FDA Medical devices recall · January 22, 2025

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

Read the official FDA notice ↗

Product

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2" CVD CASE/50,Model Number 941-0918; 2) ECONO STERILE METZENBAUM SCIS STR 9"STER C25,Model Number 941-1556; 3) ECONO STERILE MAYO SCISS STRT STRL 9" CS/25,Model Number 941-1613; 4) ECONO STERILE OPERATING SCISSOR 5.5" B/B C50,Model Number 94-1346; 5) ECONO STERILE MAYO SCISS STR 5.5" CS/50,Model Number 94-1925; 6) ECONO STERILE OR SCISSORS/FORCEP TRAY 50/CS,Model Number 94-4091; 7) ECONO STERILE WIRE SCISSORS SURGI-OR CS/50,Model Number 94-5692; 8) ECONO STERILE MAYO SCIS STR 6.75" STER CS/50,Model Number 94-6096; 9) ECONO STERILE MAYO SCIS CVD 6.75 STER CS/50,Model Number 94-6097; 10) ECONO STERILE UTILITY SCISS YELL ST CS25 7",Model Number 96-1220; 11) ECONO STERILE UTILITY SCISS ORNG ST CS25 7",Model Number 96-1221; 12) ECONO STERILE UTILITY SCISS PRPL ST CS25 7",Model Number 96-1222; 13) ECONO STERILE UTILITY SCISSOR MAG ST CS25 7",Model Number 96-1224; 14) ECONO STERILE UTILITY SCISSOR RYL ST CS25 7",Model Number 96-1226; 15) ECONO STERILE UTILITY SCISS LM GR ST CS25 7",Model Number 96-1228; 16) ECONO STERILE MAYO DISS SCISS STR 9" STER25,Model Number 96-2260; 17) ECONO STERILE MAYO DISS SCISS CV 9"STRLCS/25,Model Number 96-2261; 18) ECONO STERILE MAYO DISS SCISS CVD 9" STER25,Model Number 96-2261A; 19) ECONO STERILE METZENBAUM SCIS STR7"STRLCS/25,Model Number 96-2263A; 20) ECONO STERILE METZENBAUM SCIS STR9"STER CS25,Model Number 96-2266; 21) ECONO STERILE MAYO DISS SCISS CVD 5.5"CS/25,Model Number 96-2433; 22) ECONO STERILE MAYO DISS SCISS CVD 6.75"CS/25,Model Number 96-2435; 23) ECONO STERILE METZ-NELSON SCISS CVD 9" CS/25,Model Number 96-2437; 24) ECONO STERILE METZ-NELSON SCISS CVD 9" CS/25,Model Number 96-2437A; 25) ECONO STERILE IRIS SCISS CVD S/S 3.5" CS/25,Model Number 96-2471; 26) ECONO STERILE TOENAIL SCISS CVD 4.5" STER 25,Model Number 96-2492A; 27) ECONO STERILE IRIS SCIS CVD DEL 4 STER CS/25,Model Number 96-2494A; 28) ECONO STERILE IRIS SCIS STR LG RG 4.5 STER25,Model Number 96-2495A; 29) ECONO STERILE IRIS SCISS STR S/S 3.5" CS/25,Model Number 96-2496; 30) ECONO STERILE IRIS SCIS STR S/S 3.5 STER C50,Model Number 96-2497; 31) ECONO STERILE IRIS SCIS CVD S/S 3.5 STER C50,Model Number 96-2499; 32) ECONO STERILE LISTER BAND SCISS 7 1/4" CS/25,Model Number 96-2500; 33) ECONO STERILE LISTER BAND SCISS 7 1/4" CS/25,Model Number 96-2500A; 34) ECONO STERILE LISTER BAND SCISS 5.5 STER C50,Model Number 96-2502; 35) ECONO STERILE LISTER BAND SCIS STER 5 1/2 50,Model Number 96-2502M; 36) ECONO STERILE LISTER BAND SCIS STER 5 1/2 25,Model Number 96-2503; 37) ECONO STERILE LISTER BAND SCIS STER 5 1/2 25,Model Number 96-2503A; 38) ECONO STERILE IRIS SCIS STR S/S 4.5 STER C50,Model Number 96-2504; 39) ECONO STERILE IRIS SCISS STR 4.5" STER CS/25,Model Number 96-2505; 40) ECONO STERILE IRIS SCISS STR 4.5" STER CS/25,Model Number 96-2505A; 41) ECONO STERILE IRIS SCIS CVD S/S 4.5 STER C50,Model Number 96-2506; 42) ECONO STERILE IRIS SCISS CVD 4.5" STER CS/50,Model Number 96-2506M; 43) ECONO STERILE IRIS SCISS CVD 4.5" STER CS/25,Model Number 96-2507; 44) ECONO STERILE IRIS SCISS CVD 4.5" STER CS/25,Model Number 96-2507A; 45) ECONO STERILE SPENCER ST SCIS DEL 3.5 STER25,Model Number 96-2511A; 46) ECONO STERILE LITT SUT SCIS 5 1/2 STER CS/50,Model Number 96-2512; 47) ECONO STERILE LITT SUT SCISS 5 1/2 STER CS25,Model Number 96-2513; 48) ECONO STERILE OR SCIS STR B/B 5.5" STER CS50,Model Number 96-2514; 49) ECONO STERILE METZ SCISS STR STER 5.5" CS/50,Model Number 96-2516; 50) ECONO STERILE METZ SCISS STR STER 5.5" 25/CS,Model Number 96-2517; 51) ECONO STERILE METZ SCISS STRS 5.5" STER CS25,Model Number 96-2517A; 52) ECONO STERILE WIRE CUT SCIS ANG 4 3/4 STRL25,Model Number 96-2519; 53) ECONO STERILE OR SCISS STR S/B 5.5" STER C50,Model Number 96-2520; 54) ECONO STERILE OR SCIS STR S/B 5.5 STER CS50,Model Number 96-2520A;

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) 941-0918, UDI/DI 50649111344174, Lot codes MSS8; 2) 941-1556, UDI/DI 50649111447752, Lot codes FSS19, FSS23; 3) 941-1613, UDI/DI 50649111447912, Lot codes FSS17; 4) 94-1346, UDI/DI 50649111256613, Lot codes FSS8; 5) 94-1925, UDI/DI 50649111345966, Lot codes FSS10, FSS17, FSS20; 6) 94-4091, UDI/DI 50649111288454, Lot codes FSK12; 7) 94-5692, UDI/DI 50649111150126, Lot codes FSS20; 8) 94-6096, UDI/DI 50649111207509, Lot codes FSS5, FSS10, FSS17; 9) 94-6097, UDI/DI 50649111207622, Lot codes FSS26; 10) 96-1220, UDI/DI 50649111246096, Lot codes 724961220; 11) 96-1221, UDI/DI 50649111246140, Lot codes 824961221; 12) 96-1222, UDI/DI 50649111246287, Lot codes 724961222; 13) 96-1224, UDI/DI 50649111246546, Lot codes 724961224; 14) 96-1226, UDI/DI 50649111246867, Lot codes 724961226; 15) 96-1228, UDI/DI 50649111247178, Lot codes 824961228; 16) 96-2260, UDI/DI 50649111492622, Lot codes FSS17, FSS21; 17) 96-2261, UDI/DI 50649111439870, Lot codes FSS5; 18) 96-2261A, UDI/DI 50649111492646, Lot codes HSS23; 19) 96-2263A, UDI/DI 50649111487536, Lot codes SK-112; 20) 96-2266, UDI/DI 50649111488359, Lot codes FSS23; 21) 96-2433, UDI/DI 50649111440357, Lot codes FSS5; 22) 96-2435, UDI/DI 50649111440371, Lot codes FSS8; 23) 96-2437, UDI/DI 50649111440395, Lot codes FSS17, FSF21, FSS24; 24) 96-2437A, UDI/DI 50649111487543, Lot codes HSI; 25) 96-2471, UDI/DI 50649111440524, Lot codes 724962471; 26) 96-2492A, UDI/DI 50649111493933, Lot codes 0824962492A; 27) 96-2494A, UDI/DI 50649111488229, Lot

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-0941-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.