FDA Medical devices recall · January 22, 2025

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE… recall

Read the official FDA notice ↗

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

Why was it recalled?

Reports of various packaging issues that may result in a breach of the sterile barrier.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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, U

Distribution

Domestic: Nationwide Distribution

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-0954-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.