The Recall Desk
HighFDA (Devices)·Z-3109-2024·Announced 2024-09-18

Medline Semi-Rigid Suction Liners Recalled for Potential Loss of Suction

Medline Industries is recalling 407 units of semi-rigid suction liners manufactured between September and November 2023 due to potential loss of suction during intermittent use.

What this means for you

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 a medical device with a functional hazard (potential loss of suction) that could affect critical clinical procedures. While specific injuries or hospitalizations are not detailed in the source, the defect in a device essential to surgical suctioning represents a risk-of-harm product.

Plain-English summary

Medline Industries, LP is recalling 407 units of semi-rigid suction liners across six product lines used in surgical and clinical settings. The affected products are: Baptist Floyd Bronchoscopy (Pack Number DYKE1456D), ENT Minor (Pack Number DYNJ908099B), Head & Neck (Pack Number DYNJ908101B), Nasal FESS (Pack Number DYNJ908105B), Nasal-LF (Pack Number DYNJ908429), and Mastopexy-Cannova (Pack Number DYNJ909948). The liners were manufactured between September and November 2023.

The recall was initiated due to reported adverse events related to the potential loss of suction or low suction during intermittent suction use. This functional defect could impact device performance during clinical or surgical procedures.

The affected products were distributed worldwide, including across the United States, Canada, and Panama. Each product line has been assigned specific lot numbers to facilitate identification of affected units.

The recalled product

Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) BAPTIST FLOYD BRONCHOSCOPY, Pack Number DYKE1456D; b) ENT MINOR, Pack Number DYNJ908099B; c) HEAD & NECK, Pack Number DYNJ908101B; d) NASAL FESS, Pack Number DYNJ908105B; e) NASAL-LF, Pa
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Suction Equipment
Hazard
Affected units
407

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) DYKE1456D: UDI/DI case 40195327639939
  • UDI/DI each 10195327639938
  • Lot Numbers: 24CBK289
  • 24BBK989
  • b) DYNJ908099B: UDI/DI case 40195327507085
  • UDI/DI each 10195327507084
  • Lot Numbers: 24DBI371
  • 24BBA188
  • c) DYNJ908101B: UDI/DI case 40195327507092
  • UDI/DI each 10195327507091
  • Lot Numbers: 24CBE408
  • 24BBA260
  • 24ABB112
  • d) DYNJ908105B: UDI/DI case 40195327507122
  • UDI/DI each 10195327507121
  • Lot Numbers: 24ABV362
  • e) DYNJ908429: UDI/DI case 40195327078820
  • UDI/DI each 10195327078829
  • Lot Numbers: 24CBB310
  • 23LBV007

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 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 17 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

See all →

Same hazard · loss of suction

See all →