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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.

Official notice
Medline Industries, LPHealth & Personal CareMedical Devices81105RH UDI-DI 10197344133253 Lot EP25061881172RH UDI-DI 10197344133284 Lot EP25061881202RH UDI-DI 10197344133307 Lot EP250618

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
December 22, 2025
Status
ACTIVE
Severity
8/10

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Medline Industries, LP
Product type
Steerable Diagnostic Catheter
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, 81104RH UDI-DI 10197344133246 Lot EP250618, 81174RH UDI-DI 10197344133291 Lot EP250618, 81531RH UDI-DI 10197344133512 Lot EP250618 +7 more
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    December 22, 2025

  2. Reported by FDA DEVICE

    February 18, 2026

  3. RecallRadar source check

    February 25, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

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

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.

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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

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

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

Product Classification

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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