The Recall Desk
HighFDA (Devices)·Z-2701-2024·Announced 2024-08-28

Medline medical procedure kits recalled for dimensional variation

Medline is recalling medical procedure kits due to a slight dimensional variation that may cause fitting difficulties. No injuries or illnesses have been reported.

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 medical device recall where the hazard is theoretical (no injuries, illnesses, or deaths reported). The dimensional fitting issue in medical procedure kits qualifies as a risk-of-harm product category where harm has not yet been reported, placing this at the High (3) level per the rubric.

Plain-English summary

Medline Industries, LP is recalling multiple medical procedure kits due to a slight dimensional variation. The affected kits include Heart Anesthesia Setup, Endo Kits (Upper and Lower), Pacemaker Kit, and Vascular Kits, identified by their reference numbers: DYNJ902752C, DYKE1872A, DYKE1921A, DYKE1922A, DYNJ901681D, DYNJ905515D, DYNJ902387K, and DYNJS2035C.

The dimensional variation may cause increased difficulty when inserting the kits into their outer canisters. No injuries, illnesses, or deaths have been reported related to this dimensional issue.

Approximately 26,096 units have been distributed worldwide, including the entire United States and the countries of Canada, Mexico, Panama, El Salvador, Colombia, Singapore, Qatar, and Oman.

The FDA has classified this as a Class II recall. Affected products can be identified by their reference numbers and lot numbers. Individuals with these kits should refer to the official recall notice for specific lot information and contact Medline Industries for guidance.

The recalled product

Product
Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO KIT, REF DYKE1921A, d) PACEMAKER, REF DYNJ901681D, e) UPPER ENDO KIT, REF DYKE1922A, f) VASCULAR, REF DYNJ905515D, g) VASCUALR,
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Medical Procedure Kits
Hazard
Affected units
26,096

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)

  • a) REF DYNJ902752C
  • UDI/DI 40195327226993 (case)
  • 10195327226992 (unit)
  • Lot Numbers: 22IBA627
  • 22JBE922
  • 22JBP917
  • 22KBJ447
  • 23BBB611
  • 23CBC455
  • 23EBF908
  • 23FBV764
  • 23GBW761
  • 23IBR157
  • b) REF DYKE1872A
  • UDI/DI 40195327330027 (case)
  • 10195327330026 (unit)
  • Lot Numbers: 23CBB846
  • 23CBK197
  • 23DBK952
  • 23FBD020

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 21 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 21 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · dimensional variation

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