The Recall Desk
HighFDA (Devices)·Z-0160-2025·Announced 2024-10-30

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

Medline Industries is recalling 2,740 surgical convenience kits with breather pouches that may result in non-sterile product if the vendor seal is opened. The recall affects 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 medical device recall with no reported illnesses or injuries. The recall involves surgical instruments where potential loss of sterility poses a risk of serious harm, meeting the rubric criterion for high severity: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling certain medical procedure convenience kits used for various surgical procedures, including tonsil and adenoid removal, ear surgery, and other ear, nose, and throat (ENT) procedures.

The recall was issued because certain kits that were packaged in breather pouch lot 323080002 may result in non-sterile product if the vendor seal of the pouch is opened or unsealed. Non-sterile surgical instruments could pose a contamination risk if used in medical procedures.

The recall affects approximately 2,740 units distributed nationwide in the United States, as well as in Canada and Panama. Healthcare facilities and professionals who have received these kits should identify units with the affected breather pouch lot number 323080002 and prevent their use to ensure surgical procedures use only sterile instruments.

The recalled product

Product
Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF CDS982091I; 2) TONSIL CDS, REF CDS984492B; 3) RV T&A PACK-LF, REF DYNJ0798129I; 4) DIRECT MICRO LARYNG PK-LF, REF DYNJ30591I; 5) APU LINE PACK, REF DYNJ37171A; 6) T&A PACK-LF, REF DYNJ40
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical procedure kits
Hazard
  • non-sterile
  • contamination

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 CDS982091I
  • UDI/DI 40193489741644 (each)
  • 10193489741643 (case)
  • Lot Numbers: 24BBA623
  • 2) REF CDS984492B
  • UDI/DI 40193489637183 (each)
  • 10193489637182 (case)
  • Lot Numbers: 24ABB114
  • 3) REF DYNJ0798129I
  • UDI/DI 40195327226511 (each)
  • 10195327226510 (case)
  • Lot Numbers: 23KBB859
  • 4) REF DYNJ30591I
  • UDI/DI 40193489962841 (each)
  • 10193489962840 (case)
  • Lot Numbers: 24ABD228
  • 5) REF DYNJ37171A
  • UDI/DI 40884389750620 (each)
  • 10884389750629 (case)
  • Lot Numbers: 23KBD998

Distribution

Distributed nationwide across the United States.

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