The Recall Desk
HighFDA (Devices)·Z-1448-2025·Announced 2025-04-02

Medline C-section procedure kits recalled for syringe quality defects

Medline is recalling C-section procedure kits because plastic syringes in the kits may leak or break. The defect was identified in connection with an FDA safety alert and poses a potential risk to patient health.

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 medical device recall. Although no illnesses or injuries have been reported, the defect poses a potential risk to patient health in a surgical context, warranting a High severity classification.

Plain-English summary

Medline Industries, LP is recalling 605 units of C-section procedure kits. The recall affects 10 different product variations with specific pack numbers and lot numbers distributed nationwide in the US and Canada.

The plastic syringes contained in these kits are affected by an FDA Safety Alert issued on March 19, 2024. Identified defects include leaks, breakage, and other quality issues that may pose a risk to patient health.

Healthcare facilities and medical professionals who received these kits should identify affected products using the provided pack numbers and lot numbers.

Affected parties should contact Medline Industries, LP for further instructions regarding the recalled kits.

The recalled product

Product
Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; 2) C SECTION PACK, Pack Number DYNJ48483B; 3) C SECTION PACK, Pack Number DYNJ61573; 4) C SECTION PACK, Pack Number DYNJ66801; 5) C SECTION PACK-LF, Pack Number DYNJ0367951P; 6) C SECTION PACK-LF
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Procedure Kits
Hazard
  • leak
  • breakage
  • device-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)

  • 1) Pack Number DYNJ57622: UDI/DI 10889942757244 (each) 40889942757245 (case)
  • Lot Number 20LMF902A
  • 2) Pack Number DYNJ48483B: UDI/DI 10193489659405 (each) 40193489659406 (case)
  • Lot Number 20CKB746A
  • 3) Pack Number DYNJ61573: UDI/DI 10193489601077 (each) 40193489601078 (case)
  • Lot Number 22CMB584A
  • 4) Pack Number DYNJ66801: UDI/DI 10193489384000 (each) 40193489384001 (case)
  • Lot Number 22GBW063A
  • 5) Pack Number DYNJ0367951P: UDI/DI 10193489966923 (each) 40193489966924 (case)
  • Lot Number 21IMH644A
  • 6) Pack Number DYNJ55345D: UDI/DI 10195327173722 (each) 40195327173723 (case)
  • Lot Number 22GBJ830A
  • 7) Pack Number DYNJ04521J: UDI/DI 10193489555837 (each) 40193489555838 (case)
  • Lot Number 21HMA851A
  • 8) Pack Number DYNJ32632F: UDI/DI 10193489888966 (each) 40193489888967 (case)
  • Lot Number 21IMD959A
  • 9) Pack Number DYNJ65961B: UDI/DI 10193489984309 (each) 40193489984300 (case)
  • Lot Number 23LMG679A
  • 10) Pack Number DYNJ38582J: UDI/DI 10193489528244 (each) 40193489528245 (case)
  • Lot Number 21IMF094A

Distribution

Distributed nationwide across the United States.

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