Z-1809-2025Class I

Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2...

Name: Z-1809-2025 Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2025-04-22
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-04-22 / Open, Classified / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS983611N 3. CRANIOTOMY CDS, SKU CDS983467J... on 2025-04-22. FDA classified it as Class I and gives the reason as "Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1809-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-04-22
Posted: 2025-05-31
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS983611N 3. CRANIOTOMY CDS, SKU CDS983467J 4. CRANIOTOMY PACK, SKU DYNJ85807A, DYNJ85927 5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A
Product code: LRO General Surgery Tray
Reason for recall: 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 tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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].
Quantity in commerce: 1853 total
Distribution: US distribution to CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA and WI. No OUS distribution.
Product codes and lots: 1. CRANI ADD A PACK, SKU DYNJ30926O, UDI-DI 10195327539153 (EA), 40195327539154 (CASE) KIT LOTS 24AMF811 2. CRANIOTOMY, SKU CDS983611N, UDI-DI 10195327466626 (EA), 40195327466627 (CASE) KIT LOTS 23KBA720 23LBI611 23LBJ586 3. CRANIOTOMY CDS, SKU CDS983467J, UDI-DI 10195327561116 (EA), 40195327561117 (CASE) KIT LOTS 24ADA818 24ADC216 24BDA929 24DDB447 24EDA275 24EDA751 24GDB213 24IDA327 24IDB043 4. CRANIOTOMY PACK, SKU DYNJ85807A, UDI-DI 10195327637392 (EA), 40195327637393 (CASE) KIT LOTS 24CBB843 24EBC889 24GBY029 ; SKU DYNJ85927, UDI-DI 10195327575571 (EA), 40195327575572 (CASE) KIT LOTS 24BMD310 24EMI836 5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A UDI-DI 10195327635466 (EA), 40195327635467 (CASE) KIT LOTS 24CMA496 24HMI081 24HMI978

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1809-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1809-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-06-11	2025-05-30
Z-1810-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-06-11	2025-05-30
Z-1811-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-06-11	2025-05-30

Product code LRO

K213481Class IIMedline General Surgery TrayMedline Industries, Inc. / cleared 2022-05-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)