The Recall Desk
HighFDA (Devices)·Z-1462-2025·Announced 2025-04-02

Medline Surgical Procedure Kits Recalled for Defective Plastic Syringes

Medline Industries is recalling 1,228 surgical procedure kits containing defective plastic syringes. The syringes may leak or break during use, potentially affecting patient safety.

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 a Class II medical device recall involving surgical kits with defective plastic syringes exhibiting leaks, breakage, and quality issues. No illnesses or injuries have been reported. The hazards represent a genuine risk to patient safety in surgical contexts, meeting the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling surgical procedure kits due to defective plastic syringes. The recall involves 1,228 units that have been distributed nationwide in the United States and in Canada.

The plastic syringes in these procedure kits have been identified with leaks, breakage, and other quality issues that may pose a risk to patient health during surgical procedures.

Healthcare facilities and surgical centers that have received these kits should identify affected units using the pack numbers and lot numbers provided to determine if their products are part of this recall.

The recalled product

Product
Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2) BREAST SURGERY FOAKS, Pack Number DYNJ63577C; 3) CHEST BREAST -LF, Pack Number DYNJCEN04C; 4) DIEP PACK, Pack Number DYNJ60669G; 5) FACE LIFT PACK, Pack Number DYNJ64670B; 6) FREE FLAP
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Procedure Kits
Hazard
  • syringe-leak
  • 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)

  • 1) Pack Number DYNJ0956628O: UDI/DI 10193489785869 (each) 40193489785860 (case)
  • Lot Number 21BBH575A
  • 2) Pack Number DYNJ63577C: UDI/DI 10193489267143 (each) 40193489267144 (case)
  • Lot Number 21BBI089A
  • 3) Pack Number DYNJCEN04C: UDI/DI 10193489805413 (each) 40193489805414 (case)
  • Lot Number 21BBI544A
  • 4) Pack Number DYNJ60669G: UDI/DI 10889942794942 (each) 40889942794943 (case)
  • Lot Number 21EME131A
  • 5) Pack Number DYNJ64670B: UDI/DI 10889942575701 (each) 40889942575702 (case)
  • Lot Number 21IME484A
  • 6) Pack Number DYNJ40647G: UDI/DI 10193489270976 (each) 40193489270977 (case)
  • Lot Number 21IMH836A
  • 7) Pack Number DYNJ0665560D: UDI/DI 10195327089795 (each) 40195327089796 (case)
  • Lot Number 22CMB464A
  • 8) Pack Number DYNJ40356A: UDI/DI 10193489228335 (each) 40193489228336 (case)
  • Lot Number 22JBF484Z
  • 9) Pack Number DYNJ0252232U: UDI/DI 10195327217334 (each) 40195327217335 (case)
  • Lot Number 22JBG465Z
  • 10) Pack Number DYNJ60232A: UDI/DI 10195327222451 (each) 40195327222452 (case)
  • Lot Number 22JBN921Z

Distribution

Distributed nationwide across the United States.

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