Recall archive / FDA device enforcement

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2" CVD CASE/50,Model Number 941-0918... — FDA record Z-0941-2025

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. Source coverage and dates.

What the record says

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,Mod...
Reason: Reports of various packaging issues that may result in a breach of the sterile barrier.
Classification: Class II
Recalling firm: Sklar Instruments
Quantity: 252865 units
Agency-reported status: Ongoing
Source record identifier: Z-0941-2025

Open the official record

What the recall classes mean. 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) 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 codes HSI; 28) 96-2495A, UDI/DI 50649111488236, Lot codes HSI; 29) 96-2496, UDI/DI 50649111440630, Lot codes SK-127; 30) 96-2497, UDI/DI 50649111046924, Lot codes SK-127; 31) 96-2499, UDI/DI 50649111047341, Lot codes 824962499; 32) 96-2500, UDI/DI 50649111047617, Lot codes FSS7, FSS10, FSS26; 33) 96-2500A, UDI/DI 50649111487581, Lot codes HSI; 34) 96-2502, UDI/DI 50649111048041, Lot codes FSS7, FSS9, FSS10, FSS11, FSS15, FSS16, FSS19, FSS20; 35) 96-2502M, UDI/DI 50649111169289, Lot codes SK-133; 36) 96-2503, UDI/DI 50649111048225, Lot codes FSS5, FSS11, FSS15, FSS22; 37) 96-2503A, UDI/DI 50649111487574, Lot codes HSI; 38) 96-2504, UDI/DI 50649111048386, Lot codes FSS7, FSS8, FSS16, FSS17, FSS23, FSS26; 39) 96-2505, UDI/DI 50649111048577, Lot codes FSS5, FSS6; 40) 96-2505A, UDI/DI 50649111487628, Lot codes HSI; 41) 96-2506, UDI/DI 50649111048799, Lot codes SK-127; 42) 96-2506M, UDI/DI 50649111174535, Lot codes MSS8; 43) 96-2507, UDI/DI 50649111049017, Lot codes SK-124, SK-127; 44) 96-2507A, UDI/DI 50649111488243, Lot codes HSI; 45) 96-2511A, UDI/DI 50649111480704, Lot codes 60577; 46) 96-2512, UDI/DI 50649111049819, Lot codes FSS13, FSS15, FSS17, FSS19, FSS24; 47) 96-2513, UDI/DI 50649111050006, Lot codes FSS15; 48) 96-2514, UDI/DI 50649111050129, Lot codes FSS8; 49) 96-2516, UDI/DI 50649111050402, Lot codes SK-130; 50) 96-2517, UDI/DI 50649111050594, Lot codes SK-130; 51) 96-2517A, UDI/DI 50649111487680, Lot codes SK-112; 52) 96-2519, UDI/DI 50649111050976, Lot codes SK-126; 53) 96-2520, UDI/DI 50649111051119, Lot codes FSS7, FSS8, FSS10, FSS11, FSS16, FSS23; 54) 96-2520A, UDI/DI 50649111194090, Lot codes FSS8, FSS20, HSS8, HSS9, HSS17, HSS19; 55) 96-2521, UDI/DI 50649111051256, Lot codes FSS5, FSS8, FSS10, FSS19, FSS20, FSS22, FSS23, FSS24; 56) 96-2521A, UDI/DI 50649111487659, Lot codes SK-112; 57) 96-2522, UDI/DI 50649111051416, Lot codes FSS8, FSS20, FSS23, FSS24, FSS26; 58) 96-2523, UDI/DI 50649111051584, Lot codes FSS7, FSS8, FSS10, FSS17, FSS19, FSS20, FSS22; 59) 96-2523A, UDI/DI 50649111487666, Lot codes SK-112; 60) 96-2523M, UDI/DI 50649111199880, Lot codes MSS10; 61) 96-2524, UDI/DI 50649111051638, Lot codes FSS26; 62) 96-2527, UDI/DI 50649111052215, Lot codes FSS26; 63) 96-2530, UDI/DI 50649111052802, Lot codes FSS6, FSS7, FSS10, FSS20, FSS22, FSS24; 64) 96-2531, UDI/DI 50649111053069, Lot codes FSS5; 65) 96-2531A, UDI/DI 50649111487673, Lot codes SK-112; 66) 96-2592, UDI/DI 50649111064911, Lot codes FSS13; 67) 96-2593, UDI/DI 50649111065031, Lot codes FSS13; 68) 96-2596, UDI/DI 50649111065826, Lot codes FSF26; 69) 96-2596M, UDI/DI 50649111311275, Lot codes SK-133; 70) 96-2597, UDI/DI 50649111065888, Lot codes FSS10, FSS21, FSS24; 71) 96-2598, UDI/DI 50649111066205, Lot codes FSS10, FSS24, FSS25; 72) 96-2640, UDI/DI 50649111074347, Lot codes FSS20; 73) 96-2649, UDI/DI 50649111075849, Lot codes FSS10, FSS12, FSS13, FSS15, FSS16, FSS18, FSS20, FSS21; 74) 96-2649G, UDI/DI 50649111005082, Lot codes FSS8, FSS10, FSS12, FSS13, FSS15, FSS16, FSS17, FSS20; 75) 96-2650, UDI/DI 50649111076198, Lot codes FSS8, FSS16, FSS17, FSS22, FSS23, FSS24, FSS26; 76) 96-2651, UDI/DI 50649111076266, Lot codes SK-127, SK-129; 77) 96-2654, UDI/DI 50649111076884, Lot codes FSS9, FSS10, FSS16, FSS19; 78) 96-2662, UDI/DI 50649111078246, Lot codes FSS13, FSS15; 79) 96-2673A, UDI/DI 50649111493056, Lot codes SK-134; 80) 96-2680, UDI/DI 50649111081109, Lot codes FSS20, FSS22, FSS26; 81) 96-2682, UDI/DI 50649111081499, Lot codes FSS10, FSS13, FSS21, FSS22, FSS26; 82) 96-2682A, UDI/DI 50649111487703, Lot codes SK-112; 83) 96-2683A, UDI/DI 50649111487710, Lot codes HSI; 84) 96-2690A, UDI/DI 50649111487727, Lot codes HSI; 85) 96-2691A, UDI/DI 50649111487734, Lot codes HSI; 86) 96-2703, UDI/DI 50649111084537, Lot codes 724962703; 87) 96-2704, UDI/DI 50649111084735, Lot codes 724962704; 88) 96-2720A, UDI/DI 50649111487697, Lot codes SK-112; 89) 96-2728, UDI/DI 50649111088221, Lot codes FSS10, FSS13, FSS24.

Label field

Details supplied by the agency

Lot, code or applicability

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 codes HSI; 28) 96-2495A, UDI/DI 50649111488236, Lot codes HSI; 29) 96-2496, UDI/DI 50649111440630, Lot codes SK-127; 30) 96-2497, UDI/DI 50649111046924, Lot codes SK-127; 31) 96-2499, UDI/DI 50649111047341, Lot codes 824962499; 32) 96-2500, UDI/DI 50649111047617, Lot codes FSS7, FSS10, FSS26; 33) 96-2500A, UDI/DI 50649111487581, Lot codes HSI; 34) 96-2502, UDI/DI 50649111048041, Lot codes FSS7, FSS9, FSS10, FSS11, FSS15, FSS16, FSS19, FSS20; 35) 96-2502M, UDI/DI 50649111169289, Lot codes SK-133; 36) 96-2503, UDI/DI 50649111048225, Lot codes FSS5, FSS11, FSS15, FSS22; 37) 96-2503A, UDI/DI 50649111487574, Lot codes HSI; 38) 96-2504, UDI/DI 50649111048386, Lot codes FSS7, FSS8, FSS16, FSS17, FSS23, FSS26; 39) 96-2505, UDI/DI 50649111048577, Lot codes FSS5, FSS6; 40) 96-2505A, UDI/DI 50649111487628, Lot codes HSI; 41) 96-2506, UDI/DI 50649111048799, Lot codes SK-127; 42) 96-2506M, UDI/DI 50649111174535, Lot codes MSS8; 43) 96-2507, UDI/DI 50649111049017, Lot codes SK-124, SK-127; 44) 96-2507A, UDI/DI 50649111488243, Lot codes HSI; 45) 96-2511A, UDI/DI 50649111480704, Lot codes 60577; 46) 96-2512, UDI/DI 50649111049819, Lot codes FSS13, FSS15, FSS17, FSS19, FSS24; 47) 96-2513, UDI/DI 50649111050006, Lot codes FSS15; 48) 96-2514, UDI/DI 50649111050129, Lot codes FSS8; 49) 96-2516, UDI/DI 50649111050402, Lot codes SK-130; 50) 96-2517, UDI/DI 50649111050594, Lot codes SK-130; 51) 96-2517A, UDI/DI 50649111487680, Lot codes SK-112; 52) 96-2519, UDI/DI 50649111050976, Lot codes SK-126; 53) 96-2520, UDI/DI 50649111051119, Lot codes FSS7, FSS8, FSS10, FSS11, FSS16, FSS23; 54) 96-2520A, UDI/DI 50649111194090, Lot codes FSS8, FSS20, HSS8, HSS9, HSS17, HSS19; 55) 96-2521, UDI/DI 50649111051256, Lot codes FSS5, FSS8, FSS10, FSS19, FSS20, FSS22, FSS23, FSS24; 56) 96-2521A, UDI/DI 50649111487659, Lot codes SK-112; 57) 96-2522, UDI/DI 50649111051416, Lot codes FSS8, FSS20, FSS23, FSS24, FSS26; 58) 96-2523, UDI/DI 50649111051584, Lot codes FSS7, FSS8, FSS10, FSS17, FSS19, FSS20, FSS22; 59) 96-2523A, UDI/DI 50649111487666, Lot codes SK-112; 60) 96-2523M, UDI/DI 50649111199880, Lot codes MSS10; 61) 96-2524, UDI/DI 50649111051638, Lot codes FSS26; 62) 96-2527, UDI/DI 50649111052215, Lot codes FSS26; 63) 96-2530, UDI/DI 50649111052802, Lot codes FSS6, FSS7, FSS10, FSS20, FSS22, FSS24; 64) 96-2531, UDI/DI 50649111053069, Lot codes FSS5; 65) 96-2531A, UDI/DI 50649111487673, Lot codes SK-112; 66) 96-2592, UDI/DI 50649111064911, Lot codes FSS13; 67) 96-2593, UDI/DI 50649111065031, Lot codes FSS13; 68) 96-2596, UDI/DI 50649111065826, Lot codes FSF26; 69) 96-2596M, UDI/DI 50649111311275, Lot codes SK-133; 70) 96-2597, UDI/DI 50649111065888, Lot codes FSS10, FSS21, FSS24; 71) 96-2598, UDI/DI 50649111066205, Lot codes FSS10, FSS24, FSS25; 72) 96-2640, UDI/DI 50649111074347, Lot codes FSS20; 73) 96-2649, UDI/DI 50649111075849, Lot codes FSS10, FSS12, FSS13, FSS15, FSS16, FSS18, FSS20, FSS21; 74) 96-2649G, UDI/DI 50649111005082, Lot codes FSS8, FSS10, FSS12, FSS13, FSS15, FSS16, FSS17, FSS20; 75) 96-2650, UDI/DI 50649111076198, Lot codes FSS8, FSS16, FSS17, FSS22, FSS23, FSS24, FSS26; 76) 96-2651, UDI/DI 50649111076266, Lot codes SK-127, SK-129; 77) 96-2654, UDI/DI 50649111076884, Lot codes FSS9, FSS10, FSS16, FSS19; 78) 96-2662, UDI/DI 50649111078246, Lot codes FSS13, FSS15; 79) 96-2673A, UDI/DI 50649111493056, Lot codes SK-134; 80) 96-2680, UDI/DI 50649111081109, Lot codes FSS20, FSS22, FSS26; 81) 96-2682, UDI/DI 50649111081499, Lot codes FSS10, FSS13, FSS21, FSS22, FSS26; 82) 96-2682A, UDI/DI 50649111487703, Lot codes SK-112; 83) 96-2683A, UDI/DI 50649111487710, Lot codes HSI; 84) 96-2690A, UDI/DI 50649111487727, Lot codes HSI; 85) 96-2691A, UDI/DI 50649111487734, Lot codes HSI; 86) 96-2703, UDI/DI 50649111084537, Lot codes 724962703; 87) 96-2704, UDI/DI 50649111084735, Lot codes 724962704; 88) 96-2720A, UDI/DI 50649111487697, Lot codes SK-112; 89) 96-2728, UDI/DI 50649111088221, Lot codes FSS10, FSS13, FSS24.

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.

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 the record says

Lot and product identifiers

Distribution

Dates in the source

Related records