FDA recall Z-0635-2025

Product

Refer to RES or lead review memo for complete list of affected reference/catalog numbers

Reason for recall

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-10-09

Report date

2024-12-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0635-2025