Agency classClass IIOur severity:High FDA (Devices)·Z-2480-2026·Announced 2026-06-24

Medline 15 Fr urethral catheterization trays fail performance specifications

Medline Urethral Catheterization Trays with red rubber latex catheter, 15 Fr, are being recalled because samples did not meet performance specifications. 8,327,756 units are affected.

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 where a catheter connector can detach in use and dimensions fall out of specification, a risk of harm with no injuries reported.

Plain-English summary

Medline Urethral Catheterization Trays, red rubber latex, 15 Fr, product numbers DYNC1816 and DYND10350, are being recalled. The action covers 8,327,756 units.

During an internal review, Medline identified that representative samples did not meet applicable performance specifications. According to the firm, the identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. The FDA classified the action as Class II.

Affected product is UDI/DI 10080196990627 for the each and 40080196990628 for the case for DYNC1816, with the DYND10350 codes listed in the recall notice. Distribution was worldwide, including nationwide in the United States and to the United Arab Emirates, Barbados, Bermuda, the Bahamas, Canada, Cyprus, Guam, the Netherlands, Panama, Qatar, Saudi Arabia and the US Virgin Islands.

Facilities should identify affected stock using the product numbers and UDI codes in the recall notice, quarantine it, and follow the instructions issued by Medline.

The recalled product

Product: MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYNC1816, 15 Fr; 2. DYND10350, 15 Fr.
Manufacturer: Medline Industries, LP
Category: Medical Device — Urinary catheter tray
Hazard: out-of-specification
catheter-defect
connector-detachment
class-ii
Affected units: 8,327,756

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 (6)

1. DYNC1816
UDI/DI 10080196990627 (each)
40080196990628 (case)
2. DYND10350
UDI/DI 10080196028665 (each)
40080196028666 (case). ALL LOTS

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 30 recalled by Medline Industries, LP 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 30 products in this recall →

Same manufacturer · Medline Industries, LP

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