--- title: "ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG N... — FDA record Z-0954-2025 | Is It on Recall" description: "Reports of various packaging issues that may result in a breach of the sterile barrier." url: https://isitonrecall.com/recall/fda-device-z-0954-2025-econo-sterile-medical-procedure-kits-labeled-as-1-econo-sterile-olsen-heg-nh-smo-del-5-5ster25-model/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-235... — FDA record Z-0954-2025 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Dec 3, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A; 2) ECONO STERILE HALSEY NH SERR 5" STRL CS/25, Model Number 96-2353; 3) ECONO STERILE OLSEN-HEGAR NH 5.5" STRL CS/25, Model Number 96-2355A; 4) ECONO STERILE OLSEN-HEGAR NH DEL 5.5 STER 25, Model Number 96-2356A; 5) ECONO STERILE OLSEN-HEGAR NH SMO 5.5 STER 25, Model Number 96-2358A; 6) ECONO STERILE WEBSTER NH SERR JAW5.25" CS/25, Model Number 96-2417; 7) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/50, Model Number 96-2580; 8) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/25, Model Number 96-2581; 9) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/25, Model Number 96-2581A; 10) ECONO STERILE DERF NH SERR 4 3/4" STERL CS25, Model Number 96-2583; 11) ECONO STERILE DERF NH SERR 4 3/4" STERL CS25, Model Number 96-2583A; 12) ECONO STERILE HALSEY NH SMOOTH 5" STERL CS25, Model Number 96-2585; 13) ECONO STERILE HALSEY NH SMOOTH 5" STERL CS25, Model Number 96-2585A; 14) ECONO STERILE WEBSTER NH SMO 5.25" STER CS50, Model Number 96-2586; 15) ECONO STERILE WEBSTER NH SMO 5.25" STER CS25, Model Number 96-2587; 16) ECONO STERILE CRILE-WOOD NH 6" STERILE CS/50, Model Number 96-2590; 17) ECONO STERILE CRILE-WOOD NH 6" STERILE CS/25, Model Number 96-2591; 18) ECONO STERILE CRILE-WOOD NH 6" STERILE CS/25, Model Number 96-2591A; 19) ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/50, Model Number 96-2594; 20) ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/25, Model Number 96-2595; 21) ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/25, Model Number 96-2595A; 22) ECONO STERILE MAYO-HEGAR NH 5" STERILE CS/25, Model Number 96-2599; 23) ECONO STERILE WEBSTER NH SMO 5 1/4 STRL C100, Model Number 96-2659; 24) ECONO STERILE MAYO-HEGAR NH 7" STERILE CS/50, Model Number 96-2710; 25) ECONO STERILE MAYO-HEGAR NH 8" STERL CS25, Model Number 96-2711; 26) ECONO STERILE MAYO-HEGAR NH 8" STERL CS25, Model Number 96-2711A; 27) ECONO STERILE MAYO-HEGAR NH 8" STERILE CS/50, Model Number 96-2712; 28) ECONO STERILE WEBSTER NH FINE 5.25" STER 25, Model Number 96-2740A; 29) ECONO STERILE WEBSTER NH X-FIN LG 5" STER 25, Model Number 96-2741A; 30) ECONO STERILE WEBSTER NH X-FN SMO 5" STER 25, Model Number 96-2742A; 31) ECONO STERILE HALSEY NH SERR TC 5" STER CS25, Model Number 96-2745A; general orthopedic surgery - **Reason**: Reports of various packaging issues that may result in a breach of the sterile barrier. - **Classification**: Class II - **Recalling firm**: Sklar Instruments - **Quantity**: 41850 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0954-2025 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0954-2025%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | 1) 96-2352A, UDI/DI 50649111488151, Lot codes: HSI; 2) 96-2353, UDI/DI 50649111397996, Lot codes: SK-130; 3) 96-2355A, UDI/DI 50649111488144, Lot codes: HSI; 4) 96-2356A, UDI/DI 50649111488137, Lot codes: HSI; 5) 96-2358A, UDI/DI 50649111488168, Lot codes: HSI; 6) 96-2417, UDI/DI 50649111440272, Lot codes: SK-130; 7) 96-2580, UDI/DI 50649111062696, Lot codes: FSF12, FSF13, FSF17, FSF20, FSF22, FSF24, FSF26, FSS19; 8) 96-2581, UDI/DI 50649111062955, Lot codes: FSF12, FSF17, FSF20, FSF22; 9) 96-2581A, UDI/DI 50649111487796, Lot codes: SK-112; 10) 96-2583, UDI/DI 50649111063266, Lot codes: SK-130; 11) 96-2583A, UDI/DI 50649111487833, Lot codes: SK-112; 12) 96-2585, UDI/DI 50649111063549, Lot codes: FSF12, FSF14, FSF21; 13) 96-2585A, UDI/DI 50649111487895, Lot codes: SK-112; 14) 96-2586, UDI/DI 50649111063877, Lot codes: SK-130; 15) 96-2587, UDI/DI 50649111064010, Lot codes: SK-130, SK-131; 16) 96-2590, UDI/DI 50649111064577, Lot codes: FSF12, FSF17, FSF22; 17) 96-2591, UDI/DI 50649111064799, Lot codes: FSF12, FSF13, FSF20, FSF26; 18) 96-2591A, UDI/DI 50649111487826, Lot codes: SK-112; 19) 96-2594, UDI/DI 50649111065437, Lot codes: FSF7, FSF12, FSF16, FSF17, FSF18; 20) 96-2595, UDI/DI 50649111065642, Lot codes: FSF5, FSF16, FSF18, FSF19, FSF20; 21) 96-2595A, UDI/DI 50649111488052, Lot codes: SK-112; 22) 96-2599, UDI/DI 50649111066342, Lot codes: FSF6, FSF21; 23) 96-2659, UDI/DI 50649111077669, Lot codes: SK-130; 24) 96-2710, UDI/DI 50649111085664, Lot codes: FSF13; 25) 96-2711, UDI/DI 50649111478886, Lot codes: FSF10; 26) 96-2711A, UDI/DI 50649111488069, Lot codes: SK-112; 27) 96-2712, UDI/DI 50649111085916, Lot codes: FSF10; 28) 96-2740A, UDI/DI 50649111488274, Lot codes: SK-112; 29) 96-2741A, UDI/DI 50649111488281, Lot codes: SK-112; 30) 96-2742A, UDI/DI 50649111488298, Lot codes: SK-112; 31) 96-2745A, UDI/DI 50649111487949, Lot codes: 60440. | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Domestic: Nationwide Distribution States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Jan 22, 2025 - **Recall initiation date**: Dec 3, 2024 - **Center classification date**: Jan 16, 2025 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0954-2025%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Sklar Instruments records](https://isitonrecall.com/brand/sklar-instruments/)