The Recall Desk
HighFDA (Devices)·Z-0723-2025·Announced 2025-01-01

Medline surgical patties and strips recalled for endotoxin contamination

Medline surgical patties and strips used in certain procedure convenience kits were found to contain higher-than-expected endotoxin levels that may exceed safety specifications. The affected kits were distributed nationwide and in Canada.

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 risk-of-harm medical device recall with no reported illnesses or injuries. Endotoxin contamination of surgical devices poses a serious infection risk to patients undergoing procedures, meeting the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries is recalling specific lots of surgical patties and surgical strips used in custom procedure convenience kits due to higher-than-expected endotoxin levels found in the raw material. These products may contain out-of-specification endotoxin levels in the finished goods.

Endotoxin is a pyogenic substance produced by bacteria that can trigger serious infections and inflammatory responses if introduced into the body during surgical procedures. Surgical patties and strips are sterile devices used to absorb blood and other fluids during surgery. Endotoxin contamination of these devices poses a significant infection risk to patients undergoing procedures.

The recalled kits include multiple product variants such as Craniotomy, MVFF/FIBU, Neuro Pediatric, Spine Pack, and Lymphatic Bypass packs, with specific lot numbers identified for each SKU. These convenience kits were distributed throughout the United States and Canada.

The recalled product

Product
Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X; 2) MVFF/FIBU #54-RF, SKU DYNJ21927Q; 3) MVFF/FIBU #54-RF, SKU DYNJ21927S; 3) NEURO PEDIATRIC, SKU DYNJ61607A; 4) CRANIOTOMY PACK, SKU DYNJ66419C; 5) LYMPHATIC BYPASS PACK, SKU DYNJ69907;
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Instruments / Supplies
Hazard

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: CDS982719X
  • 10198459064531 (each)
  • 40198459064532 (case)
  • Lot Numbers: 24IBE288
  • UDI-DI: DYNJ21927Q
  • 10889942885534 (each)
  • 40889942885535 (case)
  • UDI-DI: DYNJ21927S
  • 10195327576233 (each)
  • 40195327576234 (case)
  • Lot Numbers: 24GBQ357 24GBK331 24FBF951 24CBV435 24BBN342 24ABW268
  • UDI-DI: DYNJ61607A
  • 10193489665734 (each)
  • 40193489665735 (case)
  • Lot Numbers: 22FLB055 22FLA458
  • UDI-DI: DYNJ66419C
  • 10198459059353 (each)
  • 40198459059354 (case)
  • Lot Numbers: 24IBG439
  • UDI-DI: DYNJ69907

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 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 10 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · endotoxin

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