Agency classClass IIOur severity:High FDA (Devices)·Z-1088-2023·Announced 2023-02-15

Medline Sterile Surgical Trays Recalled Due to Blade Puncture Risk

Medline Industries recalls sterile surgical procedural trays because sterile blades within the kits may puncture the outer foil packaging, potentially compromising sterility. No injuries or illnesses have been reported.

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 medical device recall involving sterile surgical trays. The hazard—sterile blades potentially puncturing the outer foil packaging—creates risk of compromised sterility and possible post-operative infection in invasive surgical procedures. No illnesses or injuries have been reported, meeting the criterion for High severity as a risk-of-harm product without reported injury.

Plain-English summary

Medline Industries, LP is recalling multiple models of sterile procedural trays used in neurosurgical and other surgical procedures. The affected products include numerous tray variants such as AV SHUNT CDS, ZALE V-P SHUNT CDS, NEURO CDS-LF, and many others.

The recall is due to a potential safety issue: sterile blades within the kits may puncture the outer foil layer of the sterile packaging. If the packaging is compromised, the sterility of the contents cannot be assured.

The affected trays have been distributed worldwide, including throughout the United States and internationally to Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates. The recall affects 6,782 cases containing 15,253 units. No injuries or illnesses related to this issue have been reported.

Healthcare facilities and medical professionals who have received these products should discontinue use immediately and contact Medline Industries for instructions on return or replacement.

The recalled product

Product: Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ZALE V-P SHUNT CDS c. NEURO CDS-LF d. MAJOR NEURO e. NEURO PACK-LF f. CUSTOM NEURO PACK-LF g. NEURO PACK-LF h. NEURO PACK-LF i. NEURO PACK-LF j. NEURO PACK-LF k. NEURO/LAMINECTOMY BASIN PK-LF…
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Surgical Trays / Neurosurgical
Hazard: puncture
contamination-risk

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)

a. AV SHUNT CDS
Item Number: CDS983098D
Case UDI/GTIN: 40195327191307
Unit UDI/GTIN: 10195327191306
Lot Number: 22IBD957
b. ZALE V-P SHUNT CDS
Item Number: CDS983186J
Case UDI/GTIN: 40195327105625
Unit UDI/GTIN: 10195327105624
Lot Number: 22IBT194
c. NEURO CDS-LF
Item Number: CDS985289
Case UDI/GTIN: 40888277050502
Unit UDI/GTIN: 10888277050501
Lot Number: 22JBH363
22IBF823
22IBD861
d. MAJOR NEURO
Item Number: CDS985548N
Case UDI/GTIN: 40195327033256

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 38 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 38 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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