The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0508-2025·Announced 2024-12-04

Medline Nexus Catheter Connectors May Fail to Open Properly

Medline recalls 1,975 NEXUS catheter connectors that may not fully open, preventing proper catheter insertion. Affected units were distributed nationwide and internationally.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses or injuries. The hazard is a functional defect that could prevent proper catheter insertion, presenting a risk of harm if the device fails to operate as intended. Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High (3).

Plain-English summary

Medline Industries is recalling 1,975 units of the NEXUS 19/20G Catheter Connector (SKU REF NEXCONNECT). The connector is a medical device used for catheter insertion and placement in healthcare settings.

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position. This defect could prevent proper catheter placement during medical procedures.

The affected connectors were distributed nationwide in the United States as well as internationally to Bermuda, Canada, Panama, the United Arab Emirates, and the U.S. Virgin Islands. Specifically affected are units with these lot numbers: 21ABD173, 21EBC720, 21GBG632, 21HBF316, 21IBH392, 21IBM516, 21JBJ902, 21JBP187, 22IBL115, 22KBD213, 22OBI434, 23ABA553, 23ABO991, 23BBG757, 23CBO551, and 23EBT535. The device identifiers (UDI/DI) are 10193489490312 for individual units and 40193489490313 for cases.

Affected healthcare facilities and individuals should discontinue use of these connectors immediately and contact Medline Industries for replacement units.

The recalled product

Product
MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter Connector
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Catheter Connector
Hazard
Affected units
1,975

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 (18)

  • UDI/DI 10193489490312 (each)
  • 40193489490313 (case)
  • Lot Numbers: 21ABD173
  • 21EBC720
  • 21GBG632
  • 21HBF316
  • 21IBH392
  • 21IBM516
  • 21JBJ902
  • 21JBP187
  • 22IBL115
  • 22KBD213
  • 22OBI434
  • 23ABA553
  • 23ABO991
  • 23BBG757
  • 23CBO551
  • 23EBT535

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 8 recalled by MEDLINE INDUSTRIES, LP - Northfield 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 8 products in this recall →

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