The Recall Desk
HighFDA (Devices)·Z-0161-2025·Announced 2024-10-30

Medline medical procedure kits recalled for potential sterility breach

Medline medical procedure convenience kits with certain breather pouches may lose sterility if the vendor seal is opened. Approximately 5,972 units were 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: FDA Class II medical device recall involving potential loss of sterility in surgical procedure kits. No illnesses or injuries have been reported; the hazard is theoretical but represents a significant risk for patients undergoing medical procedures.

Plain-English summary

Medline Industries is recalling multiple medical procedure convenience kits totaling approximately 5,972 units. The affected kits were packaged in breather pouches with lot number 323080002.

The kits are being recalled because if the vendor seal on the breather pouch is opened or unsealed, the product inside may become non-sterile. These convenience kits are intended to be used for various medical procedures and must remain sterile for safe use.

The kits were distributed worldwide, including throughout the United States, Canada, and Panama. They were distributed to healthcare facilities and medical suppliers.

Consumers and healthcare facilities that have received kits with breather pouch lot 323080002 should not use them and should contact Medline Industries for instructions on return or replacement.

The recalled product

Product
Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS983525D; 3) CYSTO PACK-LF, REF DYNJ25834B; 4) CYSTO PACK, REF DYNJ35569C; 5) PAVILION MINOR PACK, REF DYNJ40724D; 6) CYSTOSCOPY PACK, REF DYNJ41105C; 7)
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Procedure Kits
Hazard
  • non-sterile-product
  • packaging-seal-defect
  • infection-risk

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) REF CDS983525D
  • UDI/DI 40195327429905 (each) 10195327429904 (case)
  • Lot Numbers: 24ABW238
  • 2) REF CDS983525D
  • Lot Numbers: 23KBU714
  • 3) REF DYNJ25834B
  • UDI/DI 40193489849555 (each) 10193489849554 (case)
  • Lot Numbers: 24ABG332
  • 4) REF DYNJ35569C
  • UDI/DI 40195327498253 (each) 10195327498252 (case)
  • Lot Numbers: 23LBL736
  • 5) REF DYNJ40724D
  • UDI/DI 40195327420773 (each) 10195327420772 (case)
  • Lot Numbers: 24ABG713
  • 6) REF DYNJ41105C
  • UDI/DI 40193489969659 (each) 10193489969658 (case)
  • Lot Numbers: 24ABA628
  • 7) REF DYNJ42132A
  • UDI/DI 40195327385270 (each) 10195327385279 (case)
  • Lot Numbers: 23LBS108

Distribution

Distributed nationwide across the United States.

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