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
8 of 8 products
| Model / number | Product as published |
|---|---|
96-2603 | ECONO STERILE GRAVES SPEC STRL SM BX/25 |
96-2605 | ECONO STERILE GRAVES SPEC STRL MD BX/25 |
96-2607 | ECONO STERILE GRAVES SPEC STRL LG BX/25 |
96-2615 | ECONO STERILE PEDERSON SPEC STERILE" SM BX/25, Model Number 96-2613; 5)ECONO STERILE PEDERSON SPEC STRL MD BX/25 |
96-2616 | ECONO STERILE PEDERSON SPEC STRL LG BX/50 |
96-2617 | ECONO STERILE PEDERSON SPEC STRL LG BX/25 |
96-3001 | ECONO STERILE GRAVES VAG SPEC STRL MD CS/50 |
96-3002 | ECONO STERILE GRAVES VAG SPEC STRL LG CS/50, ; speculum, gynecological |
- Lot codes and dates
9 of 9 products
Products covered by this recall # Barcodes Product as published 1 5064911106723396-2603, UDI/DI 50649111067233, Lot Codes: SK-119 2 5064911106762296-2605, UDI/DI 50649111067622, Lot Codes: SK-119 3 5064911106796796-2607, UDI/DI 50649111067967, Lot Codes: SK-119 4 5064911106896496-2613, UDI/DI 50649111068964, Lot Codes: SK-119 5 5064911106934396-2615, UDI/DI 50649111069343, Lot Codes: SK-119 6 5064911106957296-2616, UDI/DI 50649111069572, Lot Codes: SK-119 7 5064911106988696-2617, UDI/DI 50649111069886, Lot Codes: SK-119 8 5064911113388496-3001, UDI/DI 50649111133884, Lot Codes: SK-119 9 5064911113405896-3002, UDI/DI 50649111134058, Lot Codes: SK-119. - Amount recalled
- 475 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.
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