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Lower risk Medical device recall · FDA · Published June 18, 2024

Medline CRANIOTOMY PACK Recall: Risk of Patient Infection Due to Non-Sterile Component

Medline recalls certain CRANIOTOMY PACKs with non-sterile Mastisol components that could cause patient infections if used without proper sterility checks.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3069-2024Medical deviceMedline Industries ›
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Contact the company

Recalling firmMEDLINE INDUSTRIES, LP - Northfield3 Lakes Dr · Northfield, IL 60093-2753
✎ GovInfoNow plain-language explainer

Medline is recalling specific CRANIOTOMY PACKs that contain a non-sterile Mastisol component. This poses a risk of patient infection if the user mistakenly assumes the product is sterile during use. Read more at govinfonow.com/recall/54792-medline-craniotomy-pack-recall-risk-of-patient-infection-due-to.

Source Summary by GovInfoNow · govinfonow.com/recall/54792-medline-craniotomy-pack-recall-risk-of-patient-infection-due-to · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3069-2024

Cite this page

“Medline CRANIOTOMY PACK Recall: Risk of Patient Infection Due to Non-Sterile Component.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54792-medline-craniotomy-pack-recall-risk-of-patient-infection-due-to. Based on FDA recall #Z-3069-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3069-2024%22&limit=1).

The FDA announced on June 18, 2024, that Medline Industries LP is recalling the CRANIOTOMY PACK (Pack Number DYNJ46552O) due to a non-sterile Mastisol component. This defect increases the risk of patient infection if users assume sterility during use.

How to tell if you have it

  • Brand: Medline Industries
  • Product: CRANIOTOMY PACK, Pack Number DYNJ46552O
  • Lot Numbers: 24ADB788, 23LDA936, 23JDB278, 23HDA872
  • Units affected: 188

The hazard

A non-sterile Mastisol component was placed in the non-sterile portion of certain sterile convenience kits and distributed. The component was not labeled as being sterile or non-sterile, creating an increased risk of patient infection if the user assumes sterility during its use.

Context

GovInfoNow's records show Medline Industries LP - Northfield has issued 119 other recalls since October 22, 2021. Recent brand recalls include Medline medical kits with light failure in newborn resuscitation kits (July 25, 2025) and Foley Tray Kits with incorrect labeling risk (July 23, 2025). Other recent recalls of similar products include Medline Convenience Kits Recall: Risk of Sterile Packaging Breach (June 12, 2026), Medline Eye Kits Recall: Risk of Sterile Packaging Breach (June 12, 2026), and Medline Convenience Kits Recall: Risk of Contaminated Sterile Products (January 7, 2026).

How to tell if you have this one

Check for pack number DYNJ46552O, lot numbers 24ADB788, 23LDA936, 23JDB278, or 23HDA872. The product is sold under the brand Medline Industries.

  • Brand
    Medline Industries
  • Category
    Medical device
FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US: TX, IL, CA
Recall numberProduct, codes & lotsQuantity
Z-3069-2024CRANIOTOMY PACK, Pack Number DYNJ46552O; UDI/DI Case 40195327467044, UDI/DI Each 10195327467043; Lot Numbers: 24ADB788, 23LDA936, 23JDB278, 23HDA872188 units
Z-3070-2024KIT PEDI CRANI LAMI, Pack Number DYNJ907372A; UDI/DI Case 40195327060412, UDI/DI Each 10195327060411; Lot Numbers: 23ILA372, 23ILA184, 23HLB240, 23HLA567, 23HLA126, 23ELA634, 23DLA974, 23ALA995, 22JLA577, 22HLA985, 22HLA379, 22GLB224, 22GLB099, 22GLA383, 22GLA171, 22DLA615, 22CLA957, 22ALA965, 22ALA325485 units
Z-3071-2024ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377; UDI/DI Case 40195327231126, UDI/DI Each 10195327231125; Lot Numbers: 22LBM357105 units
Z-3072-2024ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A; UDI/DI Case 40195327334209, UDI/DI Each 10195327334208; Lot Numbers: 23IBJ309, 23GBA500, 23GBA457, 23CBE394, 23BBL312315 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the pack number and lot numbers listed in the recall notice to confirm if your CRANIOTOMY PACK is affected.

Where it went and when

Where it was distributed

Distributed in 3 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: not listedFL

FDA distribution: “US: TX, IL, CA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Illinois, Texas.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: Jun 18, 202412. FDA classified it Class II: Sep 6, 202423. Published in FDA’s Enforcement Report: Sep 18, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-3069-2024 (June 18, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3069-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA