The Recall Desk
HighFDA (Devices)·Z-0794-2025·Announced 2025-01-08

Medline surgical procedure kits recalled for non-sterile components and endotoxin contamination

Medline is recalling 474,300 custom surgical procedure kits because they contain non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination. These components could pose infection risks during surgical procedures.

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 involving non-sterile surgical components with potential for endotoxin contamination—a high-risk hazard in surgical kits. No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet been reported, consistent with Score 3 criteria.

Plain-English summary

Medline Industries is recalling 474,300 custom surgical procedure kits across multiple product lines, including Craniotomy, Craniofacial, Cervical Spine, Lumbar, and other neuro and orthopedic spine surgery kits. The recall affects numerous Reference (REF) numbers and corresponding lot numbers distributed between 2019 and 2024.

The kits are being recalled because they contain non-sterile Codman Surgical Patties and Surgical Strips, which have the potential for endotoxin contamination. Non-sterile surgical components used during procedures pose a risk of infection and adverse patient outcomes.

The affected kits have been distributed worldwide, including throughout the United States, United Arab Emirates, and Canada. Healthcare facilities and surgical centers that received these products are asked to identify affected inventory using the detailed lot numbers and reference numbers specified in the official recall notice.

The recalled product

Product
Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V; 2) CRANIOFACIAL CDS, REF CDS780102K; 3) CRANIOFACIAL CDS, REF CDS780102L; 4) CRANIOFACIAL CDS, REF CDS780102M; 5) CRANIOTOMY CDS-LF, REF CDS780105K; 6) CRANIOTOMY CDS-LF, REF CDS780105L; 7) CRANIO
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Supplies / Surgical Kits
Hazard
Affected units
474,300

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)

  • UDI/DI 10193489587418 (EA) 40193489587419 (CS)
  • Lot number 19BLA484
  • REF CDS780102K
  • UDI/DI 10889942714506 (EA) 40889942714507 (CS)
  • Lot number 19DBN638
  • Lot number 19EBN450
  • Lot number 19FBN031
  • Lot number 19JBE273
  • Lot number 19JBI710
  • Lot number 19KBR616
  • Lot number 20BBQ409
  • Lot number 20CBP611
  • Lot number 20EBG877
  • Lot number 20EBS145
  • Lot number 20FBB178
  • Lot number 20FBR886
  • Lot number 20JBH667
  • Lot number 21BBJ070
  • Lot number 21DBH746
  • Lot number 21HBJ414

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 18 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 18 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

See all →

Same hazard · non sterile

See all →