Medical Procedure Kits Correction: Medline Industries, LP Issues Correction for Medline Craniotomy Kits Containing Codman Disposable Perforators Due to Risk for Device Disassembly
This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Affected Product
- Product Names: Craniotomy Kits containing Codman Disposable Perforator 14mm
- Unique Device Identifier (UDI)/SKU/Lots: See full list of affected devices below.
What to Do
- Check stock for the affected kits.
- Quarantine all affected product.
On April 22, 2025, Medline Industries, LP sent all affected customers an Immediate Action Required Voluntary Medical Device Recall notice recommending the following actions:
- Immediately check all stock for the affected item number and affected lot numbers.
- Quarantine all affected product immediately.
- Complete the response form through the link included in the letter. Enter the recall reference number and code also provided in the letter.
- Complete the form even if there is no affected product in inventory.
- Customers will receive labels to place on the outside of affected kits after completing the response form.
- The labels instruct staff to remove the Codman Disposable Perforator 14 mm before using the kit.
- Notify any companies or others who may have received affected products.
- Distributors should include customers’ kit quantities on the distributor’s response form.
Reason for Correction
Medline Industries, LP is correcting certain lots of their Craniotomy Kits containing recalled Codman Disposable Perforators 14mm. Integra LifeSciences is recalling the perforators due to an inadequate weld that may cause the perforator to come apart before, during or after use in a craniotomy procedure.
The use of affected product may cause serious adverse health consequences, including tears in the membrane surrounding the brain (dura), bleeding, brain tissue bruising (contusions), irreversible brain damage, and death.
There have been no reported injuries. There have been no reports of death.
Device Use
Medline Craniotomy Kits are convenience kits used for various surgical procedures. The Codman Disposable Perforator 14 mm contained in these kits are single-use surgical tools used in neurosurgical procedures to drill access holes into the skull. They are designed to automatically disengage once drilling is complete.
Contact Information
Customers in the U.S. with questions about this recall should contact Medline’s Recall Department at 866-359-1704 or recalls@medline.com.
Full List of Affected Devices
| Device Description | SKU | UDI-DI | Lots |
|---|---|---|---|
| Craniotomy Kit | DYNJ35349C | 10888277858060 (EA), 40888277858061 (CASE) | 24CBJ925, 24DBT405, 24FBO318 |
| CRANI Accessory Pack | DYNJ59270 | 10888277771512 (EA), 40888277771513 (CASE) | 23JDB683, 23JDC548, 24ADB783, 24HDA822 |
| CRANI PACK-LF | DYNJ44805M | 10195327506872 (EA), 40195327506873 (CASE) | 23JBI747, 23KBL228, 24ABG696, 24CBM117, 24EBQ114, 24GBJ699 |
| CRANIOTOMY KIT | CDS982719V | 10195327510831 (EA), 40195327510832 (CASE) | 23KBP461, 23LBN381, 24ABB119, 24BBC547, 24BBI145 |
| CRANIOTOMY KIT | CDS982719W | 10195327645090 (EA), 40195327645091 (CASE) | 24DBS813 |
| CRANIOTOMY KIT | DYNJ904168F | 10195327395728 (EA), 40195327395729 (CASE) | 24DBU188 |
| CRANIOTOMY KIT | DYNJ908404B | 10195327410506 (EA), 40195327410507 (CASE) | 23IDB680, 23LDB546, 24BDB174, 24FDA741, 24FDB584, 24IDA225, 24IDA646, 24IDA840 |
| CRANIOTOMY KIT | DYNJ908723A | 10195327403270 (EA), 40195327403271 (CASE) | 23IBO314, 23JBC218, 24ABK090 |
| CRANIOTOMY KIT | DYNJ908723C | 10198459009785 (EA), 40198459009786 (CASE) | 24IBM205, 24IBN365, 25ABM356 |
| CRANIOTOMY #IMF 56646-LF | DYNJVB91001A | 10195327466466 (EA), 40195327466467 (CASE) | 23JLA765, 24DLA724, 24DLB006, 24ELA325 |
| CRANIOTOMY CDS | CDS981888X | 10195327144760 (EA), 40195327144761 (CASE) | 24ABT432, 24CBD698, 24HBH954, 24HBP483, 24IBG797, 25CBF098 |
| CRANIOTOMY CDS | CDS983467I | 10195327457945 (EA), 40195327457946 (CASE) | 23KDA336 |
| CRANIOTOMY PACK-LF | DYNJ09882G | 10195327574055 (EA), 40195327574056 (CASE) | 24CBF778 |
| CRANIOTOMY PACK-LF | DYNJ09882I | 10198459058172 (EA), 40198459058173 (CASE) | 24HBN426 |
| CRANIOTOMY S NASSAU | DYNJ905879G | 10195327512996 (EA), 40195327512997 (CASE) | 23KBI086, 23LBH647, 23LBH649, 24BBU253, 24DBV133, 24FBE409 |
| MHC CRANIOTOMY | DYNJ903713K | 10195327201579 (EA), 40195327201570 (CASE) | 23JBK426 |
| MHC CRANIOTOMY | DYNJ903713L | 10195327531218 (EA), 40195327531219 (CASE) | 23KBT939, 23LBS862, 24ABH577, 24CBH126, 24CBH771 |
| PAD CRANIOTOMY | DYNJ902149J | 10195327554323 (EA), 40195327554324 (CASE) | 23KBP275, 24ABJ684, 24CBF216, 24DBI296, 24EBD959, 24FBF064, 24HBK164, 24IBN443 |
| CRANI ADD A PACK | DYNJ30926O | 10195327539153 (EA), 40195327539154 (CASE) | 24AMF811 |
| CRANIOTOMY KIT | CDS983611N | 10195327466626 (EA), 40195327466627 (CASE) | 23KBA720, 23LBI611, 23LBJ586 |
| CRANIOTOMY CDS | CDS983467J | 10195327561116 (EA), 40195327561117 (CASE) | 24ADA818, 24ADC216, 24BDA929, 24DDB447, 24EDA275, 24EDA751, 24GDB213, 24IDA327, 24IDB043 |
| CRANIOTOMY PACK | DYNJ85807A | 10195327637392 (EA), 40195327637393 (CASE) | 24CBB843, 24EBC889, 24GBY029 |
| CRANIOTOMY PACK | DYNJ85927 | 10195327575571 (EA), 40195327575572 (CASE) | 24BMD310, 24EMI836 |
| MAJOR CRANIOTOMY PACK | DYNJ82007A | 10195327635466 (EA), 40195327635467 (CASE) | 24CMA496, 24HMI081, 24HMI978 |
Additional FDA Resources
- Cranial Drill Recall: Integra LifeSciences Recalls Codman Disposable Perforators Due to Risk of Device Disassembly [7/17/2025]
- FDA’s Enforcement Reports
- Medical Device Recall Database
Additional Company Resources
Company provided information on a recall, is posted here by the FDA as a public service.
- Medline Industries, LP Find a Recall (Recall number and code are required)
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.