Critical FDA (Devices)·Z-1320-2026·Announced 2026-02-18

Reprocessed Inquiry catheters recalled over residual material particles inside

Medline is recalling 311 units because these lots of reprocessed catheters may contain small particles of residual material.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.

Plain-English summary

Reprocessed Abbott Inquiry Steerable Diagnostic Catheters, covering the 10 electrode 2-5-2mm catheters 81105RH and 81172RH and the 20 electrode 2-10-2mm catheter 81202RH, among the catalog numbers listed in the enforcement record are being recalled by Medline Industries, LP.

The record states these lots of reprocessed catheters may contain small particles of residual material. It states that 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. The record notes this is an expansion of recall Z-2610/2614-2025.

The record lists 311 units, with UDI-DI codes and lot numbers recorded in the enforcement record. Distribution was nationwide in the United States. The FDA has classified the action as Class I, its most serious category.

Facilities should quarantine affected stock and follow Medline's instructions.

The recalled product

Product: Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81105RH 81172RH; Abbott Inquiry Steerable Diagnostic Catheter 20 Elec. 2-10-2mm 81202RH; Abbott Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm
Manufacturer: Medline Industries, LP
Category: Medical Device — Reprocessed catheter
Hazard: residual-material
reprocessed-device
embolism-risk
infection-risk
class-i
Affected units: 311

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

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
81532RH UDI-DI 10197344133529 Lot EP250618
81107RH UDI-DI 10197344133260 Lot EP250618
81402RH UDI-DI 10197344133352 Lot EP250618
81404RH UDI-DI 10197344133376 Lot EP250618
81405RH UDI-DI 10197344133383 Lot EP250618
81474RH UDI-DI 10197344133437 Lot EP250618
81473RH UDI-DI 10197344133420 Lot EP250618

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · Medline Industries, LP

See all →

High
Medline Convenience Kits Recalled for Potential Applicator Seal Defects
FDA (Devices) · 2026-09-09
Severe
Medline Blood Draw and Phlebotomy Kits Recalled for Sterility Breach
FDA (Devices) · 2026-09-09
High
Medline Blood Culture Kits Recalled Due to Potential Seal Defects
FDA (Devices) · 2026-09-09
Severe
Medline Eye and Cataract Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
High
Medline Convenience Kits Recalled Due to Potential Packaging Seal Defects
FDA (Devices) · 2026-09-09

Same hazard · residual material