Recall Z-2662-2026— Bard Access Systems, Inc.

Name: FDA recall Z-2662-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-21

Class II · Ongoing

Class II FDA medical device recall by Bard Access Systems, Inc., initiated 2026-05-21. It names one FDA 510(k) clearance: K153393. Product: CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 CK000729 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138713 P4153108D PowerMidline Catheter 3 Fr Single-lumen UDI-DI Code: 00801741108747 P4154108 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108754 P4154108D PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108761 The PowerMidline" Catheter is intended for short term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media.. Reason: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier..

Recalling firm: Bard Access Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-05-21
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K153393 — PowerMidline CatheterC.R. Bard, Inc.·cleared 2016-06-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 CK000729 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138713 P4153108D PowerMidline Catheter 3 Fr Single-lumen UDI-DI Code: 00801741108747 P4154108 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108754 P4154108D PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108761 The PowerMidline" Catheter is intended for short term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media.

Reason for recall

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Data sourced from openFDA. This site is unofficial and independent of the FDA.