The Recall Desk
HighFDA (Devices)·Z-1877-2026·Announced 2026-04-29

Medline Convenience Kits With Syringes Recalled for Unapproved Design Changes

Medline Industries is recalling Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects 270,311 units distributed nationwide and internationally.

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: The recall involves medical devices used in high-risk procedures (cardiac catheterization, angiography, interventional radiology) with design modifications made outside of FDA 510(k) clearance, posing a risk of harm. The source text does not report any adverse events or injuries, keeping the score at the maximum of 3 under the rubric.

Plain-English summary

Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL polycarbonate colored syringes. The products were subject to design changes that were not approved under the FDA 510(k) clearance pathway.

The affected kits include multiple SKUs used in cardiac catheterization, angiography, interventional radiology, and related medical procedures. A total of 270,311 units have been distributed worldwide, including across the United States, Canada, Panama, and Barbados.

Specific lot numbers and UDI-DI codes for the affected products are detailed in the FDA notice. Customers who have received these kits should review the lot numbers and product codes to determine if their inventory is affected.

Medline has initiated customer notification regarding this recall. Healthcare providers should contact Medline or the FDA for guidance on returned or replacement products, and should review their procedures for verifying product clearance status prior to use.

The recalled product

Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF DYNJ38395G ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665F DYNJ47665G ANGIO KIT PACK DYNJ83746 DYNJ83746A ANGIO PACK DYNJ30565G DYNJ51239C DYNJ66631A DYNJ6920
Manufacturer
Medline Industries, LP
Category
Medical Device — Cardiac/Interventional Radiology Kits
Hazard
  • unapproved-design-change
  • clearance-violation

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)

  • DYNJ21574L Lots 25ABP571 25ALA224 25CBL413
  • DYNJ26855G Lots 22KBH184 22KBH187 22KBW271 23CBU979 23DBJ420 23FBV657 23HBV978
  • DYNJ26855I Lots 25ABS101 25CBP637
  • DYNJ30565F Lots 22ADB192
  • DYNJ59898B Lots 22GBM877
  • DYNJ62983A Lots 21FME305 21GMA862 22CMB536 23CMF038
  • DYNJ0545064AA Lots 23DMD621 23EME923 23FMD499 23HMA183 23IMC062 23KMA689
  • DYNJ28082I Lots 23GBC376
  • DYNJ30565G Lots 25BMF623
  • DYNJ37389Q Lots 25BMB454 25CMD795 25EMD467
  • DYNJ37485D Lots 25AMJ305 25CMA151
  • DYNJ44293F Lots 22KBD454 23ABF404 23BBA548 23BBK630 23EBI351
  • DYNJ44293G Lots 24FBI497
  • DYNJ47665F Lots 23DMB165
  • DYNJ51697C Lots 23JBJ820 23JBV985 23KBK659 24ABY364 24ABY589 24CBI875 24DBS165
  • DYNJ56666D Lots 23CMG612
  • DYNJ62595C Lots 23GBR603
  • DYNJ62595D Lots 24ABW004 25ABM934
  • DYNJ62858C Lots 25DMH376
  • DYNJ63434D Lots 24ABQ391 25EBQ015

Distribution

Distributed nationwide across the United States.

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