI-DI: DYNJ21927S, 10195327576233 (each), 40195327576234 (case), Lot Numbers: 24GBQ357 24GBK331 24FBF951 24CBV435 24BBN342 24ABW268; UDI-DI: DYNJ61607A, 10193489665734 (each), 40193489665735 (case), Lot Numbers: 22FLB055 22FLA458; UDI-DI: DYNJ66419C, 10198459059353 (each), 40198459059354 (case), Lot Numbers: 24IBG439; UDI-DI: DYNJ69907, 10193489995558 (each), 40193489995559 (case), Lot Numbers: 22EMA026; UDI-DI: DYNJ69907A, 10195327163976 (each), 40195327163977 (case), Lot Numbers: 22FMB386; UDI-DI: DYNJ81934B, 10198459122910 (each), 40198459122911 (case), Lot Numbers: 24IBG522; UDI-DI: DYNJ82007A, 10195327635466 (each), 40195327635467 (case), Lot Numbers: 24IME319 24HMI978 24HMI081 24CMA496; UDI-DI: DYNJ82011A, 10195327635480 (each), 40195327635481 (case), Lot Numbers: 24HMI979 24GMJ808 24GMB190 24FMD601 24EMD223 24BMJ118; UDI-DI: DYNJ84068, 10195327332143 (each), 40195327332144 (case), Lot Numbers: 23HLA314; UDI-DI: DYNJ84496A, 10198459011245 (each), 40198459011246 (case), Lot Numbers: 24HBF172 24FBN697; UDI-DI: DYNJ85830, 10195327556471 (each), 40195327556472 (case), Lot Numbers: 24IBG585 24DBO636 24BBK513; UDI-DI: DYNJ903566D, 10195327560829 (each), 40195327560820 (case), Lot Numbers: 24BBO346 24BBK920 24ABO451 24ABO420; UDI-DI: DYNJ909364A, 10195327660420 (each), 40195327660421 (case), Lot Numbers: 24IMD666 24IMB155 24GMA069 24EMH357; UDI-DI: DYNJ909472, 10195327368821 (each), 40195327368822 (case), Lot Numbers: 24IMD560 24GMI069 23LMG055 23KMD713 23GME971 23GMA619; UDI-DI: DYNJ910292, 10195327618681 (each), 40195327618682 (case), Lot Numbers: 24HBI255 24HBF816 24GBR460 24FBL017; UDI-DI: DYNJ910292A, 10198459111723 (each), 40198459111724 (case), Lot Numbers: 24IBK954
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.”
- 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.