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Medline Kits containing Codman Disposable Perforator 14 mm recallZ-1810-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Apr 22, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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 [email protected].

Recall details

Recall number
Z-1810-2025
Status
Open, Classified
Initiated by the company
Apr 22, 2025
Posted by the FDA
May 31, 2025
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
1853 total
Product code
OJG
FDA submissions
K213481
Distribution
US distribution to CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA and WI. No OUS distribution.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

321 devices cleared under K213481 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 96821).

Sources and updates

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