Recall Z-2985-2026— Bard Access Systems, Inc.

Name: FDA recall Z-2985-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-10

Class I · Ongoing

Class I FDA medical device recall by Bard Access Systems, Inc., initiated 2026-08-10. It names 2 FDA 510(k) clearances: K090102, K030268. Product: DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625200; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625240; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625300; DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626120; DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626150; DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626200; DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626240; Niagara Dual-Lumen Short-Term Curved Extension Dialysis Catheter, REF: 5766200. Reason: this is a downstream recall of class I recall RES 98777.

Recalling firm: Bard Access Systems, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2026-08-10
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

2 on FDA's record

K090102 — NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERSC.R. Bard, Inc.·cleared 2009-02-12
K030268 — NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERSC.R. Bard, Inc.·cleared 2003-07-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625200; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625240; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625300; DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626120; DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626150; DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626200; DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626240; Niagara Dual-Lumen Short-Term Curved Extension Dialysis Catheter, REF: 5766200

Reason for recall

this is a downstream recall of class I recall RES 98777

Data sourced from openFDA. This site is unofficial and independent of the FDA.