FDA-Device2026-07-08Class IIPROCESSING DEFECT
Bard DuoGlide dialysis catheter recalled due to defective lidocaine ampoules
What this means
The lidocaine ampoules included with Bard's DuoGlide Short-Term Dialysis Catheters were manufactured under deficient practices and are being recalled by the supplier. The affected catheters are used for temporary vascular access during hemodialysis and related therapies.
- Check if you have lot REKY0255 of the DuoGlide catheter.
- Do not use the included lidocaine ampoule if manufacturing deficiencies are confirmed.
- Contact your healthcare provider or hospital for guidance on whether your catheter is affected and what alternatives are available.
- Retain the catheter package and lot number for reference when you contact your provider.
The agency's original wording
Hazard
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium.
Affected count
310
Manufactured in
605 N 5600 W, N/A, Salt Lake City, UT, United States
Products
5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 The intended use of the Short-Term Dialysis Catheter is attaining temporary/short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, or apheresis therapy via the jugular, subclavian, or femoral vein.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2657-2026More Bard Access Systems, Inc. recalls
- FDA-Device2026-07-08Bard Access Systems Power-Trialysis dialysis catheters recalled for deficient lidocaine ampoule manufacturing
- FDA-Device2026-07-08Bard Access Systems PowerPICC catheters recalled for deficient lidocaine manufacturing
- FDA-Device2026-07-08Bard Access Systems soft tissue biopsy trays recalled for defective lidocaine ampoules
- FDA-Device2026-07-08Bard Access Systems PowerMidline Catheter recalled for deficient lidocaine ampoule manufacturing
- FDA-Device2026-07-08Bard Groshong NXT ClearVue Catheter recalled for deficient lidocaine ampoule manufacturing
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