Reported Jan 22, 2025 · Ongoing
ECONO STERILE medical procedure kits labeled as
Sklar Instruments
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sklar Instruments · 1333 Lenape Rd · West Chester, PA · 19382-6816
Is this the product you have?
ECONO STERILE medical procedure kits labeled as
7 of 7 products
| # | Product as published |
|---|---|
| 1 | ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960 |
| 2 | ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-0961 |
| 3 | ECONO STERILE HEGAR DILATOR 7&8MM STRL CS25Model Number 96-0962 |
| 4 | ECONO STERILE HEGAR DILATOR 5&6MM STERL CS25Model Number 96-0963 |
| 5 | ECONO STERILE HEGAR DILATOR 3&4MM STERL CS25Model Number 96-0964 |
| 6 | ECONO STERILE HEGAR DILATOR 1&2MM STERL CS25Model Number 96-0965 |
| 7 | ECONO STERILE HANK DILATOR 5.5&6MM STRL CS25Model Number 96-0966; gynecological dilators |
- Lot codes and dates
7 of 7 products
Products covered by this recall # Barcodes Product as published 1 5064911147479696-0960, UDI/DI 50649111474796, Lot codes: FSS5 2 5064911147480296-0961, UDI/DI 50649111474802, Lot codes: FSS5 3 5064911147481996-0962, UDI/DI 50649111474819, Lot codes: FSS5 4 5064911147482696-0963, UDI/DI 50649111474826, Lot codes: FSS5 5 5064911147483396-0964, UDI/DI 50649111474833, Lot codes: FSS5 6 5064911147484096-0965, UDI/DI 50649111474840, Lot codes: FSS5 7 5064911147485796-0966, UDI/DI 50649111474857, Lot codes: SK-119. - Amount recalled
- 75 units
This recall covers 30 products
The agency filed one notice per product. You are reading one of them; the other 29 are below.
17 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Reports of various packaging issues that may result in a breach of the sterile barrier.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new packaged foods recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.