The Recall Desk
HighFDA (Devices)·Z-3118-2024·Announced 2024-09-18

Medline semi-rigid suction liners recalled for potential loss of suction

Medline Industries recalls MTHZ GYN LAPAROSCOPY convenience kits with semi-rigid suction liners due to potential loss of suction during intermittent use. Affected products were manufactured between September and November 2023.

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 is a Class II medical device recall for surgical suction equipment with reported adverse events indicating potential loss of suction during intermittent use. While no injuries or hospitalizations are explicitly reported in the source, loss of suction in surgical equipment represents a risk-of-harm scenario.

Plain-English summary

Medline Industries is recalling semi-rigid suction liners used in gynecological laparoscopy convenience kits. The affected products are MTHZ GYN LAPAROSCOPY kits with Pack Number DYNJ909739, specifically lot numbers 24BBL055 and 24CBR861, manufactured between September and November 2023. A total of 55 units have been distributed worldwide, including in the United States, Canada, and Panama.

The recall was issued due to reported adverse events indicating potential loss of suction or low suction during intermittent suction use. Users of the affected products should discontinue use and contact Medline Industries for replacement or return instructions.

The recalled product

Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: MTHZ GYN LAPAROSCOPY, Pack Number DYNJ909739
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • suction-failure

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 (4)

  • DYNJ909739: UDI/DI case 40195327464692
  • UDI/DI each 10195327464691
  • Lot Numbers: 24BBL055
  • 24CBR861

Distribution

Distributed nationwide across the United States.