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
31 of 31 products
| Model / number | Product as published |
|---|---|
96-2352A | ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25 |
96-2353 | ECONO STERILE HALSEY NH SERR 5" STRL CS/25 |
96-2355A | ECONO STERILE OLSEN-HEGAR NH 5.5" STRL CS/25 |
96-2356A | ECONO STERILE OLSEN-HEGAR NH DEL 5.5 STER 25 |
96-2358A | ECONO STERILE OLSEN-HEGAR NH SMO 5.5 STER 25 |
96-2417 | ECONO STERILE WEBSTER NH SERR JAW5.25" CS/25 |
96-2580 | ECONO STERILE BAUMGARTNER NH 5.5" STER CS/50 |
96-2581 | ECONO STERILE BAUMGARTNER NH 5.5" STER CS/25 |
96-2581A | ECONO STERILE BAUMGARTNER NH 5.5" STER CS/25 |
96-2583 | ECONO STERILE DERF NH SERR 4 3/4" STERL CS25 |
96-2583A | ECONO STERILE DERF NH SERR 4 3/4" STERL CS25 |
96-2585 | ECONO STERILE HALSEY NH SMOOTH 5" STERL CS25 |
96-2585A | ECONO STERILE HALSEY NH SMOOTH 5" STERL CS25 |
96-2586 | ECONO STERILE WEBSTER NH SMO 5.25" STER CS50 |
96-2587 | ECONO STERILE WEBSTER NH SMO 5.25" STER CS25 |
96-2590 | ECONO STERILE CRILE-WOOD NH 6" STERILE CS/50 |
96-2591 | ECONO STERILE CRILE-WOOD NH 6" STERILE CS/25 |
96-2591A | ECONO STERILE CRILE-WOOD NH 6" STERILE CS/25 |
96-2594 | ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/50 |
96-2595 | ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/25 |
- Lot codes and dates
31 of 31 products
Products covered by this recall # Barcodes Product as published 1 5064911148815196-2352A, UDI/DI 50649111488151, Lot codes: HSI 2 5064911139799696-2353, UDI/DI 50649111397996, Lot codes: SK-130 3 5064911148814496-2355A, UDI/DI 50649111488144, Lot codes: HSI 4 5064911148813796-2356A, UDI/DI 50649111488137, Lot codes: HSI 5 5064911148816896-2358A, UDI/DI 50649111488168, Lot codes: HSI 6 5064911144027296-2417, UDI/DI 50649111440272, Lot codes: SK-130 7 5064911106269696-2580, UDI/DI 50649111062696, Lot codes: FSF12, FSF13, FSF17, FSF20, FSF22, FSF24, FSF26, FSS19 8 5064911106295596-2581, UDI/DI 50649111062955, Lot codes: FSF12, FSF17, FSF20, FSF22 9 5064911148779696-2581A, UDI/DI 50649111487796, Lot codes: SK-112 10 5064911106326696-2583, UDI/DI 50649111063266, Lot codes: SK-130 11 5064911148783396-2583A, UDI/DI 50649111487833, Lot codes: SK-112 12 5064911106354996-2585, UDI/DI 50649111063549, Lot codes: FSF12, FSF14, FSF21 13 5064911148789596-2585A, UDI/DI 50649111487895, Lot codes: SK-112 14 5064911106387796-2586, UDI/DI 50649111063877, Lot codes: SK-130 15 5064911106401096-2587, UDI/DI 50649111064010, Lot codes: SK-130, SK-131 16 5064911106457796-2590, UDI/DI 50649111064577, Lot codes: FSF12, FSF17, FSF22 17 5064911106479996-2591, UDI/DI 50649111064799, Lot codes: FSF12, FSF13, FSF20, FSF26 18 5064911148782696-2591A, UDI/DI 50649111487826, Lot codes: SK-112 19 5064911106543796-2594, UDI/DI 50649111065437, Lot codes: FSF7, FSF12, FSF16, FSF17, FSF18 20 5064911106564296-2595, UDI/DI 50649111065642, Lot codes: FSF5, FSF16, FSF18, FSF19, FSF20 - Amount recalled
- 41850 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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