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Sklar Instruments recallZ-0941-2025 · Sklar Instruments · initiated Dec 3, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Sklar Instruments or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

On December 3, 2024 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Action required: 1. Check your inventory for any affected product lots (see Attachment A). If you have affected product in inventory, discontinue use immediately. 2. Notify Additional Users. If you have further distributed any of the items referenced in this notification, you must notify those downstream customers of this recall. Forward a copy of this letter, along with copies of Attachment A and the Recall Acknowledgement form, for such customers to complete and return to Sklar. 3. Notify Sklar. Please complete the enclosed Recall Acknowledgement form as soon as possible, indicating whether you do or do not have any of the affected products remaining in your inventory and whether you have distributed any of the affected products to downstream customers. Return the form to Sklar by e-mail to [email protected]. 4. Return the affected product. If you do have any of the affected products in inventory, Sklar customer service will contact you to arrange for the affected product to be returned. Sklar will credit its direct customers for returned affected product once it receives the affected product back. Sklar Instruments is committed to providing high quality, safe, and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have experienced an adverse event associated with any of these products, please contact us and/or report the event to FDA s MedWatch Adverse Event Reporting program online.

Recall details

Recall number
Z-0941-2025
Status
Open, Classified
Initiated by the company
Dec 3, 2024
Posted by the FDA
Jan 16, 2025
Recalling firm
Sklar Instruments
Quantity
252865 units
Product code
LRW
Distribution
Domestic: Nationwide Distribution

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;

Code information (models, lots, serial numbers)

Show the full code information (6k characters)

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.

Devices named in this recall

85 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 95946).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page