Spectra Medical Devices recalls lidocaine injection ampules due to lack of sterility assurance. Affected lots from 2023-2028 may cause infections if used improperly.
Lack of Assurance of Sterility
Spectra Medical Devices is recalling lidocaine injection ampules that may not be sterile, which could lead to infections if used. This recall affects specific lots manufactured in South Korea with expiration dates through 2028.
The injection ampules may not be sterile, meaning they could introduce harmful bacteria into the body during medical procedures. This risk is specific to the recalled lots and does not affect all lidocaine products.
Healthcare professionals and patients who have received the recalled lidocaine injection ampules. Those using the product for medical procedures are most at risk.
Check for the lot numbers AE4013 (expiring 1/31/2027), AE5032 & AE5039 (expiring 3/31/2028), or AE5104 (expiring 8/31/2028) on the ampule packaging. The product is distributed by Spectra Medical Devices, LLC in South Korea.
Look for the lot numbers AE4013, AE5032, AE5039, or AE5104 on the ampule packaging.
The ampules may not be sterile, which could lead to infections if used in medical procedures.
Check the lot numbers on the packaging: AE4013 (expiring 1/31/2027), AE5032 & AE5039 (expiring 3/31/2028), or AE5104 (expiring 8/31/2028).
The recall does not require immediate discontinuation; check the lot number to determine if your product is affected.
We’ve drafted a message you can send Spectra Medical Devices to request your refund or repair — edit it as you like.
Subject: Recall D-0554-2026 — Spectra Medical Devices Spectra Medical Devices Hello, I own a Spectra Medical Devices that is covered by recall D-0554-2026 from Spectra Medical Devices. 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.
