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Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, ...

FDA Device Recall #Z-3114-2024 — Class II — June 27, 2024

Recall Summary

Recall Number Z-3114-2024
Classification Class II — Moderate risk
Date Initiated June 27, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm MEDLINE INDUSTRIES, LP - Northfield
Location Northfield, IL
Product Type Devices
Quantity 3117 units

Product Description

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 for Recall

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.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

Lot / Code Information

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, 24CBD863; j) DYNJ908750D: UDI/DI case 40195327549214, UDI/DI each10195327549213, Lot Numbers: 24FBC284; k) DYNJ909731: UDI/DI case 40195327464524, UDI/DI each10195327464523, Lot Numbers: 24ABU492; l) DYNJ909735: UDI/DI case 40195327464685, UDI/DI each10195327464684, Lot Numbers: 23LBH989, 24ABV099, 24CBG700; m) DYNJ909945: UDI/DI case 40195327512669, UDI/DI each10195327512668, Lot Numbers: 24ABV895; n) DYNJ909945A: UDI/DI case 40195327615803, UDI/DI each10195327615802, Lot Numbers: 24DBA530; o) DYNJ910289: UDI/DI case 40195327618675, UDI/DI each10195327618674, Lot Numbers: 24CBC847; p) DYNJ910289H: UDI/DI case 40198459012489, UDI/DI each10198459012488, Lot Numbers: 24CBC847; q) DYNJC9311M: UDI/DI case 40198459012489, UDI/DI each10198459012488, Lot Numbers: 24FDA111; r) P906877: UDI/DI case 40889942002581, UDI/DI each10889942002580, Lot Numbers: 24FDA021

Other Recalls from MEDLINE INDUSTRIES, LP - Northfield

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Z-2567-2025 Class I Medline medical convenience kits labeled as: ... Jul 25, 2025
Z-2566-2025 Class I Medline medical convenience kits labeled as: ... Jul 25, 2025
Z-2479-2025 Class II Medline Kits containing BD SureStep Foley Tray ... Jul 23, 2025
Z-2460-2025 Class I Medline ReNewal Reprocessed St. Jude Medical Re... Jul 14, 2025
Z-2452-2025 Class II The Medline General Surgery Tray is customized ... Jul 8, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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