The Recall Desk
HighFDA (Devices)·Z-0510-2025·Announced 2024-12-04

Medline Epidural Catheter Kits Recalled Due to Connector Position Defect

Medline is recalling over 5,900 epidural catheter kits because the connectors may not open fully, preventing proper catheter insertion. The recall affects units distributed nationwide and internationally.

What this means for you

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 FDA Class II recall involves a functional defect in which connectors may not fully open, preventing proper catheter insertion. No injuries or illnesses have been reported, but the device malfunction poses a clear risk-of-harm to proper medical procedure execution, meriting a High severity rating per the rubric.

Plain-English summary

Medline Industries is recalling 20G epidural catheter kits due to a connector defect. The recalled kits are labeled as EPICATH19 or EPICATH20 and contain approximately 5,975 units total.

The connectors in these kits may not be in the fully open position when supplied. If a connector is not fully open, it may not allow the catheter to be inserted as intended, potentially delaying or preventing the intended medical procedure.

The affected kits were distributed nationwide in the United States and internationally to Bermuda, Canada, Panama, the United Arab Emirates, and the US Virgin Islands. Specific lot numbers for both products have been identified by the manufacturer.

Healthcare facilities should check their inventory for the identified lot numbers and verify that all connectors are fully open before use. Any affected units should be isolated and not used. Contact Medline Industries or the FDA for instructions regarding return or replacement of recalled kits.

The recalled product

Product
MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STERILE, REF EPICATH20
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Epidural Catheters
Hazard
  • connector-malfunction
  • insertion-failure

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 (20)

  • Codes: 1) EPICATH19
  • UDI/DI 10889942358311(each) 40889942358312(case)
  • Lot Numbers: 22FBX111
  • 22FBY472
  • 23FBT886
  • 23GBL403
  • 23GBO700
  • 23GBO701
  • 23GBO702
  • 2) EPICATH20
  • UDI-DI: 10889942358328 (each) 40889942358329 (case)
  • Lot Numbers: 22FBN457
  • 22HBM699
  • 22HBN345
  • 23CBF321
  • 23DBM670
  • 23FBK248
  • 23GBO703
  • 23GBO704 23GBO705
  • 23KBG553

Distribution

Distributed nationwide across the United States.

Related recalls

Same category