FDA Device recall Z-3111-2024
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO BRONCH PACK, Pack Number DYKE1355
- FDA Device
- Class II
- ongoing
- Published 2024-09-18
On 2024-09-18 the FDA classified a Class II recall of Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO BRONCH PACK, Pack Number DYKE1355 by Medline Industries Northfield, citing due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the pot….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3111-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-27 |
| Published | 2024-09-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO BRONCH PACK, Pack Number DYKE1355; b) ENDO BASIC KIT, Pack Number DYKE1356; c) ENDOSCOPY KIT, Pack Number DYKE1771C
Reason
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Identifiers
| code_info | a) DYKE1355: UDI/DI case 40889942274193, UDI/DI each 10889942274192; Lot Numbers: 23LBB043, 24BBJ327, 24CBS751; b) DY…a) DYKE1355: UDI/DI case 40889942274193, UDI/DI each 10889942274192; Lot Numbers: 23LBB043, 24BBJ327, 24CBS751; b) DYKE1356: UDI/DI case 40889942274186, UDI/DI each 10889942274185; Lot Numbers: 23LBD062, 24ABA646, 24BBJ328, 24CBG449, 24DBE106, 24EBG238; c) DYKE1771C: UDI/DI case 40195327331994, UDI/DI each 10195327331993; Lot Numbers: 24ABX292 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3111-2024%22
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