Bard Access Systems Recalls Provena Midline Catheters

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Bard Access Systems, Inc. is recalling 24,348 units of various Provena Midline Catheters due to a supplier recall of lidocaine ampoules manufactured under deficient practices.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on August 7, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.

What Happened

Bard Access Systems, Inc. initiated a voluntary recall of certain Provena Midline Catheters because lidocaine ampoules included or associated with the products were manufactured under deficient manufacturing practices by the supplier.

Which Products Are Affected

The recall covers 24,348 units of the following Provena Midline Catheters distributed worldwide, including U.S. nationwide (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, WY) and Belgium:

  • CK000880 Provena Midline Catheter 4 Fr Dual-Lumen (UDI-DI: 00801741188770, Lot: REKN2105)
  • S4153108BDP Provena Midline Catheter 3 Fr Single-Lumen (UDI-DI: 00801741154003, Lots: REKW2429, REKX1484)
  • S4153108BP Provena Midline Catheter 3 Fr Single-Lumen (UDI-DI: 00801741153990, Lot: REKW2494)
  • S4153108D Provena Midline Catheter 3 Fr Single-Lumen (UDI-DI: 00801741153952, Lots: REKP0118, REKX2225)
  • S4153108DCP Provena Midline Catheter 3 Fr Single-Lumen (UDI-DI: 00801741233258, Lot: REKX3430)
  • S4153108DGP Provena Midline Catheter 3 Fr Single-Lumen (UDI-DI: 00801741154027, Lots: REKQ0118, REKW1477)
  • S4254108BD Provena Midline Catheter 4 Fr Dual-Lumen (UDI-DI: 00801741154140, Lot: REKY0144)
  • S4254108BDP Provena Midline Catheter 4 Fr Dual-Lumen (UDI-DI: 00801741154164, Lots: REKW0447, REKW0953, REKX2214)
  • S4254108D Provena Midline Catheter 4 Fr Dual-Lumen (UDI-DI: 00801741154119, Lot: REKX3445)
  • S4254108DCP Provena Midline Catheter 4 Fr Dual-Lumen (UDI-DI: 00801741233234, Lot: REKW2430)
  • S4254108DGP Provena Midline Catheter 4 Fr Dual-Lumen (UDI-DI: 00801741154188, Lots: REKV3192, REKX3437)
  • SP4153108D Provena Midline Catheter 3 Fr Single-Lumen (UDI-DI: 00801741185052, Lot: REKW2448)
  • SP4153108DG Provena Midline Catheter 3 Fr Single-Lumen (UDI-DI: 00801741185069, Lot: REKW0959)

The Provena Midline Catheters are intended for short-term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media. Recall number: Z-2667-2026. Classification: Class II. Recall initiation date: May 21, 2026.

What You Should Do

No specific consumer action steps are provided in the recall notice.

Why This Matters

The recall affects over 24,000 catheter units distributed across the United States and internationally due to potential issues stemming from the supplier's lidocaine ampoules.

Source

FDA recall Z-2667-2026

Original source: FDA Official Notice ↗

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Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Bard Access Systems, Inc. is recalling 24,348 units of various Provena Midline Catheters due to a supplier recall of lidocaine ampoules manufactured under deficient practices.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.