FDA-Device2026-07-08Class IIPROCESSING DEFECT
Bard Groshong NXT ClearVue Catheter recalled for deficient lidocaine ampoule manufacturing
What this means
Lidocaine ampoules supplied with Bard's Groshong NXT ClearVue Catheter were manufactured under deficient practices. The supplier has initiated a recall of the affected ampoules due to these manufacturing concerns.
- Check if you have lot REKY1686 of the Groshong NXT ClearVue Catheter 4 Fr Single-Lumen
- Contact your healthcare provider or hospital if you have received this product
- Do not use the recalled lidocaine ampoules; consult with your medical team for guidance
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
120
Manufactured in
605 N 5600 W, N/A, Salt Lake City, UT, United States
Products
7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035258 The Groshong¿ NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2665-2026More 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 Access Systems thoracentesis and paracentesis trays recalled for deficient lidocaine manufacturing
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