Sklar Instruments recalls two sterile medical procedure kits due to packaging issues that may breach sterile barriers. Affected kits have specific model numbers and lot codes. Consumers should contact Sklar for details.
Reports of various packaging issues that may result in a breach of the sterile barrier.
Sklar Instruments is recalling two types of sterile medical procedure kits because their packaging might not stay sealed properly. This could lead to contamination during medical procedures if the sterile barrier is broken.
The packaging may breach the sterile barrier, allowing contaminants to enter the kit. This could cause infections during medical procedures if the sterile barrier is compromised.
Healthcare providers using these kits for gynecologic biopsies are most at risk. Patients using the kits under medical supervision may also be affected.
Check for model numbers 96-4134M or 96-4137M on the kit packaging. Lot codes SK-114 or SK-116 are also associated with these kits.
Reach out to Sklar Instruments directly for specific recall details and instructions.
The recall is due to potential packaging issues that could breach the sterile barrier, so they should not be used until the manufacturer provides instructions.
Model numbers 96-4134M and 96-4137M are affected, with lot codes SK-114 and SK-116 respectively.
Look for model numbers 96-4134M or 96-4137M and lot codes SK-114 or SK-116 on the packaging.
We’ve drafted a message you can send Sklar Instruments to request your refund or repair — edit it as you like.
Subject: Recall Z-0947-2025 — Sklar Instruments Sklar Instruments Hello, I own a Sklar Instruments that is covered by recall Z-0947-2025 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.