Recalling firm
Medline Industries, LP
Product type
Device
Status
Ongoing
Report date
2026-07-01
Distribution
US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados.
Firm state
IL
Product quantity
113,843 kits
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change ControlReason for recall
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Product description
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. KIT NEURO CSTM SAMP0551
Code / lot info
SAMP0551 UDI-DI 10195327268503 Lots 22JBG593 22JBJ361
Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.