Class II FDA device recall · Z-0941-2025

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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 it was recalled

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

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed 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.

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Domestic: Nationwide Distribution

Recall record

Recalling firm: Sklar Instruments
Product type: Devices
Recall number: Z-0941-2025
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: West Chester, PA
Recall initiated: 2024-12-03

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-0941-2025 · Source: openFDA enforcement.