PowerMidline Catheters Recalled for Deficient Manufacturing Practices
Bard Access Systems is recalling PowerMidline Catheters due to lidocaine ampoules being manufactured under deficient manufacturing practices. The catheters are used for short-term peripheral intravenous access and have been distributed nationwide and internationally.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall, and the source text does not report any illnesses or injuries. The hazard relates to deficient manufacturing practices affecting lidocaine ampoules, which constitutes a quality/safety concern but falls within the Moderate category per the rubric for Class II recalls without reported adverse events.
Plain-English summary
Bard Access Systems, Inc. is recalling PowerMidline Catheters because the lidocaine ampoules used in these devices were manufactured under deficient manufacturing practices.
The affected products include multiple models and catalog numbers of PowerMidline Catheters (3 Fr and 4 Fr Single-Lumen), which are intended for short-term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media. Approximately 16,887 units have been distributed.
The recalled devices were distributed nationwide across all U.S. states, the District of Columbia, Puerto Rico, and internationally to Belgium. Specific lot numbers are identified for each product model in the FDA recall database.
Patients and healthcare providers who have received or used these catheters should contact their healthcare provider or Bard Access Systems for instructions on next steps. More information is available through the FDA recall notice.
The recalled product
- 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
- Manufacturer
- Bard Access Systems, Inc.
- Hazard
- deficient-manufacturing
- lidocaine-quality
Distribution
Distributed nationwide across the United States.
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