MEDLINE INDUSTRIES, LP - Northfield recalls Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B; 2) UROLOGY ROBOTIC, REF DYNJ55555D; 3) KIT,SPINE LH, REF DYNJ906448A.

Medline issued a MEDICAL DEVICE VOLUNTARY RECALL notice on 11/21/2024 to its consignees via US Mail and email. The notice explained the issue, potential risk to health, and requested that the affected product be quarantined. Once the response is received, Medline will provide labels to place on affected inventory, with instructions for the consignee to remove the affected component prior to using the kit.

• FDA enforcement recordOfficial FDA database entry for Z-0792-2025
• FDA device classification · OHDOfficial FDA classification for this device type
• CFR regulation · 21 CFR 884.1720The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find MEDLINE INDUSTRIES, LP - NorthfieldSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.