{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "218198", "product_res_number": "Z-1427-2026", "event_date_initiated": "2026-01-21", "event_date_posted": "2026-02-17", "recall_status": "Open, Classified", "res_event_number": "98295", "product_code": "NEU", "k_numbers": [ "K231579", "K253888" ], "product_description": "MOLLI 2 System\nSystem includes:\nMM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker\nUDI (GTIN): 00850024195028\n\nMS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker\nUDI (GTIN): 00850024195134\n\nMP2001 - MOLLI 2 Wand\nUDI (GTIN): 00850024195141\n\nMP2015A - MOLLI OncoPen\nUDI (GTIN): 00850024195219\n\nMT2001 - MOLLI 2 Tablet\nUDI (GTIN): 00850024195158\n\nThe MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.", "code_info": "Catalog Number: MM1000 (Pack of 10)\nUDI (GTIN): 00850024195028\nSerial Numbers:\n23-0350\t24-0118\t24-0289\t24-0290\t24-0291\t24-0472\t24-0473\t24-0474\t24-0534\t24-0535\t24-0536\t24-0658\t24-0660\t24-0697\t25-0020\t25-0021\t25-0022\t25-0160\t25-0161\t25-0162\n25-0353\t25-0354\t25-1057\t25-1058\t25-1060\t25-1087\t23-0003\t23-0046\t23-0057\t23-0062\t23-0125\t23-0126\t23-0129\t23-0176\t23-0177\t23-0179\t23-0413\t23-0414\t24-0413\t\n\n\nCatalog Number: MS-00009 (Pack of 10)\nUDI (GTIN):00850024195134 \nSerial Numbers:\n22-0130\t23-0022\t23-0130\t23-0178\t24-0035\t24-0117\t24-0225\t24-0235\t24-0236\t24-0659\t24-0696\t24-0719\t25-0251\t25-0252\n\n\nCatalog Number: MP2001\nUDI (GTIN): 00850024195141\nSerial Numbers:\n16\t18\t29\t30\t32\t43\t49\t54\t60\t62\t66\t77\t80\t81\t84\t85\t92\t93\t100\t101\n114\t115\t138\t155\t158\t160\t163\t164\t174\t180\t181\t182\t184\t186\t190\t199\t202\t203\t216\t217\n218\t220\t221\t222\t225\t226\t227\t228\t229\t230\t231\t232\t234\t235\t236\t237\t238\t239\t240\t241\n242\t243\t244\t245\t246\t249\t250\t251\t252\t253\t254\t255\t256\t257\t258\t259\t260\t261\t262\t263\n264\t265\t266\t267\t268\t269\t270\t271\t273\t274\t275\t276\t277\t278\t279\t280\t281\t282\t283\t284\n285\t286\t287\t288\t290\t291\t292\t293\t294\t295\t296\t297\t298\t299\t300\t301\t302\t303\t304\t305\n307\t310\t311\t313\t315\t316\t317\t318\t319\t320\t321\t322\t323\t324\t326\t327\t328\t329\t330\t331\n332\t333\t334\t335\t336\t337\t338\t339\t340\t341\t342\t343\t344\t345\t346\t347\t348\t349\t351\t352\n353\t354\t355\t356\t357\t358\t359\t360\t361\t362\t363\t364\t365\t366\t367\t368\t369\t370\t371\t372\n373\t374\t375\t376\t377\t378\t379\t380\t381\t382\t383\t384\t385\t386\t387\t388\t389\t390\t391\t392\n393\t394\t395\t396\t397\t398\t399\t400\t401\t402\t403\t405\t406\t408\t409\t410\t411\t412\t413\t414\n415\t416\t417\t418\t419\t420\t421\t422\t423\t424\t425\t426\t427\t428\t429\t430\t431\t432\t433\t434\n435\t436\t437\t438\t439\t440\t441\t442\t443\t444\t446\t447\t448\t449\t450\t451\t453\t454\t455\t456\n457\t458\t460\t461\t464\t465\t466\t467\t468\t469\t470\t471\t472\t473\t474\t475\t476\t477\t478\t479\n480\t481\t482\t483\t484\t485\t486\t487\t488\t489\t490\t491\t492\t493\t494\t495\t496\t497\t498\t499\n500\t501\t502\t503\t504\t505\t506\t507\t508\t509\t510\t511\t512\t513\t514\t515\t516\t517\t518\t519\n520\t521\t522\t523\t524\t525\t526\t527\t528\t529\t530\t531\t532\t533\t534\t535\t536\t537\t538\t539\n540\t541\t542\t543\t544\t545\t546\t547\t548\t549\t550\t551\t552\t553\t554\t555\t556\t558\t559\t560\n561\t562\t563\t564\t565\t566\t567\t568\t569\t570\t571\t573\t574\t575\t576\t577\t578\t580\t581\t583\n584\t585\t586\t587\t588\t589\t590\t592\t601\t605\t606\t607\t608\t609\t610\t611\t612\t613\t614\t615\n616\t617\t618\t619\t620\t621\t622\t623\t624\t625\t626\t627\t628\t629\t630\t631\t632\t633\t634\t635\n636\t637\t638\t639\t640\t641\t644\t645\t646\t647\t651\t652\t653\t654\t655\t656\t657\t658\t659\t660\n661\t662\t663\t666\t670\t674\t675\t730\t742\t743\t745\t747\t750\t751\t752\t753\t754\t755\t756\t757\n758\t763\t764\t765\t766\t767\t768\t769\t772\t773\t775\t776\t777\t780\t782\t783\t784\t785\t786\t787\n788\t929\t930\t940\t959\t973\t976\t981\t982\t984\t986\t988\t990\t995\t997\t998\t1001\t1003\t1004\t1005\n1006\t1008\t1009\t1014\t1015\t1016\t1092\t\t\t\t\t\t\t\t\t\t\t\t\t\n\nCatalog Number: MP2015A\nUDI (GTIN): 00850024195219\nSerial 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Number: MT2001\nUDI (GTIN): 00850024195158\nSerial 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"firm_fei_number": "2936485", "recalling_firm": "Stryker Corporation", "address_1": "5900 Optical Ct", "city": "San Jose", "state": "CA", "postal_code": "95138-1400", "additional_info_contact": "Ashley Cupples\n707-530-1457", "reason_for_recall": "Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures.", "root_cause_description": "Under Investigation by firm", "action": "On 01/21/2026, the firm sent via USPS certified mail an \"URGENT: Medical Device Recall\" Letter to customers informing them that Stryker has updated the MOLLI 2 System Instructions for Use (IFU) following two Medical Device Reports (MDRs) submitted to the FDA. These reports involved patient injuries associated with MOLLI marker dislodgement or dislocation due to magnetic attraction from magnetized surgical tools. The updated IFU now includes an additional warning that using magnetized surgical tools in close proximity to the marker during localization may lead to marker dislodgement.\n\nCustomers are instructed to:\n1. Inform individuals within their organization who need to be aware of this warning statement.\n2. Review Attachment A regarding the warning statement that will be added to the IFU. Stryker estimates the updated IFUs to be released by 28FEB2026. No product return is required.\n3. Complete Attachment B, Business Reply Form (page 4), as an acknowledgement of this notice and return the completed form via email to EndoRecall@Stryker.com. Response is required.\n4. If customers have further distributed product, complete the table in Attachment B, Business Reply Form (page 4) and return the completed form via email to EndoRecall@Stryker.com.\n5. Maintain awareness of this communication internally.\n\nFor questions - contact Endorecall@stryker.com or Stryker Customer Service at 800-624-4422.", "product_quantity": "5,864", "distribution_pattern": "Worldwide - U.S. Nationwide distribution including in the states of AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY. The countries of Canada, Singapore, Panama, Jamaica, and Cayman Islands.", "openfda": { "k_number": [ "K170026", "K240527", "K053518", "K090547", "K253761", "K183503", "K062528", "K233639", "K072219", "K253888", "K201863", "K161021", "K132708", "K212158", "K082278", "K010348", "K180443", "K100994", "K203097", "K232615", "K231468", "K180640", "K133697", "K042296", "K111895", "K193189", "K072216", "K231579", "K103417", "K210752", "K050384", "K232865", "K063193", "K081085", "K223107", "K113202", "K040706", "K121113", "K090501", "K023450", "K153189", "K023694", "K132463", "K212882", "K040990", "K192771", "K141356", "K234149", "K070436", "K143484", "K083006", "K102768", "K251748", "K121964", "K050090", "K072913", "K183400", "K230836", "K102506", "K221961", "K152070", "K111692", "K130537", "K080698", "K152510", "K060769", "K011856", "K033447", "K171767", "K170905", "K210600", "K251989", "K151998", "K093473", "K170803", "K090581", "K173587", "K130763", "K123911", "K141722", "K180061", "K140835", "K181692", "K243642", "K152586", "K020276", "K093064", "K192371", "K190689", "K013413", "K014148", "K073095", "K081170", "K241762", "K012955", "K131654", "K142198", "K063238", "K051421", "K182082", "K240429", "K181007", "K190932", "K240042", "K042341", "K252892", "K222832", "K031938", "K180621", "K102608" ], "registration_number": [ "3020733550", "3008706707", "1721676", "1037905", "3012345110", "2951215", "3018024590", "3014579161", "3013649990", "1721504", "3036009309", "1222780", "3010083866", "2936485", "2020394", "1647149", "3030733800", "9680340", "3033536844", "2032338", "1211566", "3005160949", "3038503932", "9617429", "2135401", "3018094310", "3009905888", "3015225571", "1054811", "3009656988", "3005636544", "3035366890", "3009192245", "3011245468", "3009039068", "3014680735", "3011683674", "3010813819", "3000126629", "3013875526", "3019807891", "3009649442", "3014090621", "1625425", "3033589330", "3015542154", "3016678045", "3004111573", "1000393132", "1928237", "3010339638", "2029275", "3008236846", "3009609358", "3013176080", "3007305589", "3015924373", "1020279", "3007366790", "1319660", "1222140", "1226183", "3026851515", "3015309643", "1220477", "3015439135", "3030927217", "1000486410", "3008492462", "3007738736", "3008992312", "1018233", "1825034", "3021008900", "1064858", "3011162972", "3021179744", "3006950086", "3007055279", "3009077524", "3014653199", "3012536737", "3002907620", "1835568", "1724474", "2134494", "3012644426", "3006082230", "3006981798", "3008627763", "3004636440", "3013012623", "1450662", "3015207155", "3014967969", "2022435", "3007200016", "3004904811", "1417485", "1644312", "3013557562", "3007185216", "2183744" ], "fei_number": [ "1000114185", "3020733550", "3008706707", "1721676", "1037905", "3012345110", "3018024590", "3014579161", "3013649990", "1721504", "3036009309", "3003367650", "3002807584", "3010083866", "2936485", "2020394", "3030733800", "3033536844", "1000120743", "1000221492", "1211566", "3005160949", "3038503932", "3018094310", "3009905888", "3015225571", "3009656988", "3005636544", "3035366890", "3009192245", "3011245468", "3009039068", "3014680735", "3011683674", "3010813819", "3000126629", "3013875526", "3019807891", "1000136478", "3009649442", "3014090621", "1625425", "3033589330", "3015542154", "3016678045", "3004111573", "1000393132", "1928237", "3010339638", "3008236846", "3009609358", "3013176080", "3003295907", "3007305589", "3015924373", "1020279", "1000117748", "1000121130", "3002757549", "3026851515", "3015309643", "1220477", "1000306431", "3015439135", "3030927217", "1000486410", "3008492462", "1000434163", "3007738736", "3008992312", "1018233", "3008397795", "1825034", "3021008900", "3007282753", "3011162972", "3021179744", "3006950086", "3007055279", "3009077524", "3014653199", "3012536737", "3002907620", "3003094851", "3002619738", "3012644426", "3006082230", "3006981798", "3008627763", "3004636440", "3013012623", "1450662", "3015207155", "3014967969", "2022435", "3007200016", "3004904811", "1417485", "1000306139", "3001237677", "3013557562", "3007185216", "2183744" ], "device_name": "Marker, Radiographic, Implantable", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4300", "device_class": "2" } } ] }