FDA Medical devices recall ·
Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1810-2025
- Date
- (initiated April 22, 2025)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 1853 total
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI 10888277858060 (EA); 40888277858061 (CASE) KIT LOTS 24CBJ925 24DBT405 24FBO318
Distribution
US distribution to CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA and WI. No OUS distribution.
States: California Florida Illinois Indiana Kentucky Massachusetts Maryland Minnesota New York Texas Vermont Washington Wisconsin
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1810-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.