FDA recall Z-1810-2025

Product

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

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2025-04-22

Report date

2025-06-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1810-2025