Medline recalls SUT13710 suturing kits with Lidocaine Ampules due to FDA quality concerns from Huons Co. Ltd. manufacturing inspection. Affected kits have specific model and lot numbers.
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.
Medline is recalling its SUT13710 suturing kits that contain Huons Lidocaine HCL Injection. The recall is due to quality issues found during an FDA inspection of Huons Co. Ltd.'s manufacturing site. This could affect medical use safety.
The recall is triggered by quality issues identified during an FDA inspection of Huons Co. Ltd.'s manufacturing facility. These issues could potentially impact the safety and effectiveness of the Lidocaine Ampules in medical use.
Healthcare professionals using Medline SUT13710 suturing kits with the specified model and lot numbers are most at risk. Patients receiving injections from these kits may also be affected.
Check for model number SUT13710 on the kit. Lot numbers 2025102290 are also associated with this recall. The kits may have a unique identifier code 00653160148527 per unit.
Identify the model number SUT13710 and lot number 2025102290 on the kit to confirm if it is affected.
The FDA identified quality issues during an inspection of Huons Co. Ltd.'s manufacturing site, which could affect the safety of the Lidocaine Ampules.
Check the model number and lot number on the kit to see if it is affected. If it matches the recall criteria, stop using it and contact Medline for further instructions.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2540-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2540-2026 from Medline. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.