The Recall Desk
HighFDA (Devices)·Z-0179-2025·Announced 2024-10-30

Medline medical procedure kits recalled due to potential non-sterile packaging

Medline is recalling 2,371 medical procedure convenience kits because certain kits packaged in specific breather pouches may contain non-sterile product if the seal is compromised.

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 a Class II FDA recall for medical procedure kits with a potential sterility issue—a risk-of-harm product category. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).

Plain-English summary

Medline Industries is recalling 2,371 medical procedure convenience kits due to a packaging issue that could result in non-sterile product. The affected kits were packaged in breather pouches with lot number 323080002. If the vendor seal on these pouches is opened or unsealed, the sterility of the medical equipment inside may be compromised.

The recalled kits include 27 different product models used in various orthopedic, cardiovascular, and other medical procedures. They were distributed worldwide, including throughout the United States, Canada, and Panama.

Healthcare facilities and users in possession of affected kits should verify the breather pouch lot number and take appropriate action based on their facility's protocols for handling potentially non-sterile medical equipment.

The recalled product

Product
Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND/FOOT CDS, REF CDS984003A; 3) SPECIAL PROCEDURE PACK, REF DYNJ32639C; 4) PK-ORTHO-MINOR, REF DYNJ39547B; 5) ANT CERV ADD ON PACK, REF DYNJ41229C; 6) NAV
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Procedure Kits
Hazard
Affected units
2,371

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 CDS982519W
  • UDI/DI 40195327389971 (each)
  • 10195327389970 (case)
  • Lot Numbers: 24BBQ775
  • 2) REF CDS984003A
  • UDI/DI 40888277002891 (each)
  • 10888277002890 (case)
  • Lot Numbers: 24ABG354
  • 3) REF DYNJ32639C
  • UDI/DI 40889942919223 (each)
  • 10889942919222 (case)
  • Lot Numbers: 23KBE944
  • 4) REF DYNJ39547B
  • UDI/DI 40193489760485 (each)
  • 10193489760484 (case)
  • Lot Numbers: 23LBO506
  • 5) REF DYNJ41229C
  • UDI/DI 40195327609727 (each)
  • 10195327609726 (case)
  • Lot Numbers: 24ABK563

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 33 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 33 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · non sterile

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