Drug & Device Safety Atlas
Class II FDA device recall · Z-0939-2025

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 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,Model Number 96-2538; 43) ECONO STERILE HALSTED FCP CVD 5" STER CS/25,Model Number 96-2539; 44) ECONO STERILE HALSTED FCP CVD 5" STER CS/25,Model Number 96-2539A; 45) ECONO STERILE HALSTED FCP CVD 5" STER CS/25,Model Number 96-2539M; 46) ECONO STERILE ROCH PEAN FCP STR STER 61/4 50,Model Number 96-2544; 47) ECONO STERILE ROCH PEAN FCP STR STER 61/4 25,Model Number 96-2545; 48) ECONO STERILE ROCH PEAN CVD 6 1/4 STERL CS25,Model Number 96-2547; 49) ECONO STERILE ROCH PEAN CVD 6 1/4 STER CS/25,Model Number 96-2547A; 50) ECONO STERILE ROCH-PEAN FCP CVD 8.5" STER 25,Model Number 96-2548; 51) ECONO STERILE ROCH-PEAN FCP CVD 8.5" STER 50,Model Number 96-2549; 52) ECONO STERILE CRILE FCP STR 5.5" STERL CS/50,Model Number 96-2550; 53) ECONO STERILE CRILE FCP STR 5.5" STERL CS/25,Model Number 96-2551; 54) ECONO STERILE CRILE FCP STR 5.5" STERL CS/25,Model Number 96-2551A;

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) 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.

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-0939-2025
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-0939-2025 · Source: openFDA enforcement.