The Recall Desk
HighFDA (Devices)·Z-1447-2025·Announced 2025-04-02

Medline procedure kits recalled for syringe quality defects

Medline Industries is recalling 1,711 procedure kits containing plastic syringes affected by manufacturing defects. The syringes may leak or break, posing a risk to patient safety 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: FDA Class II recall of medical device with identified manufacturing defects (leaks, breakage) that pose risk to patient health during procedures. No illnesses or injuries have been reported, meeting the criterion of risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries is recalling 1,711 medical procedure kits that contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. These syringes have manufacturing quality issues that were identified during a recall investigation.

The defective syringes may leak, break, or experience other quality problems during use, which could affect patient safety during medical procedures. The affected kits have been distributed nationwide in the United States and in Canada.

Healthcare facilities should immediately discontinue use of the recalled kits and contact Medline Industries for return or replacement options. The recall affects 22 different surgical procedure kit configurations, each with specific pack numbers and lot codes identified by the FDA. Facilities and patients should consult their medical team or procurement department if they have questions about whether they possess any of the affected kits.

The recalled product

Product
Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D; 2) CSMC/GYN LAPAROSCOPIC PACK-LF, Pack Number DYNJ0665103I; 3) DAVINCI PACK-RFD, Pack Number DYNJ47762O; 4) DAVINCI ROBOT PACK SLRMC, Pack Number DYNJ81236; 5) GENERAL ROBOTICS PACK, Pack
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical kits
Hazard
  • syringe-leak
  • syringe-breakage

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 DYNJ61061D: UDI/DI 10195327451509 (each) 40195327451500 (case)
  • Lot Number 23GMD257A
  • 2) Pack Number DYNJ0665103I: UDI/DI 10193489395211 (each) 40193489395212 (case)
  • Lot Number 23ABM287A
  • 3) Pack Number DYNJ47762O: UDI/DI 10195327478742 (each) 40195327478743 (case)
  • Lot Number 23IMF676A
  • 4) Pack Number DYNJ81236: UDI/DI 10195327096618 (each) 40195327096619 (case)
  • Lot Number 23LMH303A
  • 5) Pack Number DYNJ80546B: UDI/DI 10195327211097 (each) 40195327211098 (case)
  • Lot Number 23FBP444A
  • 6) Pack Number DYNJ43441C: UDI/DI 10193489323177 (each) 40193489323178 (case)
  • Lot Number 21LBG879A
  • 7) Pack Number DYNJ909936: UDI/DI 10195327511203 (each) 40195327511204 (case)
  • Lot Number 23JBI037Z
  • 8) Pack Number DYNJ63014A: UDI/DI 10193489245684 (each) 40193489245685 (case)
  • Lot Number 20BDB396A
  • 9) Pack Number DYNJ51739B: UDI/DI 10889942975884 (each) 40889942975885 (case)
  • Lot Number 22ABT041A
  • 10) Pack Number DYNJ84181: UDI/DI 10195327340360 (each) 40195327340361 (case)
  • Lot Number 23KMC229A

Distribution

Distributed nationwide across the United States.

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