The Recall Desk
HighFDA (Devices)·Z-2623-2024·Announced 2024-09-04

Medline procedure packs with syringes recalled due to leaks and breakage

Medline is recalling procedure packs containing Shenli syringes due to leaks, breakage, and quality issues that may pose risks to patient health. Over 1.6 million units have been distributed worldwide.

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: FDA Class II recall with identified quality defects (leaks and breakage) in medical syringes affecting over 1.6 million units and posing potential risk to patient health, though no illnesses or injuries have been reported, meeting the criteria for a risk-of-harm product.

Plain-English summary

Medline Industries is recalling procedure packs containing Shenli syringes due to identified quality issues. The affected packs are labeled with pack numbers DYNJ34129C, DYNJ54607A, and DYNJ61839B. In total, 1,679,067 units have been distributed worldwide.

The syringes are affected by an FDA Safety Alert issued on March 19, 2024. Quality defects identified include leaks, breakage, and other issues that may pose a risk to patient health. These defects could compromise the integrity and safety of medical procedures in which the syringes are used.

This recall affects healthcare facilities and medical professionals who use these procedure packs for patient care. The worldwide distribution pattern means the affected products may be in use across numerous medical settings.

Healthcare facilities and professionals who have received these procedure packs should immediately stop using the recalled products. Contact Medline Industries for guidance on product returns and replacement options.

The recalled product

Product
Medline procedure packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK, pack number DYNJ34129C, 2) FTMC LOCAL PACK-LF, pack number DYNJ54607A, 3) LOCAL PACK, pack number DYNJ61839B
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Syringes / Procedure Packs
Hazard
  • leakage
  • breakage
  • quality-defect

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)

  • DYNJ34129C
  • Lot Number 21GBT130
  • Lot Number 21LBL623
  • Lot Number 22ABM033
  • Lot Number 22ABX499
  • Lot Number 19BBD954
  • Lot Number 19DBZ455
  • Lot Number 19EBU077
  • Lot Number 19GBU537
  • Lot Number 22IBG550
  • Lot Number 19JBN034
  • Lot Number 20BBF056
  • Lot Number 23FBG792
  • Lot Number 23GBE376
  • Lot Number 20FBS002
  • Lot Number 23JBR570
  • Lot Number 23JBY629
  • Lot Number 23KBU960
  • Lot Number 23KBW607
  • Lot Number 20KBW597

Distribution

Distribution scope not specified by the agency.

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