FDA Device recall Z-3114-2024
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1092B
- 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 KIT, Pack Number DYKE1092B 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-3114-2024 |
| 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 KIT, Pack Number DYKE1092B; b) VIDEO BRONCHOSCOPY TRAY, Pack Number DYKE1666; c) SUCTION CANISTER KIT, Pack Number DYKM2196; d) SUCTION CANISTER KIT, Pack Number DYKM2196H; e) BRONCH LAB PACK-LF, Pack Number DYNJ24810B; f) THORACIC, Pack Number DYNJ907991F; g) RECTAL, Pack Number DYNJ908108A; h) ROBOTIC, Pack Number DYNJ908109C; i) CERVICAL, Pack Number DYNJ908748D; j) LAMI, Pack Number DYNJ908750D; k) MERCY TIFFIN BASIC-LF, Pack Number DYNJ909731; l) MERCY TIFFIN LITHOTOMY, Pack Number DYNJ909735; m) BASIC GENERAL SET UP, Pack Number DYNJ909945; n) BASIC GENERAL SET UP, Pack Number DYNJ909945A; o) AMB OCULOPLASTICS MUSC, Pack Number DYNJ910289; p) AMB OCULOPLASTICS MUSC, Pack Number DYNJ910289H; q) MTHZ TOTAL HIP, Pack Number DYNJC9311M; r) BRONCH KIT, Pack Number P906877
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) DYKE1092B: UDI/DI case 40889942777366, UDI/DI each10889942777365, Lot Numbers: 24BBK418, 24DBH210; b) DYKE1666: U…a) DYKE1092B: UDI/DI case 40889942777366, UDI/DI each10889942777365, Lot Numbers: 24BBK418, 24DBH210; b) DYKE1666: UDI/DI case 40193489708487, UDI/DI each10193489708486, Lot Numbers: 24ADB503, 24CDA282, 24CDB279, 24DDB221, 24EDA406; c) DYKM2196: UDI/DI case 40195327236916, UDI/DI each10195327236915, Lot Numbers: 23LBF762, 24BBB541, 24CBI973, 24DBH448; d) DYKM2196H: UDI/DI case 40195327236916, UDI/DI each10195327236915, Lot Numbers: 23LBF762, 24BBB541, 24CBI973, 24DBH448; e) DYNJ24810B: UDI/DI case 40889942440611, UDI/DI each10889942440610, Lot Numbers: 24CBE214; f) DYNJ907991F: UDI/DI case 40195327641468, UDI/DI each10195327641467, Lot Numbers: 24DLA042, 24DLA594; g) DYNJ908108A: UDI/DI case 40195327507153, UDI/DI each10195327507152, Lot Numbers: 24BBK532; h) DYNJ908109C: UDI/DI case 40195327507238, UDI/DI each10195327507237, Lot Numbers: 23LBT867, 24BBA187, 24DBI723, 24FBA058; i) DYNJ908748D: UDI/DI case 40195327549207, UDI/DI each10195327549206, Lot Numbers: 23LBE394, |
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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-3114-2024%22
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