Medline Convenience Kits recallZ-2543-2026 · Medline Industries, LP · initiated May 21, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
FDA root cause category: Nonconforming Material/Component
What the company is doing
An URGENT MEDICAL DEVICE RECALL notification letter dated 5/21/26 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-082-FGX2 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].
Recall details
- Recall number
- Z-2543-2026
- Status
- Open, Classified
- Initiated by the company
- May 21, 2026
- Posted by the FDA
- Jun 29, 2026
- Recalling firm
- Medline Industries, LP
- Quantity
- 250 kits
- Product code
- LRS
- Distribution
- US Nationwide distribution.
Product description
Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350
Code information (models, lots, serial numbers)
1) ART890B, UDI-DI: 10653160360834(each), 00653160360837(case), Lot Number: 2025102390; 2) IVS3350, UDI-DI: 10653160313045(each), 00653160313048(case), Lot Number: 2025102490
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Centurion IVS3350Centurion Medical Products Corporation · I.V. start kit2 recalls0 reports
- MEDLINE ART890BMedline Industries, Inc. · I.V. start kit2 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99162).
- Z-2533-2026 · Open, ClassifiedMedline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number: ART1145; 2) Universal Central/Art Line Insertion Kit, Model Number: ART155A; 3) ARTERIAL LINE INSERTI…
- Z-2534-2026 · Open, ClassifiedMedline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L; 2) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1317; 3) CONTINUOUS EPIDURAL TRAY, Model Number: …
- Z-2535-2026 · Open, ClassifiedMedline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590
- Z-2536-2026 · Open, ClassifiedMedline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995; 2) TRIPLE LUMEN CENTRAL LINE BUNDLE, Model Number: ECVC2625; 3) INTROFLEX 6F, 1L, TB, US…
- Z-2537-2026 · Open, ClassifiedMedline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF; 2) PAIN1470A, Model Number: CONT. 20G EPI MRI COMPATIBLE; 3) TVS4000L, Model Number: TVS4000 …
- Z-2538-2026 · Open, ClassifiedMedline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C; 2) STD, INTRO-FLEX INTRODUCER 9F, C, Model Number: I505BF9C
- Z-2539-2026 · Open, ClassifiedMedline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; 2) BREAST BIOPSY PACK, Model Number: PHS234706I
- Z-2540-2026 · Open, ClassifiedMedline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710
- Z-2541-2026 · Open, ClassifiedMedline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 2) NO CATH CENTRAL LINE KIT, Model Number: CVI4880B; 3) 20G x 6" ARTERIAL CATHETER KIT, Model Numbe…
- Z-2542-2026 · Open, ClassifiedMedline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 3) CONTRACEPTIVE IMPLANT INSERTION KIT, Model Number: MNS97…
- Z-2544-2026 · Open, ClassifiedMedline Convenience Kits: 1) LUMBAR PUNCTURE CHOICE, Model Number: DYNDH1215
- Z-2545-2026 · Open, ClassifiedMedline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1699A
- Z-2546-2026 · Open, ClassifiedMedline Convenience Kits: 1) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: CIT6780; 2) CIRCUMCISION TRAY W/1.1CM CIRCLAMP, Model Number: CIT3225A; 3) CIRCUMCISION TRAY, Model Nu…
- Z-2547-2026 · Open, ClassifiedMedline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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