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Recall Observatory FDA recall evidence

Device product

Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C

Z-1810-2025

April 22, 2025

Class I

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 96821
Status
Ongoing
Classification
Class I
Quantity
1853 total
Official record key
device-enforcement:Z-1810-2025

Official wording

Reason: Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.

Code information: UDI-DI 10888277858060 (EA); 40888277858061 (CASE) KIT LOTS 24CBJ925 24DBT405 24FBO318

Distribution pattern: US distribution to CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA and WI. No OUS distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.