Agency classClass IIOur severity:High FDA (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.

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: 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…
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Surgical Procedure Kits
Hazard: endotoxin-contamination
non-sterile
Affected units: 1,402

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.

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 →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · endotoxin contamination