Agency classClass IIOur severity:High FDA (Devices)·Z-0931-2023·Announced 2023-01-18

Stradis Healthcare Foley Catheter Insertion Tray Recalled for Sterility Breach Risk

Stradis Healthcare is recalling Foley Catheter Insertion Trays due to potential pinhole leaks in the outer bag that could compromise sterility. The recall affects 920 units distributed across multiple US states.

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 FDA Class II recall involves risk-of-harm for patients—sterility compromise in urinary catheter trays could lead to infection. No illnesses or injuries have been reported, supporting classification as High severity for a risk-of-harm product without documented injury.

Plain-English summary

Stradis Healthcare is recalling its Foley Catheter Insertion Tray with preconnected bag and catheter (sterile) due to a potential defect in the outer packaging. A total of 920 units are affected by this recall.

The outer bag may develop pinhole leaks near the seal, which could result in a breach of the kit's sterility. If the sterile barrier is compromised, the catheter and other kit components may be exposed to contamination, potentially affecting patient safety.

The affected products include Assembly Number 33066 and Assembly Number 33068 with associated lot numbers. The recalled units were distributed nationwide in Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas, and Washington. Healthcare facilities should identify affected inventory using the assembly and lot numbers.

Healthcare providers who have received these units should stop use immediately and return them to Stradis Healthcare. Patients or healthcare facilities with questions should contact Stradis Healthcare or their medical provider.

The recalled product

Product: Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
Manufacturer: Stradis Healthcare
Category: Medical Device — Urinary Catheter Tray
Hazard: sterility-compromise
packaging-defect
pinhole-leak
Affected units: 920

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 (10)

a. Assembly Number 33066
UDI-DI: M752330661
Lot Numbers: 222782334
222519530
222438660
b. Assembly Number 33068
UDI-DI: M752330681
Lot Numbers: 222145412
220551558
222508466

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Part of a larger recall action

This product is one of 18 recalled by Stradis Healthcare 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 · Stradis Healthcare

See all →

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HCT 6 CC Syringe Kits recalled for potential sterility breach from packaging leaks
FDA (Devices) · 2023-01-18
High
Fluid Filter Transfer Kit Recalled Over Potential Sterility Breaches
FDA (Devices) · 2023-01-18
High
PHS Lacertaion Tray Sterile Kit Recall Due to Seal Leakage Risk
FDA (Devices) · 2023-01-18

Same hazard · sterility compromise