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Use caution Medical device recall · FDA · Published April 22, 2025

Medline Recalls 14mm Perforators with Risk of Breaking in Surgical Kits

Medline recalls surgical kits containing Codman Disposable Perforators 14mm with inadequate welds that may break or separate during use.

🇺🇸 FDA recall #Z-1809-2025Medical deviceMedline ›
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Recalling firmMEDLINE INDUSTRIES, LP - Northfield3 Lakes Dr · Northfield, IL 60093-2753
✎ GovInfoNow plain-language explainer

What happened, in plain English

Medline is recalling surgical kits that include Codman Disposable Perforators 14mm due to inadequate welds. These perforators may break or separate, which could lead to complications during medical procedures. Read more at govinfonow.com/recall/52428-medline-recalls-14mm-perforators-with-risk-of-breaking-in-surgical.

Source Summary by GovInfoNow · govinfonow.com/recall/52428-medline-recalls-14mm-perforators-with-risk-of-breaking-in-surgical · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1809-2025

Cite this page

“Medline Recalls 14mm Perforators with Risk of Breaking in Surgical Kits.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52428-medline-recalls-14mm-perforators-with-risk-of-breaking-in-surgical. Based on FDA recall #Z-1809-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1809-2025%22&limit=1).

Why it’s dangerous

The perforators have inadequate welds on specific lots, meaning they may break or separate during use. This could cause injury or complications during surgical procedures if the perforator fails unexpectedly.

Who’s affected

Surgical professionals using Medline kits with specific SKUs and kit lots listed in the recall. Patients undergoing procedures with these kits are at risk of complications if the perforators break.

How to tell if you have this one

Check for the following SKUs and kit lots: CRANI ADD A PACK (SKU DYNJ30926O), CRANIOTOMY (SKU CDS983611N), CRANIOTOMY CDS (SKU CDS983467J), CRANIOTOMY PACK (SKUs DYNJ85807A and DYNJ85927), and MAJOR CRANIOTOMY PACK (SKU DYNJ82007A). The kit lots include specific combinations like 24AMF811, 23KBA720, 23LBI611, and others listed in the recall.

  • Brand
    Medline
  • Category
    Medical device
FDA recall event · 3 products

All 3 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 I
  • Status
    Ongoing
  • Distribution
    US distribution to CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA and WI. No OUS distribution.
Recall numberProduct, codes & lotsQuantity
Z-1809-2025Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS983611N 3. CRANIOTOMY CDS, SKU CDS983467J 4. CRANIOTOMY PACK, SKU DYNJ85807A, DYNJ85927 5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A; 1. CRANI ADD A PACK, SKU DYNJ30926O, UDI-DI 10195327539153 (EA), 40195327539154 (CASE) KIT LOTS 24AMF811 2. CRANIOTOMY, SKU CDS983611N, UDI-DI 10195327466626 (EA), 40195327466627 (CASE) KIT LOTS 23KBA720 23LBI611 23LBJ586 3. CRANIOTOMY CDS, SKU CDS983467J, UDI-DI 10195327561116 (EA), 40195327561117 (CASE) KIT LOTS 24ADA818 24ADC216 24BDA929 24DDB447 24EDA275 24EDA751 24GDB213 24IDA327 24IDB043 4. CRANIOTOMY PACK, SKU DYNJ85807A, UDI-DI 10195327637392 (EA), 40195327637393 (CASE) KIT LOTS 24CBB843 24EBC889 24GBY029 ; SKU DYNJ85927, UDI-DI 10195327575571 (EA), 40195327575572 (CASE) KIT LOTS 24BMD310 24EMI836 5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A UDI-DI 10195327635466 (EA), 40195327635467 (CASE) KIT LOTS 24CMA496 24HMI081 24HMI9781853 total
Z-1810-2025Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C; UDI-DI 10888277858060 (EA); 40888277858061 (CASE) KIT LOTS 24CBJ925 24DBT405 24FBO3181853 total
Z-1811-2025Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2. CRANI PACK-LF SKU DYNJ44805M 3. CRANIOTOMY SKU CDS982719V CDS982719W DYNJ904168F DYNJ908404B DYNJ908723A DYNJ908723C 4. CRANIOTOMY #IMF 56646-LF SKU DYNJVB91001A 5. CRANIOTOMY CDS SKU CDS981888X CDS983467I 6. CRANIOTOMY PACK-LF SKU DYNJ09882G DYNJ09882I 7. CRANIOTOMY S NASSAU SKU DYNJ905879G 8. MHC CRANIOTOMY SKU DYNJ903713K DYNJ903713L 9. PAD CRANIOTOMY SKU DYNJ902149J; 1. CRANI ACCESSORY PACK SKU DYNJ59270 UDI-DI 10888277771512 (ea), 40888277771513 (case) Lots 23JDB683 23JDC548 24ADB783 24HDA822 2. CRANI PACK-LF SKU DYNJ44805M UDI-DI 10195327506872 (ea), 40195327506873 (case) Lots 23JBI747 23KBL228 24ABG696 24CBM117 24EBQ114 24GBJ699 3. CRANIOTOMY SKU CDS982719V UDI-DI 10195327510831 (ea), 40195327510832 (case) Lots 23KBP461 23LBN381 24ABB119 24BBC547 24BBI145 SKU CDS982719W UDI-DI 10195327645090 (ea), 40195327645091 (case) Lots 24DBS813 SKU DYNJ904168F UDI-DI 10195327395728 (ea), 40195327395729 (case) Lots 24DBU188 SKU DYNJ908404B UDI-DI 10195327410506 (ea), 40195327410507 (case) Lots 23IDB680 23LDB546 24BDB174 24FDA741 24FDB584 24IDA225 24IDA646 24IDA840 SKU DYNJ908723A UDI-DI 10195327403270 (ea), 40195327403271 (case) Lots 23IBO314 23JBC218 24ABK090 SKU DYNJ908723C UDI-DI 10198459009785 (ea), 40198459009786 (case) Lots 24IBM205 24IBN365 25ABM356 4. CRANIOTOMY #IMF 56646-LF SKU DYNJVB91001A UDI-DI 10195327466466 (ea), 40195327466467 (case) Lots 23JLA765 24DLA724 24DLB006 24ELA325 5. CRANIOTOMY CDS SKU CDS981888X UDI-DI 10195327144760 (ea), 40195327144761 (case) Lots 24ABT432 24CBD698 24HBH954 24HBP483 24IBG797 25CBF098 SKU CDS983467I UDI-DI 10195327457945 (ea), 40195327457946 (case) Lots 23KDA336 6. CRANIOTOMY PACK-LF SKU DYNJ09882G UDI-DI 10195327574055 (ea), 40195327574056 (case) Lots 24CBF778 SKU DYNJ09882I UDI-DI 10198459058172 (ea), 40198459058173 (case) Lots 24HBN426 7. CRANIOTOMY S NASSAU SKU DYNJ905879G UDI-DI 10195327512996 (ea), 40195327512997 (case) Lots 23KBI086 23LBH647 23LBH649 24BBU253 24DBV133 24FBE409 8. MHC CRANIOTOMY SKU DYNJ903713K UDI-DI 10195327201579 (ea), 40195327201570 (case) Lots 23JBK426 SKU DYNJ903713L UDI-DI 10195327531218 (ea), 40195327531219 (case) Lots 23KBT939 23LBS862 24ABH577 24CBH126 24CBH771 9. PAD CRANIOTOMY SKU DYNJ902149J UDI-DI 10195327554323 (ea), 40195327554324 (case) Lots 23KBP275 24ABJ684 24CBF216 24DBI296 24EBD959 24FBF064 24HBK164 24IBN4431,853 total
Based on the official FDA remedy

What to do — step by step

  1. Check Kit Lot Numbers

    Look for kit lot numbers on the packaging, such as 24AMF811 or 23KBA720, to determine if your kit is affected.

  2. Contact Medline for Details

    Reach out to Medline directly using the contact information provided in the recall notice to confirm if your specific kit is affected.

Where it went and when

Where it was distributed

Distributed in 13 states.

Alaska: not listedAKMaine: not listedMEVermont: yesVTNew Hampshire: not listedNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: yesKYWest Virginia: not listedWVVirginia: not listedVAMaryland: yesMDDelaware: 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: yesFL

FDA distribution: “US distribution to CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA and WI. No OUS distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Florida, Illinois, Indiana, Kentucky, Maryland, Massachusetts, Minnesota, New York, Texas, Vermont, Washington, Wisconsin.

Recall timeline

FDA published this recall 50 days after the firm started it.

1. Firm started the recall: Apr 22, 202512. FDA classified it Class I: May 30, 202523. Published in FDA’s Enforcement Report: Jun 11, 202532025
  1. Firm started the recall
  2. FDA classified it Class I
  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-1809-2025 (April 22, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1809-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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