ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2" CVD CASE/5...
FDA Device Recall #Z-0941-2025 — Class II — December 3, 2024
Recall Summary
| Recall Number | Z-0941-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 3, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Sklar Instruments |
| Location | West Chester, PA |
| Product Type | Devices |
| Quantity | 252865 units |
Product Description
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;
Reason for Recall
Reports of various packaging issues that may result in a breach of the sterile barrier.
Distribution Pattern
Domestic: Nationwide Distribution
Lot / Code Information
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.
Other Recalls from Sklar Instruments
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0946-2025 | Class II | ECONO STERILE medical procedure kits labeled as... | Dec 3, 2024 |
| Z-0936-2025 | Class II | ECONO STERILE medical procedure kits labeled as... | Dec 3, 2024 |
| Z-0931-2025 | Class II | ECONO STERILE medical procedure kits labeled as... | Dec 3, 2024 |
| Z-0939-2025 | Class II | ECONO STERILE medical procedure kits labeled as... | Dec 3, 2024 |
| Z-0943-2025 | Class II | ECONO STERILE medical procedure kits labeled as... | Dec 3, 2024 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.