FDA-Device2026-07-08Class IIPROCESSING DEFECT
Bard Access Systems PowerMidline Catheter recalled for deficient lidocaine ampoule manufacturing
What this means
Bard Access Systems is recalling PowerMidline Catheters (4 Fr Dual-Lumen) because the lidocaine ampoules included with these devices were manufactured under deficient manufacturing practices. The affected catheters were distributed nationwide and internationally.
- Check if you have one of the affected lot numbers: REKX0112, REKW0949, or REJZ1337
- Contact your medical facility or supplier for instructions on returning or replacing the product
- Do not use affected catheters until you receive guidance from your healthcare 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
2,844
Manufactured in
605 N 5600 W, N/A, Salt Lake City, UT, United States
Products
CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 P4254108 PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129278 P4254108D PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129353 The PowerMidline" Catheter is intended for short term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2663-2026More 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 Groshong NXT ClearVue 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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