Medline Industries Recalls Reprocessed Abbott Inquiry Steerable Diagnostic Catheters Due to Potential Contamination

What Happened

Medline Industries, LP has initiated a voluntary Class I recall of several models of reprocessed Abbott Inquiry Steerable Diagnostic Catheters. The recall was prompted by the discovery that certain lots may contain small particles of residual material. This is an expansion of a previous recall (Z-2610/2614-2025).

Which Products Are Affected

The recall involves 311 units distributed nationwide across the United States. All affected products are associated with Lot EP250618. The specific models and UDI-DIs include:

• 81105RH / 81172RH: 10 Elec. 2-5-2mm (UDI-DI 10197344133253, 10197344133284)
• 81202RH: 20 Elec. 2-10-2mm (UDI-DI 10197344133307)
• 81483RH: 4 Elec. 5mm (UDI-DI 10197344133444)
• 81102RH / 81104RH / 81174RH / 81531RH / 81532RH: 10 Elec. 2-5-2mm (UDI-DI 10197344133239, 10197344133246, 10197344133291, 10197344133512, 10197344133529)
• 81107RH: 10 Elec. 5mm (UDI-DI 10197344133260)
• 81402RH / 81404RH / 81405RH / 81474RH: 4 Elec. 2-5-2mm (UDI-DI 10197344133352, 10197344133376, 10197344133383, 10197344133437)
• 81473RH: 4 Elec. 5mm (UDI-DI 10197344133420)

What You Should Do

Medline Industries began notifying customers of the issue via letter on December 22, 2025. Healthcare facilities and providers should immediately check their inventory for the affected lot number (EP250618) and follow the instructions provided in the firm’s notification letter regarding the return or disposal of the devices. For more information, contact Medline Industries, LP at their Northfield, Illinois headquarters.

Why This Matters

This is a Class I recall, indicating that the use of these devices poses a serious health risk. The presence of residual material in the catheters can lead to inflammatory responses, systemic infections, or thrombus reactions, which may result in life-threatening conditions such as cerebral embolism, pulmonary embolism, or deep vein thrombosis.

Source

FDA Recall Event ID 98277 - Recall Number: Z-1320-2026