Agency classClass IIOur severity:High FDA (Devices)·Z-0718-2025·Announced 2025-01-01

Surgical patties and strips recalled due to endotoxin contamination

Medline Industries is recalling FESS-MB PACK-LF Convenience kits containing surgical patties and strips due to higher-than-expected endotoxin levels in raw materials, resulting in out-of-specification finished products.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 medical device recall involving endotoxin contamination in sterile surgical supplies with out-of-specification levels in finished goods. The source explicitly states no illnesses or injuries have been reported, making this a high-risk product where injury has not yet been reported, which qualifies as High severity per the rubric.

Plain-English summary

Medline Industries, LP is recalling Codman Surgical Patties and Strips packaged in FESS-MB PACK-LF Convenience kits (SKU DYNJ0888159I, Lot 23HMB316) due to endotoxin contamination. The kits are convenience packages used for various surgical procedures. Testing found higher-than-expected levels of endotoxin in the raw materials used to manufacture these sterile products, resulting in the finished surgical patties and strips containing out-of-specification endotoxin levels. Endotoxin is a substance present in certain bacteria that is of particular concern in sterile medical devices.

The affected convenience kits were distributed nationwide in the United States and to Canada, totaling approximately 36 kits. This is a Class II recall.

No illnesses or injuries have been reported to date in connection with this contamination.

The recalled product

Product: FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures..
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Surgical Supplies
Hazard: endotoxin
Affected units: 36

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 (3)

UDI-DI: 10195327050146(each)
40195327050147(case)
Lot Number: 23HMB316

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 →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · endotoxin