—#213726

Product

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

FDA product code: OJG — Neurological Tray
Device class: Class 1
Medical specialty: Neurology
510(k) numbers: K213481
Affected lot / code info: UDI-DI 10888277858060 (EA); 40888277858061 (CASE) KIT LOTS 24CBJ925 24DBT405 24FBO318

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

On April 22, 2025, the firm notified customers of the recall through letters titled Immediate Action Required Voluntary Medical Device Recall. Customers were instructed to identify and quarantine all affected product on hand. Customers are to submit a response form to the recalling firm. Upon receipt of the response firm, Medline will provide the customer with over-labels to place on affected inventory, which will include instructions for staff to remove and discard the affected component prior to using the kit. Distributors should notify downstream customers/accounts of this recall. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

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

Timeline

Recall initiated: 2025-04-22
Posted by FDA: 2025-05-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213726. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.