is it on recall

Recall archive / FDA device enforcement

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286; 2)... — FDA record Z-0939-2025

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 ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286; 2) ECONO STERILE DRESSING FCP 5.5" CS/25LG,Model Number 94-0290; 3) ECONO STERILE TISSUE FCP 1X2 5.5" STER CS25,Model Number 94-0291; 4) ECONO STERILE FRCPS JANSEN BAYO STRL6.25 C25,Model Number 941-0691; 5) ECONO STERILE IRIS FCP SERR 4.25 STER CS100,Model Number 941-1414; 6) ECONO STERILE PEDIATRIC MAGILL CATH FCP CS25,Model Number 94-1924; 7) ECONO STERILE STRL ALLIGATOR FCPS 3.5" 25/CS,Model Number 94-5034; 8) ECONO STERILE SERR DRESSING FCP 5 1/2" CS/50,Model Number 94-6146; 9) ECONO STERILE KELLY RANKIN FCP CVD 6.25 CS25,Model Number 94-6616; 10) ECONO STERILE JANSEN NSL FCP BY6.5 STRLCS/25,Model Number 96-2215A; 11) ECONO STERILE BALLENGR SPNG FCP SERR7"CS/25,Model Number 96-2289; 12) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293; 13) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293A; 14) ECONO STERILE RUSSIAN TISSUE FCP 6" STER25,Model Number 96-2295A; 15) ECONO STERILE TISSUE FCP 1X2 8" STRL CS/25,Model Number 96-2351; 16) ECONO STERILE SCHROEDER BRAUN TEN FCP10CS/25,Model Number 96-2386; 17) ECONO STERILE TUBE OCCL FCP SM STR 7"STER 50,Model Number 96-2406; 18) ECONO STERILE TUBE OCC FCP SM STR 7" STER 25,Model Number 96-2408; 19) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 50,Model Number 96-2410; 20) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412; 21) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412A; 22) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412M; 23) ECONO STERILE SEMKEN DRESS FCP SERR 5"STER25,Model Number 96-2450M; 24) ECONO STERILE RANKIN KELLY FCP STR6.25 CS/25,Model Number 96-2461; 25) ECONO STERILE RANKIN KELLY FCP CVD6.25 CS/25,Model Number 96-2462; 26) ECONO STERILE IRIS FCP X-FINE ANG 3.5 STER25,Model Number 96-2470A; 27) ECONO STERILE IRIS FCP X-FINE STR 3.5 STER25,Model Number 96-2472A; 28) ECONO STERILE IRIS FCP 1/2CVD SERR STER CS25,Model Number 96-2515; 29) ECONO STERILE IRIS FCP 1/2CVD 1x2 STER CS25,Model Number 96-2515A; 30) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER50,Model Number 96-2532; 31) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER25,Model Number 96-2533; 32) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER25,Model Number 96-2533A; 33) ECONO STERILE SPONGE FCP STR SERR 9.5 STER25,Model Number 96-2533M; 34) ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25,Model Number 96-2534; 35) ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25,Model Number 96-2534A; 36) ECONO STERILE IRIS FCP STR 1X2 4" STER CS/25,Model Number 96-2535A; 37) ECONO STERILE HALSTED FCP STR 5" STER CS/50,Model Number 96-2536; 38) ECONO STERILE HALSTED FCP STR 5" STER CS/50,Model Number 96-2536M; 39) ECONO STERILE HALSTED FCP STR 5" STER CS/25,Model Number 96-2537; 40) ECONO STERILE HALSTED FCP STR 5" STER CS/25,Model Number 96-2537A; 41) ECONO STERILE HALSTED FCP STR 5" STER CS/25,Model Number 96-2537M; 42) ECONO STERILE HALSTED FCP CVD 5" STER CS/50,Mo...
Reason
Reports of various packaging issues that may result in a breach of the sterile barrier.
Classification
Class II
Recalling firm
Sklar Instruments
Quantity
245015 units
Agency-reported status
Ongoing
Source record identifier
Z-0939-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicability1) 94-0286, UDI/DI 50649111094406, Lot codes: FSF21; 2) 94-0290, UDI/DI 50649111095045, Lot codes: SK-115; 3) 94-0291, UDI/DI 50649111095144, Lot codes: 824940291, 924940291; 4) 941-0691, UDI/DI 50649111307902, Lot codes: MST8, MST9; 5) 941-1414, UDI/DI 50649111464872, Lot codes: SK-122; 6) 94-1924, UDI/DI 50649111345775, Lot codes: FSF16, FSF22; 7) 94-5034, UDI/DI 50649111040687, Lot codes: SK-112, SK-135; 8) 94-6146, UDI/DI 50649111215535, Lot codes: SK-135; 9) 94-6616, UDI/DI 50649111287457, Lot codes: SK-132; 10) 96-2215A, UDI/DI 50649111487567, Lot codes: HSI; 11) 96-2289, UDI/DI 50649111439986, Lot codes: SK-116; 12) 96-2293, UDI/DI 50649111440012, Lot codes: SK-115, SK-132; 13) 96-2293A, UDI/DI 50649111487598, Lot codes: HSI; 14) 96-2295A, UDI/DI 50649111493254, Lot codes: HST21; 15) 96-2351, UDI/DI 50649111440081, Lot codes: FST21; 16) 96-2386, UDI/DI 50649111440241, Lot codes: FSF18; 17) 96-2406, UDI/DI 50649111035195, Lot codes: FSF18, FSF24, FSF25; 18) 96-2408, UDI/DI 50649111035355, Lot codes: FSF5, FSF12, FSF18, FSF26; 19) 96-2410, UDI/DI 50649111035669, Lot codes: FST9; 20) 96-2412, UDI/DI 50649111035867, Lot codes: FST6, FST9, FST10, FST11, FST12, FST20; 21) 96-2412A, UDI/DI 50649111487550, Lot codes: SK-112; 22) 96-2412M, UDI/DI 50649111027015, Lot codes: 0724962412M; 23) 96-2450M, UDI/DI 50649111464483, Lot codes: 0624962450M; 24) 96-2461, UDI/DI 50649111440432, Lot codes: SK-132; 25) 96-2462, UDI/DI 50649111464490, Lot codes: SK-132; 26) 96-2470A, UDI/DI 50649111487970, Lot codes: SK-112; 27) 96-2472A, UDI/DI 50649111487987, Lot codes: SK-112; 28) 96-2515, UDI/DI 50649111050235, Lot codes: SK-115; 29) 96-2515A, UDI/DI 50649111487857, Lot codes: SK-112; 30) 96-2532, UDI/DI 50649111053212, Lot codes: FSF8, FSF14; 31) 96-2533, UDI/DI 50649111053397, Lot codes: FSF8, FSF11, FSF14, FSF16, FSF17, FSF20, FSF21, FSF22, FSF23; 32) 96-2533A, UDI/DI 50649111487888, Lot codes: HSI; 33) 96-2533M, UDI/DI 50649111215313, Lot codes: SK-116; 34) 96-2534, UDI/DI 50649111478817, Lot codes: FSF15, FSF21, FSF22, FSF23; 35) 96-2534A, UDI/DI 50649111492653, Lot codes: HSF8, HSF18; 36) 96-2535A, UDI/DI 50649111488304, Lot codes: SK-112; 37) 96-2536, UDI/DI 50649111054172, Lot codes: FSF10, FSF21; 38) 96-2536M, UDI/DI 50649111220034, Lot codes: 0724962536M; 39) 96-2537, UDI/DI 50649111054424, Lot codes: FSF5, FSF10; 40) 96-2537A, UDI/DI 50649111219496, Lot codes: SK-112; 41) 96-2537M, UDI/DI 50649111221758, Lot codes: 0724962537M; 42) 96-2538, UDI/DI 50649111054639, Lot codes: FSF10, FSF14, FSF18, FSF20, FSF21, FSF22, FSF23; 43) 96-2539, UDI/DI 50649111054783, Lot codes: FSF5, FSF6, FSF10, FSF12, FSF13, FSF14, FSF18, FSF21, FSF22, FSF24; 44) 96-2539A, UDI/DI 50649111487901, Lot codes: SK-112; 45) 96-2539M, UDI/DI 50649111225336, Lot codes: 0724962539M; 46) 96-2544, UDI/DI 50649111056008, Lot codes: FSF8, FSF10; 47) 96-2545, UDI/DI 50649111056183, Lot codes: FSF10, FSF21; 48) 96-2547, UDI/DI 50649111056497, Lot codes: FSF8, FSF10, FSF13, FSF20, FSF21, FSF22, FSF24, FSF26; 49) 96-2547A, UDI/DI 50649111236417, Lot codes: SK-112, SK-136; 50) 96-2548, UDI/DI 50649111056725, Lot codes: FSF12; 51) 96-2549, UDI/DI 50649111056800, Lot codes: FSF8, FSF17, FSF26; 52) 96-2550, UDI/DI 50649111057135, Lot codes: FSF9, FSF19, FSF22, FSF24; 53) 96-2551, UDI/DI 50649111057234, Lot codes: FSF9, FSF20, FSF24, FSF25; 54) 96-2551A, UDI/DI 50649111487819, Lot codes: SK-112; 55) 96-2552, UDI/DI 50649111057579, Lot codes: FSF13, FSF14, FSF16, FSF21, FSF24; 56) 96-2552M, UDI/DI 50649111400818, Lot codes: SK-133; 57) 96-2553, UDI/DI 50649111057715, Lot codes: FSF5; 58) 96-2554, UDI/DI 50649111057814, Lot codes: SK-134; 59) 96-2555, UDI/DI 50649111057982, Lot codes: FSF19, FSF20, FSF26; 60) 96-2556, UDI/DI 50649111058248, Lot codes: SK-131; 61) 96-2557, UDI/DI 50649111058545, Lot codes: FSF19, FSF26; 62) 96-2558, UDI/DI 50649111058644, Lot codes: SK-131; 63) 96-2559, UDI/DI 50649111058903, Lot codes: SK-115; 64) 96-2559A, UDI/DI 50649111487635, Lot codes: SK-112; 65) 96-2560, UDI/DI 50649111059078, Lot codes: FSF13, FSF14, FSF19, FSF20, FSF21, FSF22, FSF24, FSF25, FSF26; 66) 96-2561, UDI/DI 50649111059290, Lot codes: FSF5, FSF7, FSF8, FSF9, FSF19, FSF20, FSF22, FSF24; 67) 96-2561A, UDI/DI 50649111488007, Lot codes: SK-112; 68) 96-2561M, UDI/DI 50649111259041, Lot codes: 0724962561M; 69) 96-2562, UDI/DI 50649111059511, Lot codes: FSF7, FSF8, FSF11, FSF12, FSF18, FSF19, FSF21, FSF22, FSF26; 70) 96-2563, UDI/DI 50649111059733, Lot codes: FSF5, FSF9, FSF12, FSF14, FSF17, FSF21, FSF22, FSF24; 71) 96-2563A, UDI/DI 50649111487994, Lot codes: SK-112; 72) 96-2563M, UDI/DI 50649111262218, Lot codes: 0724962563M; 73) 96-2566A, UDI/DI 50649111488175, Lot codes: SK-112; 74) 96-2568, UDI/DI 50649111060531, Lot codes: FST13, FST21; 75) 96-2568A, UDI/DI 50649111267558, Lot codes: SK-115; 76) 96-2569, UDI/DI 50649111060715, Lot codes: FST9, FST10, FST21; 77) 96-2569A, UDI/DI 50649111487840, Lot codes: HSI; 78) 96-2570, UDI/DI 50649111060845, Lot codes: SK-115; 79) 96-2570M, UDI/DI 50649111271821, Lot codes: SK-116; 80) 96-2571, UDI/DI 50649111061033, Lot codes: SK-115; 81) 96-2571A, UDI/DI 50649111487642, Lot codes: HSI; 82) 96-2571M, UDI/DI 50649111273498, Lot codes: SK-116; 83) 96-2572, UDI/DI 50649111061187, Lot codes: SK-115; 84) 96-2573, UDI/DI 50649111061408, Lot codes: SK-115, SK-130; 85) 96-2573A, UDI/DI 50649111487758, Lot codes: HSI; 86) 96-2573M, UDI/DI 50649111276697, Lot codes: SK-115, SK-116; 87) 96-2575, UDI/DI 50649111061644, Lot codes: FSF9; 88) 96-2575A, UDI/DI 50649111487789, Lot codes: SK-112; 89) 96-2576, UDI/DI 50649111061897, Lot codes: FSF9; 90) 96-2578, UDI/DI 50649111062375, Lot codes: 724962578; 91) 96-2579, UDI/DI 50649111062542, Lot codes: 724962579; 92) 96-2579M, UDI/DI 50649111285576, Lot codes: 0724962579M; 93) 96-2588, UDI/DI 50649111064096, Lot codes: SK-115; 94) 96-2620, UDI/DI 50649111070493, Lot codes: SK-130; 95) 96-2622, UDI/DI 50649111070851, Lot codes: SK-130, SK-131; 96) 96-2622A, UDI/DI 50649111487802, Lot codes: SK-112; 97) 96-2623A, UDI/DI 50649111488205, Lot codes: SK-112, SK-134; 98) 96-2624, UDI/DI 50649111071209, Lot codes: FSF12, FSF17, FSF18, FSF19, FSF20, FSF22, FSF23, FSF24, FSF25; 99) 96-2624A, UDI/DI 50649111488212, Lot codes: SK-112; 100) 96-2626, UDI/DI 50649111071476, Lot codes: FSF15, FSF22; 101) 96-2653, UDI/DI 50649111076525, Lot codes: FSF8, FSF9, FSF18, FSF20, FSF24; 102) 96-2655, UDI/DI 50649111077027, Lot codes: SK-115; 103) 96-2656, UDI/DI 50649111077072, Lot codes: SK-115; 104) 96-2657, UDI/DI 50649111077232, Lot codes: FSF8, FSF10; 105) 96-2658, UDI/DI 50649111077461, Lot codes: FSF10, FSF17, FSF18, FSF24; 106) 96-2660, UDI/DI 50649111077928, Lot codes: FST10, FST13; 107) 96-2661, UDI/DI 50649111078024, Lot codes: 724962661; 108) 96-2670, UDI/DI 50649111079588, Lot codes: SK-115; 109) 96-2670M, UDI/DI 50649111034556, Lot codes: 0724962670M; 110) 96-2684, UDI/DI 50649111081703, Lot codes: SK-116; 111) 96-2685, UDI/DI 50649111081857, Lot codes: SK-116; 112) 96-2685A, UDI/DI 50649111488038, Lot codes: 60359; 113) 96-2687A, UDI/DI 50649111488311, Lot codes: 60431; 114) 96-2688, UDI/DI 50649111082335, Lot codes: SK-115; 115) 96-2689, UDI/DI 50649111082472, Lot codes: SK-116; 116) 96-2706, UDI/DI 50649111084995, Lot codes: SK-130; 117) 96-2736A, UDI/DI 50649111487918, Lot codes: SK-112; 118) 96-2737A, UDI/DI 50649111488106, Lot codes: SK-112; 119) 96-2738A, UDI/DI 50649111487956, Lot codes: SK-112; 120) 96-2739A, UDI/DI 50649111487963, Lot codes: SK-112, SK-133; 121) 96-2764A, UDI/DI 50649111487871, Lot codes: SK-112; 122) 96-2765, UDI/DI 50649111094185, Lot codes: FST16; 123) 96-2772A, UDI/DI 50649111492585, Lot codes: HSF26; 124) 96-2773A, UDI/DI 50649111492592, Lot codes: SK-133, SK-134; 125) 96-2775, UDI/DI 50649111095793, Lot codes: SK-115; 126) 96-2776A, UDI/DI 50649111492981, Lot codes: SK-115; 127) 96-2777A, UDI/DI 50649111492974, Lot codes: SK-115; 128) 96-2779A, UDI/DI 50649111492967, Lot codes: SK-115; 129) 96-2785A, UDI/DI 50649111488076, Lot codes: HSI; 130) 96-2786A, UDI/DI 50649111488083, Lot codes: HSI; 131) 96-2787A, UDI/DI 50649111488090, Lot codes: HSI; 132) 96-2790A, UDI/DI 50649111488250, Lot codes: SK-112; 133) 96-2791A, UDI/DI 50649111488267, Lot codes: SK-112; 134) 96-2795, UDI/DI 50649111488366, Lot codes: FSF21, FSF24; 135) 96-2921, UDI/DI 50649111120525, Lot codes: FST9; 136) 96-2921A, UDI/DI 50649111480865, Lot codes: HSI; 137) 96-3006, UDI/DI 50649111134720, Lot codes: FSF8, FSF9, FSF26; 138) 96-3010, UDI/DI 50649111135482, Lot codes: FSF21; 139) 96-3015A, UDI/DI 50649111488182, Lot codes: SK-112; 140) 96-3016A, UDI/DI 50649111488199, Lot codes: SK-112; 141) 96-3020A, UDI/DI 50649111493179, Lot codes: HST12; 142) 96-3023A, UDI/DI 50649111493209, Lot codes: HST7; 143) 96-3025A, UDI/DI 50649111493223, Lot codes: HST12; 144) 96-3030A, UDI/DI 50649111492998, Lot codes: SK-134; 145) 96-3558A, UDI/DI 50649111487772, Lot codes: SK-112; 146) 96-3560, UDI/DI 50649111440890, Lot codes: SK-112, SK-131, SK-132; 147) 96-3560A, UDI/DI 50649111487765, Lot codes: SK-112; 148) 96-3566A, UDI/DI 50649111492691, Lot codes: SK-116; 149) 96-3615, UDI/DI 50649111449701, Lot codes: FST10.

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.

Related records

Medical devices recordsSklar Instruments records