HIGH

Abbott Catheters Recalled Over Risk of Infection and Embolism

Abbott recalled reprocessed steerable diagnostic catheters on December 22, 2025, after discovering potential contamination. The devices may contain small particles that pose risks of systemic infection or embolism. A total of 311 units are affected nationwide.

Quick Facts at a Glance

Recall Date
December 22, 2025
Hazard Level
HIGH
Brand
Medline Industries, LP
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter

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About This Product

The Abbott Inquiry Steerable Diagnostic Catheters are used in various medical procedures for diagnostic purposes. Healthcare providers purchase these devices to assist in minimally invasive surgeries.

Why This Is Dangerous

The reprocessed catheters may contain residual particles that can trigger inflammatory responses in patients. This contamination can lead to severe health risks, including systemic infections and embolic events.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall affects healthcare providers and patients relying on these devices for medical procedures, posing significant health risks if not addressed.

Practical Guidance

How to identify if yours is affected

  1. Check the model number of your catheter against the recalled list.
  2. Look for any notification letters from Medline Industries regarding the recall.
  3. Consult your healthcare provider for further identification.

Where to find product info

Model numbers and lot information can be found on the packaging or the device itself.

What timeline to expect

Expect a timeline of 4-6 weeks for refunds or replacements.

If the manufacturer is unresponsive

  • Document your communications with the manufacturer.
  • Follow up with your healthcare provider for alternative solutions.
  • Consider filing a complaint with the FDA if the manufacturer remains unresponsive.

How to prevent similar issues

  • Look for single-use diagnostic devices in the future.
  • Ensure that any medical device purchased is FDA-approved and certified.
  • Consult healthcare professionals for the latest safety recalls before use.

Documentation advice

Keep all receipts, letters from the manufacturer, and any medical records related to the use of the recalled product.

Product Details

The recalled products include multiple models of Abbott Inquiry Steerable Diagnostic Catheters. Specific models include 81105RH, 81172RH, 81202RH, 81483RH, and others. These devices were distributed across the United States.

Key Facts

  • Recall date: December 22, 2025
  • Total affected units: 311
  • Potential risks include systemic infection and embolism
  • Class I recall indicates serious health risk
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeSteerable Diagnostic Catheter
Sold At
Multiple Retailers

Product Details

Model Numbers
81105RH UDI-DI 10197344133253 Lot EP250618
81172RH UDI-DI 10197344133284 Lot EP250618
81202RH UDI-DI 10197344133307 Lot EP250618
81483RH UDI-DI 10197344133444 Lot EP250618
81102RH UDI-DI (case) 20197344133236¿ (ea) 10197344133239 Lot EP250618
+10 more
Affected States
ALL
Report Date
February 18, 2026
Recall Status
ACTIVE

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