The Recall Desk
HighFDA (Devices)·Z-0173-2025·Announced 2024-10-30

Medline Medical Procedure Kits Recalled Due to Non-Sterile Product Risk

Medline is recalling certain convenience kits for medical procedures due to potential non-sterile product risk if the breather pouch seal is compromised. The recall affects 51 units distributed in the US, Canada, and Panama.

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 recall for a potential sterility hazard in medical procedure kits. The source text does not report any illnesses, injuries, or confirmed contamination. The hazard is theoretical—risk of non-sterile product if the pouch seal is compromised—making this a risk-of-harm product without reported injury.

Plain-English summary

Medline Industries is recalling certain medical procedure convenience kits because of a packaging defect that could result in non-sterile product exposure. The recalled kits were packaged in breather pouches with lot number 323080002. If the vendor seal on these pouches is opened or unsealed, there is potential for the product to become non-sterile.

The recall affects two product lines: NEURO PACK (REF DYNJ37909A, Lot 24ABG035) and SHUNT PACK (REF DYNJ40040C, Lot 23KBB863). A total of 51 units have been identified. These kits were distributed worldwide, including throughout the United States, Canada, and Panama.

Consumers, healthcare providers, and medical facilities who possess these kits should stop using them and contact Medline for instructions on return or replacement. The risk to patients exists if the pouch seal has been compromised and the product has been used.

The recalled product

Product
Medline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF DYNJ37909A; b) SHUNT PACK, REF DYNJ40040C
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical kit
Hazard
  • non-sterile-product
  • packaging-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 (8)

  • a) REF DYNJ37909A
  • UDI/DI 40193489675451 (each)
  • 10193489675450 (case)
  • Lot Numbers: 24ABG035
  • b) REF DYNJ40040C
  • UDI/DI 40889942683971 (each)
  • 10889942683970 (case)
  • Lot Numbers: 23KBB863

Distribution

Distributed nationwide across the United States.

Related recalls

Same category