Sklar ECONO STERILE medical kits: Packaging issues risk sterile barrier breach

Take action

Contact the company & request your remedy

Recalling firmSklar Instruments1333 Lenape Rd · West Chester, PA 19382-6816

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Sklar Instruments is recalling medical procedure kits that may have packaging issues causing sterile barriers to breach. This could lead to infections during gynecological procedures if the kits are used without proper sterility.

Why it’s dangerous

The packaging may not seal properly, allowing contamination. This could compromise the sterile environment needed for medical procedures, increasing infection risk.

Who’s affected

Healthcare providers using these kits for gynecological procedures are most at risk. Patients undergoing such procedures could be affected if the kits are used without proper sterility.

How to tell if you have this one

Check for model number 96-2478 and lot code SK-121 on the packaging. These kits are labeled as ECONO STERILE SIMS UTERINE SND GRD 13"STER25.

Brand
Sklar Instruments
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Packaging
Look for model number 96-2478 and lot code SK-121 on the packaging.

✎ GovInfoNow

Questions people ask

Why is this recall happening?

The recall is due to reports of packaging issues that may result in a breach of the sterile barrier.

What is the risk of using these kits?

If the sterile barrier is breached, it could lead to infections during gynecological procedures.

Is there a remedy for this recall?

The recall record does not specify any remedy.

Take action

Contact Sklar Instruments

We’ve drafted a message you can send Sklar Instruments to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0928-2025 — Sklar Instruments Sklar Instruments

Hello,

I own a Sklar Instruments that is covered by recall Z-0928-2025 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.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

Where this comes from

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.

Official source: FDA Recall #Z-0928-2025 (December 3, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0928-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478

Lower-risk recall