CLASS II Device recall · Reported 1 Jul 2015 · FDA Enforcement Report

Optical Access System recalled by Stryker Sustainability

Stryker Sustainability Solutions is recalling Optical Access System, distributed nationwide in the US. The recall was initiated on 1 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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

Quantity recalled147,351

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1835-2015
FDA event ID: 71394
Recalling firm: Stryker Sustainability Solutions, Tempe, AZ
Classification: Class II
Status: Terminated
Recall initiated: 1 Jun 2015
FDA classified: 25 Jun 2015
Reported: 1 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

1 Jun 2015	Recall initiated by company
25 Jun 2015	Classified by FDA	+24 days
1 Jul 2015	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

Distributed Nationwide including Puerto Rico.

Nationwide Puerto Rico

Questions about this recall

Is Optical Access System recalled?

Yes. Stryker Sustainability Solutions recalled Optical Access System on 1 Jun 2015. The recall is Class II and its status is Terminated. Recall number Z-1835-2015.

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

Distributed Nationwide including Puerto Rico.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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