Sklar Instruments recalls ECONO STERILE gynecological dilators with model numbers 96-0960 to 96-0966 due to packaging issues that may breach sterile barriers, risking infection during medical procedures.
Reports of various packaging issues that may result in a breach of the sterile barrier.
Sklar Instruments is recalling seven specific gynecological dilator kits because their packaging might be damaged, which could break the sterile barrier and lead to infections during medical procedures. This is serious because medical procedures require sterile conditions to prevent infections.
The packaging may have defects that cause the sterile barrier to be breached. If the barrier is broken, medical procedures could become contaminated, increasing the risk of infection for patients.
Medical professionals and patients using the recalled ECONO STERILE gynecological dilators for procedures. Those who have the specific model numbers and lot codes listed are most at risk.
Check for the model numbers 96-0960 to 96-0966 on the packaging. The lot codes for these items are either FSS5 or SK-119. These dilators are used for gynecological procedures.
Inspect the packaging for signs of damage that might compromise the sterile barrier.
Reach out to Sklar Instruments for guidance on whether the item is affected and what to do next.
Sklar Instruments reports that the packaging of these gynecological dilators may have defects that could breach the sterile barrier, increasing infection risk during medical procedures.
The affected models are ECONO STERILE HEGAR DILATORS with model numbers 96-0960 to 96-0966, including specific lot codes FSS5 and SK-119.
The recall does not require immediate stop use; however, you should check the packaging for damage and contact Sklar Instruments for advice if you have the affected models.
We’ve drafted a message you can send Sklar Instruments to request your refund or repair — edit it as you like.
Subject: Recall Z-0946-2025 — Sklar Instruments Sklar Instruments Hello, I own a Sklar Instruments that is covered by recall Z-0946-2025 from Sklar Instruments. 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.
