The Recall Desk
HighFDA (Devices)·Z-0509-2025·Announced 2024-12-04

MEDLINE Epidural and Spinal Anesthesia Procedure Kits: Connector Insertion Issue

Multiple MEDLINE procedure kits used for epidural and spinal anesthesia have connectors that may not open fully, preventing proper catheter insertion during medical procedures.

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 is an FDA Class II recall affecting medical devices critical to anesthesia delivery. The connector malfunction could prevent proper catheter insertion and interfere with patient care. However, no injuries or illnesses have been reported, making this a risk-of-harm scenario with theoretical rather than documented harm.

Plain-English summary

MEDLINE INDUSTRIES, LP is recalling multiple procedure kits used for epidural anesthesia, spinal anesthesia, combined spinal-epidural procedures, and continuous epidural pain management. The affected kits include 74 different product configurations identified by specific reference numbers and lot codes.

The connectors in these kits may not open to their fully open position, which could prevent catheters from being inserted as intended. This defect could interfere with proper delivery of anesthesia or pain management medication during medical procedures.

The recalled kits were distributed nationwide in the United States, as well as to Bermuda, Canada, Panama, the United Arab Emirates, and the U.S. Virgin Islands. Specific lot numbers have been identified for each product configuration and are listed in the FDA recall notice.

Healthcare providers and facilities using these kits should immediately stop using the affected lot numbers and contact MEDLINE INDUSTRIES for replacement products or further instructions. Patients who may have received procedures using potentially affected kits should consult with their healthcare provider if they have concerns about their care.

The recalled product

Product
MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268C; 3) FEMORAL BLOCK TRAY, REF DYNJRA1739A; 4) FEMORAL BLOCK TRAY, REF DYNJRA1739B; 5) 18G CPNB 20G STYLETED CATHETER, REF DYNJRA1
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Anesthesia and Pain Management Kits
Hazard
  • connector-failure
  • 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) DYNJRA1268B
  • UDI/DI 10193489370485 (each) 40193489370486 (case)
  • Lot Numbers: 20FLA512
  • 20HLA422
  • 20ILA296
  • 20ILA327
  • 20LLA223
  • 21ALA087
  • 21CLA525
  • 2) DYNJRA1268C
  • UDI/DI 10193489905830 (each) 40193489905831 (case)
  • Lot Numbers: 21ELA224
  • 21ELA333
  • 21GLA292
  • 21GLA895
  • 21HLA924
  • 21ILA773
  • 21JLA824
  • 22ALA237
  • 22BLA899

Distribution

Distributed nationwide across the United States.

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