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

Source: FDA · United States

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Medline Industries, LP has issued a Class I recall for 311 reprocessed Abbott Inquiry Steerable Diagnostic Catheters that may contain residual material, posing serious health risks.

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

This notice was issued by FDA on February 24, 2026 and geographically references United States. Its severity classification of "high" 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

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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

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medline Industries, LP has issued a Class I recall for 311 reprocessed Abbott Inquiry Steerable Diagnostic Catheters that may contain residual material, posing serious health risks.
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 "high" severity. Take precautions and monitor for updates.
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.