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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Medline Craniotomy Kits Recalled for Defective Codman Perforators

Agency Publication Date: May 31, 2025
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Summary

Medline Industries, LP has recalled 5,559 craniotomy kits that contain a specific surgical tool known as the Integra Lifesciences Codman Disposable Perforator (14 mm). These surgical kits, used during brain procedures, contain perforators with inadequate welds that may break or separate during use. No injuries have been reported at this time, but the manufacturer has initiated a voluntary recall of affected lots distributed across 13 states.

Risk

A perforator with a weak weld can break or come apart during surgery. This can lead to surgical delays, unintended injury to the brain, or pieces of the device being left inside the patient.

What You Should Do

  1. This recall affects various Medline surgical kits containing the Codman Disposable Perforator (14 mm), including kits sold under the names Craniotomy, Crani Accessory Pack, Crani Pack-LF, and Major Craniotomy Pack.
  2. Identify if your kit is affected by checking the SKU and Lot number printed on the packaging. Because this recall affects a high volume of products, see the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled surgical kits immediately.
  4. Contact Medline Industries, LP or your medical distributor to arrange for the return, replacement, or correction of the affected kits.
  5. Call the FDA at 1-888-INFO-FDA (1-888-463-6332) if you have further questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action

Hospital/Clinical Device Correction

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Medline Craniotomy Kits containing Codman Disposable Perforator 14 mm
Variants: CRANI ADD A PACK, CRANIOTOMY, CRANIOTOMY CDS, CRANIOTOMY PACK, MAJOR CRANIOTOMY PACK
Model / REF:
DYNJ30926O
CDS983611N
CDS983467J
DYNJ85807A
DYNJ85927
DYNJ82007A
Lot Numbers:
24AMF811
23KBA720
23LBI611
23LBJ586
24ADA818
24ADC216
24BDA929
24DDB447
24EDA275
24EDA751
24GDB213
24IDA327
24IDB043
24CBB843
24EBC889
24GBY029
24BMD310
24EMI836
24CMA496
24HMI081
24HMI978
UDI:
10195327539153
40195327539154
10195327466626
40195327466627
10195327561116
40195327561117
10195327637392
40195327637393
10195327575571
40195327575572
10195327635466
40195327635467

Recall #: Z-1809-2025

Product: Medline Craniotomy Kits containing Codman Disposable Perforator 14 mm
Variants: CRANIOTOMY
Model / REF:
DYNJ35349C
Lot Numbers:
24CBJ925
24DBT405
24FBO318
UDI:
10888277858060
40888277858061

Recall #: Z-1810-2025

Product: Medline Craniotomy Kits containing Codman Disposable Perforator 14 mm
Variants: CRANI ACCESSORY PACK, CRANI PACK-LF, CRANIOTOMY, CRANIOTOMY #IMF 56646-LF, CRANIOTOMY CDS, CRANIOTOMY PACK-LF, CRANIOTOMY S NASSAU, MHC CRANIOTOMY, PAD CRANIOTOMY
Model / REF:
DYNJ59270
DYNJ44805M
CDS982719V
CDS982719W
DYNJ904168F
DYNJ908404B
DYNJ908723A
DYNJ908723C
DYNJVB91001A
CDS981888X
CDS983467I
DYNJ09882G
DYNJ09882I
DYNJ905879G
DYNJ903713K
DYNJ903713L
DYNJ902149J
Lot Numbers (64):
23JDB683
23JDC548
24ADB783
24HDA822
23JBI747
23KBL228
24ABG696
24CBM117
24EBQ114
24GBJ699
23KBP461
23LBN381
24ABB119
24BBC547
24BBI145
24DBS813
24DBU188
23IDB680
23LDB546
24BDB174
24FDA741
24FDB584
24IDA225
24IDA646
24IDA840
23IBO314
23JBC218
24ABK090
24IBM205
24IBN365
25ABM356
23JLA765
24DLA724
24DLB006
24ELA325
24ABT432
24CBD698
24HBH954
24HBP483
24IBG797
25CBF098
23KDA336
24CBF778
24HBN426
23KBI086
23LBH647
23LBH649
24BBU253
24DBV133
24FBE409
UDI:
10888277771512
40888277771513
10195327506872
40195327506873
10195327510831
40195327510832
10195327645090
40195327645091
10195327395728
40195327395729
10195327410506
40195327410507
10195327403270
40195327403271
10198459009785
40198459009786
10195327466466
40195327466467
10195327144760
40195327144761
10195327457945
40195327457946
10195327574055
40195327574056
10198459058172
40198459058173
10195327512996
40195327512997
10195327201579
40195327201570
10195327531218
40195327531219
10195327554323
40195327554324

Recall #: Z-1811-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96821
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: hospitals; medical distributors
Manufactured In: United States
Units Affected: 3 products (1853 total; 1853 total; 1,853 total)
Distributed To: California, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, New York, Texas, Vermont, Washington, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.