CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report
Econo Sterile medical procedure kits labeled as recalled
Sklar Instruments is recalling Econo Sterile medical procedure kits labeled as: Econo Sterile Olsen-heg NH Smo Del, distributed nationwide in the US. The recall was initiated on 3 Dec 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0954-2025
- FDA event ID
- 95946
- Recalling firm
- Sklar Instruments, West Chester, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Dec 2024
- FDA classified
- 16 Jan 2025
- Reported
- 22 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Hip & Knee Implants
Timeline
| 3 Dec 2024 | Recall initiated by company | |
| 16 Jan 2025 | Classified by FDA | +44 days |
| 22 Jan 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Reports of various packaging issues that may result in a breach of the sterile barrier.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
Domestic: Nationwide Distribution
Questions about this recall
Why was it recalled?
Reports of various packaging issues that may result in a breach of the sterile barrier.
Which lots are affected?
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.
Where was it sold?
Domestic: Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
29 other products · FDA event 95946This product is part of a recall event; the main page for the event is Econo Sterile medical procedure kits labeled as recalled.
More recalls from Sklar Instruments
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Econo Sterile medical procedure kits labeled as recalled | Sklar Instruments | Sterility | Nationwide |
| Device | CLASS II | Econo Sterile medical procedure kits labeled as recalled | Sklar Instruments | Sterility | Nationwide |
| Device | CLASS II | Econo Sterile medical procedure kits labeled as recalled | Sklar Instruments | Sterility | Nationwide |
| Device | CLASS II | Econo Sterile medical procedure kits labeled as recalled | Sklar Instruments | Sterility | Nationwide |
| Device | CLASS II | Econo Sterile medical procedure kits labeled as recalled | Sklar Instruments | Sterility | Nationwide |
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| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |