FDA recall Z-0465-2025

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)

Reason for recall

Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.

Distribution

US Nationwide distributions in the states of AL, AR, CO, CT, FL, IA, IN, KS, LA, MA, MO, NC, NY, OK, OR, RI, TN, TX, VA, WA, WY.

Key facts

Status
Ongoing
Initiation date
2024-10-21
Report date
2024-11-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0465-2025