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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71394

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 01, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Stryker Sustainability Solutions

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

Z-1834-2015
Recall number
Z-1834-2015
Initiated
June 01, 2015
Classification
Class II
Status
Terminated
Quantity
147,351

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.

Code information

Lot Codes for Model CTF03: 314326, 362394, 365229, 401076, 413450, 420581, 420607, 420609, 428106, 428114, 429863, 429866, 456224, 456242, 459592, 459597, 459617, 459954, 461862, 464282, 466767, 467197, 467198, 467350, 467413, 468306, 468471, 468497, 468498, 468941, 469533, 469538, 469539, 469956, 469960, 470614, 471039, 471048, 471060, 471126, 471721, 471725, 471789, 471895, 471911, 471917, 473040, 473280, 473936, 474004, 474035, 474061, 474338, 474340, 474381, 474482, 474487, 474493, 474940, 475171, 475429, 475439, 476151, 476152, 476155, 476191, 476200, 476259, 476277, 476751, 476985, 476989, 477172, 477304, 477306, 477865, 478264, 478268, 478668, 479437, 479821, 480663, 480684, 481109, 481615, 481808, 481951, 481968, 481977, 482137, 482216, 482607, 482630, 482664, 482669, 482672, 482692, 482885, 482956, 482959, 483508, 483554, 483908, 483911, 483918, 483953, 483963, 485020, 485218, 485502, 485581, 485671, 485724, 486058, 486143, 486209, 486394, 486800, 486853, 486855, 487203, 488297, 488356, 488601, 489255, 489701, 489717, 489745, 489960, 490084, 490101, 490864, 490887, 491256, 491267, 491500, 600329, 600462, 600929, 601012, 601786, 601925, 601945, 602261, 1700377, 1742132, 1750017, 1752379, 1825271, 1831415, 1838630, 1854074, 1873579, 1924143, 1940389, 1993186, 1995046, 2026174, 2027905, 2099505, 2128128, 2141295, 2171826, 2175866, 2201812, 2202067, 2207903, 2222389, 2256944, 2279303, 2958995, 2959099, 2959393, 2967775, 2967953, 2967969, 2968684, 2971490, 2972179, 2972432, 2972523, 2974255, 2974595, 2974645, 2974873, 2976787, 2977905, 2978075, 2978215, 2979090, 2979438, 2980071, 2980305, 2983205, 2983527, 2985634, 2985741, 2985993, 2986317, 2986329, 2987002, 2989753, 2989851, 2990255, 2990970, 2991547, 2991801, 2994252, 2994268, 2996250, 2996278, 2998784, 3000843, 3003011, 3003146, 3003534, 3006299, 3006309, 3007744, 3017809, 3017897, 3019141, 3020340, 3020726, 3021288, 3022515, 3022527, 3025882, 3032891, 3032917, 3033615, 3033627, 3035146, 3035151, 3035575, 3035581, 3052047, 3052863, 3053399, 3053458, 3059535, 3059906, 3063793, 3064331, 3064527, 3065459, 3065519, 3069524, 3074847, 3074852, 3075234, 3075247, 3076850, 3078395, 3078400, 3079634, 3080357, 3080361, 3080763, 3081497, 3083566, 3089890, 3089900, 3092020, 3092255, 3092264, 3093953, 3094667, 3094985, 3094992, 3095005, 3095014, 3099954, 3099965, 3100547, 3102846, 3102851, 3103176, 3103343, 3103358, 3108380, 3110878, 3111384, 3111795, 3113296, 3114007, 3114011, 3115286, 3116045, 3116050, 3118392, 3118407, 3120168, 3120650, 3120716, 3122269, 3122276, 3126999, 3127514, 3129755, 3133588, 3135549, 3138676, 3138682, 3141395, 3142937, 3145355, 3145364, 3149085, 3149658, 3152031, 3152110, 3154888, 3156973, 3160045, 3161763, 3162732, 3165164, 3165571, 3168278, 3168767, 3170546, 3170551, 3172878, 3172884, 3175161, 3175541, 3183829, 3185529, 3188163, 3190831, 3194023, 3198793, 3201657, 3203692, 3206793, 3209459, 3213698, 3216157, 3219175, 3223419, 3227058, 3229265, 3231929, 3242541, 3242556, 3242692, 3251050, 3251066, 3251078, 3253575, 3253581, 3257175, 3257524, 3258813, 3262050, 3262499, 3265301, 3266817, 3267267, 3267280, 3267527, 3269037, 3269085, 3270954, 3271670, 3275447, 3275452, 3278598, 3279897, 3282553, 3284583, 3284596, 3288082, 3288789, 3289234, 3290049 Lot Codes for CTF73: 3180165, 3181358, 3181959, 3183394, 3183432, 3185966, 3186537, 3188429, 3189243, 3192067, 3193604, 3194941, 3194994, 3198107, 3198239, 3201661, 3202726, 3204497, 3204506, 3207156, 3207160, 3210263, 3210271, 3214365, 3214377, 3217385, 3217407, 3220601, 3220849, 3224735, 3224742, 3227313, 3227321, 3229541, 3229556, 3231972, 3231986, 3233272, 3235415, 3235685, 3237169, 3237447, 3238117, 3238439, 3248221, 3274181, 3274524, 3274530, 3274936, 3275097, 3277283, 3277296, 3277502, 3277600,, 3278329, 3280207, 3280211, 3280224, 3291838

Distribution pattern

Distributed Nationwide including Puerto Rico.

device · product 2 of 3

Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

Z-1835-2015
Recall number
Z-1835-2015
Initiated
June 01, 2015
Classification
Class II
Status
Terminated
Quantity
147,351

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.

Code information

Lot Codes for Model CTR03: 403486, 421850, 423482, 423498, 424916 459230, 459967, 459990, 460697, 462208, 465157, 465212, 470140, 471013, 471021, 471022, 471031, 471046, 471048, 471060, 471102, 471109, 471120 472125, 473260, 473295, 475478, 475488, 477315, 477866, 477886, 478318, 478338, 479079, 479670, 479673, 479821, 479828, 480465, 481745, 484011, 485511, 485557, 485567, 485591, 485622, 485656, 485660, 485669, 486112, 486138, 486142, 486150, 489568, 489957, 489962, 489979, 490076, 490086, 490088, 490758, 1992710, 1993479, 1997304, 1997315, 2000830, 2013237, 2014811, 2026372, 2026386, 2026408, 2035129, 2035138, 2035851, 2039108, 2039112 ,2047804, 2048945, 2049374, 2057081, 2060309, 2069618, 2070535, 2070588, 2071279, 2072131, 2100350, 2100378, 2111413, 2111421, 2114563, 2114585, 2114592, 2128288, 2128290, 2133045, 2134884, 2163528, 2175866, 2201534, 2201547, 2203131, 2203371, 2203562, 2208579, 2209452, 2209475, 2230529, 2232962, 2234218, 2236956, 2239309, 2241486, 2243783, 2244669, 2246728, 2248717, 2250745, 2252614, 2255994, 2259037, 2259059, 2261294, 2261304, 2261315, 2263727, 2263736, 2263743, 2265643, 2265658, 2265670, 2267530, 2267553, 2269653, 2269669, 2270325, 2271178, 2271184, 2275221, 2276869, 2282924, 2282948, 2284999, 2285029, 2287239, 2287241, 2288769, 2288776, 2290982, 2292454, 2292465, 2295737, 2295744, 2296614, 2297670, 2297691, 2299746, 2299751, 2300108, 2300120, 2315316, 2392083, 2392096, 2393026, 2393042, 2395363, 2395578, 2397485, 2397503, 2399456, 2399460, 2401371, 2401392, 2403422, 2406156, 2406160, 2407819, 2407826, 2409198, 2409200, 2485833, 2487715, 2489756, 2491428, 2493516, 2495477, 2497246, 2497251, 2499662, 2499670, 2499689, 2501927, 2501936, 2503726, 2503816, 2505908, 2505996, 2507620, 2507829, 2510016, 2510230, 2512012, 2512031, 2513625, 2587080, 2590965, 2603205, 2603214, 2603429, 2604554, 2604565, 2605022, 2605080, 2620626, 2621139, 2624943, 2628828, 2630134, 2632160, 2637735, 2642128, 2646037, 2647944, 2647971, 2648004, 2650432, 2650450, 2650715, 2652345, 2652378, 2652571, 2654365, 2654536, 2654543, 2659841, 2662099, 2708016, 2708997, 2710878, 2712010, 2713980, 2713998, 2717333, 2717720, 2718597, 2719039, 2719250, 2721394, 2721413, 2721510, 2723014, 2723067, 2723652, 2725429, 2725527, 2725706, 2727113, 2727355, 2727682, 2728922, 2728933, 2729512, 2729944, 2732547, 2732829, 2732838, 2734569, 2734595, 2735786, 2736154, 2736482, 2738317, 2739660, 2741664, 2744566, 2746216, 2746620, 2748498, 2749118, 2750852, 2754273, 2754826, 2755046, 2758292, 2759138, 2761771, 2762404, 2772543, 2775119, 2777153, 2777985 2781786, 2822857, 2823275, 2824051, 2824131, 2824149, 2824827, 2824993, 2826122, 2826360, 2826665, 2830363, 2830532, 2830675, 2830787, 2830889, 2831336, 2831646, 2831826, 2832542, 2832601, 2833466, 2833926, 2839788, 2841575, 2841581, 2842847, 2842984, 2845233, 2846463, 2848310, 2848709, 2851374, 2851480, 2853109, 2853338, 2855247, 2855473, 2856641, 2857180 2857198, 2858798, 2861778, 2861895, 2864786, 2874082, 2875168, 2879999, 2884054, 2884582, 2904497, 2904801, 2905958, 2906182, 2906406, 2908120,2908131, 2911611, 2911624, 2913130, 2913701, 2914205, 2924598, 2924918, 2924925, 2925373, 2934780, 2935038, 2935190, 2935933, 2935946, 2937667, 2937679, 2939581, 2939715, 2940225, 2940481, 2943258, 2943262, 2943386, 2944160, 2945439, 2945441, 2947200, 2947216, 2947974, 2950242, 2950411, 2950634, 2952923, 2953373, 2953704, 2961910, 2962343, 2963500, 2963516, 2963603, 2963851, 2965844, 2966122, 2966608, 2967100, 2967116, 2968697, 2969765, 2971322, 2973968, 2974054, 2975554, 2976098, 2977103, 2977119, 2977458, 2980913, 2981265, 2983775, 2983878, 2988228, 2988497, 2989384, 2989544, 2994027, 2994635, 2995969, 2996213, 2999900, 3006281, 3018106, 3020338, 3021862, 3024266, 3027013, 3027021, 3029259, 3032005, 3034215, 3055077, 3055181, 3057207, 3057211, 3059041, 3059369, 3062996, 3063009, 3066692, 3067647, 3067652, 3070857, 3070861, 3072895, 3072905, 3075954, 3076845, 3078896, 3079647, 3081872, 3082712, 3084776, 3084782, 3087477, 3087483, 3089874, 3089888, 3090834, 3092012, 3092451, 3093267, 3096109, 3098198, 3127329, 3128135, 3135738, 3149071, 3152970, 3152989, 3154423, 3162323, 3162914, 3165015, 3165299, 3168779, 3182561, 3211676, 3298040 Lot Codes for Model CTR73: 336923, 423482, 423498, 459996, 466789, 468474, 469956, 471031, 471048, 471060, 471067, 471082, 471109, 471120, 471126, 471131, 471135, 471136, 472125, 473040, 476126, 476158, 476190, 479673, 482137, 482692, 485506, 485591, 486142, 486143, 486618, 489957, 490076, 490086, 490758, 1997327, 1997336, 2000848, 2001693, 2001705, 2026420, 2026431, 2035140, 2035155, 2035867, 2035908, 2039131, 2039149, 2042908, 2042912, 2043698, 2043701, 2043717, 2043738, 2046967, 2047815, 2047827, 2048966, 2049361, 2053014, 2054619, 2054635, 2054642, 2055144, 2055163, 2055171, 2055185, 2059651, 2059679, 2061398, 2063324, 2063348, 2102575, 2113203, 2113725, 2118323, 2118334, 2126577, 2148897, 2150757, 2150761, 2152781, 2167635, 2175866, 2226267, 2228400, 2230834, 2237073, 2239345, 2241591, 2245133, 2245727, 2246700, 2246818, 2248729, 2250713, 2259490, 2261410, 2261423, 2267511, 2267524, 2269454, 2269477, 2271166, 2273985, 2275968, 2276876, 2279293, 2279326, 2281261, 2301842, 2301861, 2303568, 2303575, 2305295, 2306592, 2310470, 2312596, 2313332, 2313571, 2315316, 2324245, 2324250, 2334291, 2334317, 2340769, 2340782, 2343910, 2344414, 2344422, 2345370, 2345389, 2350222, 2350799, 2352624, 2354510, 2354523, 2354534, 2356343, 2356370, 2356389, 2359906, 2359910, 2361956, 2361960, 2476206, 2476949, 2476965, 2487727, 2487736, 2490685, 2491437, 2491444, 2492835, 2493954, 2494804, 2504932, 2506003, 2510248, 2565323, 2567468, 2581412, 2581431, 2582867, 2587219, 2592095, 2592122, 2593400, 2596634, 2598166, 2598624, 2606956, 2623923, 2660976, 2755033, 3170816, 3173582, 3175556, 3271913, 3285889

Distribution pattern

Distributed Nationwide including Puerto Rico.

device · product 3 of 3

Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

Z-1836-2015
Recall number
Z-1836-2015
Initiated
June 01, 2015
Classification
Class II
Status
Terminated
Quantity
147,351

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.

Code information

Lot Codes for Model CTS02: 362394, 420607, 428114, 429863, 459230, 459592, 459597, 459960, 459990, 461060, 461694, 465212, 466767, 467172, 468490, 469533, 469538, 469539, 469540, 469955, 469956, 469963, 470140, 470614, 471021, 471067, 471079, 471092, 471102, 471109, 471126, 471131, 471135, 471895, 472125, 473040, 473260, 473293, 474004, 474015, 474035, 474324, 474338, 474340, 474476, 475171, 475465, 475617, 476151, 476173, 476200, 476259, 476272, 476277, 476989, 477306, 477315, 478318, 478338, 478339 478668, 479821, 479828, 480663, 480677, 480682, 480684, 481607, 481808, 481951, 481960, 481968, 483554, 483918, 483922, 483926, 483953, 483963 484011, 484027, 484032, 485218, 485511, 485557, 485567, 485591, 485622, 485656, 485660, 486107, 486138, 486143, 486209, 486253, 486800, 487210, 489255, 489651, 489704, 489738, 489745, 489957, 489958, 489962, 489979, 490076, 490086, 490864, 491163, 491256, 600325, 600929, 601012, 601925, 601982, 603277, 609051, 1786420, 1825271, 1891296, 2027905, 2163528, 2171826, 2175866, 2208579, 2222389, 2271560, 2279303, 2315316, 2954381, 2954628, 2954637, 2954778, 2957110, 2957134, 2958233, 2958246, 2969207, 2969426, 2969662, 2971689, 2972095, 2973798, 2974887, 2975148, 2975549, 2978669, 2978885, 2978892, 2980457, 2980834, 2983706, 2984021, 2984032, 2987284, 2987526, 2987896, 2989769, 2991263, 2993610, 2994626, 2995924, 2999738, 3002060, 3005909, 3018096, 3018650, 3020166, 3020757, 3021385, 3024073, 3026984, 3028690, 3028730, 3031396, 3031995, 3034204, 3037138, 3039352, 3040004, 3042988, 3043284, 3047352, 3047368, 3052859, 3054151, 3056633, 3056646, 3058219, 3059896, 3061761, 3065444, 3067448, 3070389, 3070391, 3072732, 3072745, 3075949, 3078655, 3081506, 3082044, 3083550, 3083597, 3085192, 3086485, 3086492, 3089009, 3091458, 3093279, 3096393, 3099949, 3184750, 3185474, 3186015, 3187181, 3187989, 3190002, 3190820, 3192550, 3193913, 3195683, 3198508, 3200845, 3201425, 3203415, 3204394, 3206304, 3207173, 3209437, 3210285, 3212965, 3214734, 3215952, 3217550, 3222005, 3224973, 3226077, 3231623, 3232298, 3234278, 3235296, 3286925, 3287266, 3290012, 3291855, 3291864 Lot Codes for Model CTS22: 362394, 365226, 419887, 429863, 459960, 469533, 469538, 469539, 469540, 471038, 471895, 472125, 475171, 476259, 481709, 481951, 481965, 481971, 483578, 483963, 484002, 484032, 485506, 486148, 486800, 487212, 487954, 489255, 489957, 490153, 603981, 1742132, 2171826, 2271563, 2295535, 3180274, 3180699, 3180702, 3185379, 3187970, 3190574, 3193160, 3195339, 3200866, 3209060, 3212544, 3215947, 3218572, 3221995, 3225575, 3226065, 3233621, 3288568, 3288575

Distribution pattern

Distributed Nationwide including Puerto Rico.