The Recall Desk
HighFDA (Devices)·Z-0779-2025·Announced 2025-01-08

Medline Surgical Procedure Kits Recalled for Non-Sterile Components

Medline is recalling custom surgical procedure kits containing non-sterile surgical components with potential endotoxin contamination. The recall affects 1,402 units distributed in the US, Canada, and UAE.

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 recall of surgical kits with non-sterile components and potential endotoxin contamination. This represents a risk-of-harm product, though no illnesses or injuries have been reported in the source material.

Plain-English summary

Medline Industries is recalling custom medical procedure kits that contain non-sterile Codman Surgical Patties and Surgical Strips, which may be contaminated with endotoxins. Affected kits include VP Shunt, Neuro Sponge, and Burr Hole Shunt procedure kits with specific lot numbers and UDI codes.

The recall involves 1,402 units distributed worldwide, including nationwide in the United States, as well as the UAE and Canada.

Endotoxin contamination in sterile surgical supplies poses a potential risk if the kits are used in procedures. Healthcare facilities and providers who have received these kits should contact Medline Industries for recall instructions and replacement products. These kits should not be used.

The recalled product

Product
Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF, REF DYNJ0713177; 3) BURR HOLE SHUNT PACK, REF DYNJ56819D; 4) BURR HOLE SHUNT PACK, REF DYNJ56819F; 5) BURR HOLE SHUNT PACK, REF DYNJ56819G; 6) RO VP SH
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Procedure Kits
Hazard
  • endotoxin-contamination
  • non-sterile

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 CDS983470D
  • UDI/DI 10193489275339 (EA) 40193489275330(CS)
  • Lot numbers: 20BDB519
  • 20EDA360
  • 20EDC040
  • 20GDA474
  • 20JDA107
  • 20KDA855
  • 21CDA110
  • 21EDA674
  • 21FDA748
  • 2) REF DYNJ0713177
  • UDI/DI 10889942085088 (EA) 40889942085089(CS)
  • Lot numbers: 19AKC072
  • 19HKC645
  • 19KKA304
  • 20FKA539
  • 3) REF DYNJ56819D
  • UDI/DI 10193489254273 (EA) 40193489254274(CS)
  • Lot numbers: 20AKA332

Distribution

Distributed nationwide across the United States.

Related recalls

Same category