Medline recalls two biopsy kits due to quality problems with Lidocaine Ampules identified during FDA inspection. Affected kits include specific model numbers and lot dates. Consumers should contact Medline for details.
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 two types of biopsy kits because the Lidocaine Ampules they contain were found to have quality issues during an FDA inspection. This could affect medical procedures if the ampules are used improperly.
The recall is based on FDA findings that the Lidocaine Ampules had quality issues during manufacturing. This could lead to improper medication delivery if the ampules are not safe for use.
Medical professionals using the recalled biopsy kits are most at risk. Patients receiving procedures with these kits may also be affected.
Check for model numbers DYNDH1068 on the imaging biopsy tray or PHS234706I on the breast biopsy pack. Lot numbers 2025101090 or 25JLB029 indicate affected items.
Reach out to Medline Industries for specific instructions on how to handle the recalled kits.
The FDA identified quality issues with the Lidocaine Ampules during a manufacturing inspection, which could affect safe use.
The imaging biopsy tray model DYNDH1068 and breast biopsy pack model PHS234706I are affected.
Check for lot numbers 2025101090 or 25JLB029 on the kits.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2539-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2539-2026 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.
