FDA recall Z-1452-2025

Product

Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2) ARTHROSCOPY PACK-LF, Pack Number DYNJ0390808F; 3) ARTHROSCOPY PACK-LF, Pack Number DYNJ23150J; 4) ARTHROSCOPY PACK-LF, Pack Number DYNJ21233O; 5) ARTHROSCOPY PACK-LF, Pack Number DYNJ21233O; 6) ARTHROSCOPY TRAY, Pack Number DYNJ46435A; 7) KNEE ARTHROSCOPY PACK, Pack Number DYNJ50120D

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Key facts

Status

Ongoing

Initiation date

2025-02-11

Report date

2025-04-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1452-2025