Bard Access Systems PowerMidline Catheter Recall

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 16,887 PowerMidline Catheters distributed nationwide and in Belgium 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 specific PowerMidline Catheters after the supplier recalled lidocaine ampoules due to deficient manufacturing practices.

Which Products Are Affected

The recall covers 16,887 units of the following products with listed lot numbers:

  • CK000727 PowerMidline Catheter 4 Fr Single-Lumen (UDI-DI: 00801741138478), lots REKP2822, REKW2840, REKX3882
  • CK000729 PowerMidline Catheter 4 Fr Single-Lumen (UDI-DI: 00801741138713), lot REKW2434
  • P4153108D PowerMidline Catheter 3 Fr Single-lumen (UDI-DI: 00801741108747), lot REKW0907
  • P4154108 PowerMidline Catheter 4 Fr Single-Lumen (UDI-DI: 00801741108754), lots REKW2479, REKX3439
  • P4154108D PowerMidline Catheter 4 Fr Single-Lumen (UDI-DI: 00801741108761), lots REKP0895, REKX0665, REKX2216, REKY1281

The PowerMidline Catheter is intended for short-term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media. Distribution includes the United States 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. Recall number Z-2662-2026, Class II, ongoing.

What You Should Do

Consumers should follow guidance from the recalling firm or FDA regarding affected devices.

Why This Matters

The recall affects over 16,000 catheter units distributed across the U.S. and internationally due to a supplier manufacturing issue.

Source

FDA recall Z-2662-2026: https://www.fda.gov

Original source: FDA Official Notice ↗

All FDA Recalls →

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 16,887 PowerMidline Catheters distributed nationwide and in Belgium 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.