{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "218707", "product_res_number": "Z-1566-2026", "event_date_initiated": "2026-02-12", "event_date_posted": "2026-03-20", "recall_status": "Open, Classified", "res_event_number": "98429", "product_code": "GEH", "k_numbers": [ "K190651" ], "product_description": "Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm)\nREF: 20402-401\nSTERILE EO. For surgical use", "code_info": "UDI: 04050147021785/\nExpanded Lots: WO471345 WO471346 WO471347 WO471348 WO471349 WO472537 WO472538 WO472539 WO472540 WO472594 WO472595 WO472596 WO472597 WO472598 WO472599 WO472600 WO472601 WO472602 WO472603 WO472617 WO472618 WO472619 WO472620 WO472621 WO472622 WO472623 WO472624 WO472625 WO472626 WO472627 WO472628 WO472629 WO472630 WO472631 WO472632 WO472633 WO472634 WO472635 WO472636 WO472642 WO472643 WO472644 WO472647 WO472648 WO472649 WO473613 WO473614 WO473615 WO473616 WO473617 WO473618 WO473619 WO473646 WO473647 WO473648 WO473649 WO473650 WO473651 WO474289 WO474290 WO474291 WO474292 WO474580 WO474581 WO474582 WO474583 WO474584 WO474585 WO474586 WO474587 WO474588 WO475359 WO475360 WO475361 WO475362 WO475363 WO475364 WO475368 WO475369 WO475370 WO475371 WO475372 WO475373 WO475374 WO475375 WO475376 WO475377 WO475378 WO475382 WO475383 WO475384 WO475385 WO475386 WO476017 WO476018 WO476019 WO476020 WO476021 WO476226 WO476227 WO476228 WO476229 WO476230 WO476231 WO476232 WO476233 WO476234 WO476235 WO476273 WO476274 WO476275 WO476690 WO476691 WO476692 WO476693 WO476694 WO476695 WO476696 WO476697 WO476698 WO477070 WO477071 WO477072 WO477073 WO477497 WO477498 WO477499 WO477500 WO477501 WO477502 WO477503 WO477504 WO477505 WO477506 WO477507 WO477508 WO477686 WO477687 WO477688 WO477689 WO477979 WO477980 WO477981 WO477982 WO477983 WO477984 WO477985 WO477986 WO477987 WO477988 WO477989 WO477990 WO478178 WO478179 WO478180 WO478181 WO478182 WO478183 WO478184 WO478185 WO478186 WO478187 WO478188 WO478952 WO478953 WO478954 WO478955 WO478957\nInitial Lots: WO461310\nWO461311\nWO461312\nWO461314\nWO461315\nWO461829\nWO461831\nWO461832\nWO461833\nWO461834\nWO461835\nWO461842\nWO461843\nWO461844\nWO461847\nWO461848\nWO462117\nWO462118\nWO462119\nWO462120\nWO462121\nWO462122\nWO462123\nWO462124\nWO462125\nWO462128\nWO462129\nWO462130\nWO462373\nWO462374\nWO462375\nWO462376\nWO462377\nWO462378\nWO462379\nWO462380\nWO462387\nWO462388\nWO462389\nWO462397\nWO462825\nWO462826\nWO462827\nWO462828\nWO462829\nWO462830\nWO462831\nWO462838\nWO462839\nWO462840\nWO462841\nWO462842\nWO462843\nWO462844\nWO462845\nWO462846\nWO462847\nWO462848\nWO462849\nWO463308\nWO463309\nWO463310\nWO463311\nWO463312\nWO463313\nWO463314\nWO463316\nWO463317\nWO463390\nWO463391\nWO463392\nWO463393\nWO463394\nWO463395\nWO463396\nWO463397\nWO463398\nWO463399\nWO463400\nWO463401\nWO463402\nWO463403\nWO463404\nWO463405\nWO463406\nWO463407\nWO463408\nWO463409\nWO464270\nWO464271\nWO464272\nWO464273\nWO464274\nWO464275\nWO464276\nWO464277\nWO464278\nWO464279\nWO464699\nWO464700\nWO464701\nWO464702\nWO464703\nWO464994\nWO464995\nWO464996\nWO464997\nWO465021\nWO465022\nWO465023\nWO465024\nWO465025\nWO465026\nWO465027\nWO465050\nWO465051\nWO465052\nWO465053\nWO465054\nWO465055\nWO465056\nWO465057\nWO465066\nWO465067\nWO465068\nWO465069\nWO465243\nWO465244\nWO465245\nWO465246\nWO465247\nWO465248\nWO465249\nWO465255\nWO465256\nWO465257\nWO465258\nWO465259\nWO465260\nWO465261\nWO465262\nWO465266\nWO465267\nWO465268\nWO465269\nWO467858\nWO467859\nWO467860\nWO467861\nWO467862\nWO467863\nWO467884\nWO467885\nWO467886\nWO468210\nWO468211\nWO468212\nWO468213\nWO468214\nWO468215\nWO468216\nWO468217\nWO468218\nWO468219\nWO468220\nWO468221\nWO468230\nWO468231\nWO468232\nWO468609\nWO468610\nWO468611\nWO468612\nWO468613\nWO468614\nWO468618\nWO468619\nWO468620\nWO468621\nWO468622\nWO468623\nWO468624\nWO468625\nWO468626\nWO468627\nWO468628\nWO468629\nWO468630\nWO468631\nWO468632\nWO468634\nWO468635\nWO468636\nWO468637\nWO468638\nWO468639\nWO468640\nWO468641\nWO468654\nWO468655\nWO468656\nWO468657\nWO468658\nWO468659\nWO468660\nWO468661\nWO468662\nWO468663\nWO468664\nWO468665\nWO468666\nWO468669\nWO468670\nWO469350\nWO469351\nWO469352\nWO469353\nWO469354\nWO469357\nWO469358\nWO469359\nWO471335\nWO471336\nWO471337\nWO471338\nWO471339\nWO471340\nWO471341\nWO471342\nWO471344\nW4468495\nW4465348\nW2469080\nW2469062\nW2469061\nW2469059\nW2469058\nW2468858\nW2465755\nW2465609\nW2463595\nW2463592\nW2463591\nW2463590\nW2463589\nW2462285\nW2462282\nW2462281\nW2462280\nW2462279\nW2459857\nW2459856\nW2459855", "firm_fei_number": "1000140388", "recalling_firm": "Erbe USA Inc", "address_1": "2225 Northwest Pkwy SE", "city": "Marietta", "state": "GA", "postal_code": "30067-8764", "additional_info_contact": "Erbe Field Action TEam\n678-483-8499 Ext. 133", "reason_for_recall": "Probes may rupture/burst during activation", "root_cause_description": "Process control", "action": "On May 5, 2026, ERBE USA issued a \"Urgent Medical Device Recall Expansion notification via E-Mail. The expansion was issued due to new lot numbers that may cause the same failure mode. The original notification was issued on Feb. 12, 2026. ERBE asked consignees to take the following actions:\n\n1. Discontinue use of the products with the affected lot numbers.\n2. Examine your inventory, remove, and quarantine any identified devices with the affected lot numbers \n3. Ensure all applicable personnel within the vicinity of device activation carefully read the content of this notification. If affected product has been transferred to a different location, please ensure that location and personnel receive a copy of this notification.\n4. Please contact Erbe at fieldaction.us@erbegroup.com or 678-483-8499, to obtain a Return Material Authorization number\n5. Please complete the Response Form and return to Erbe \n6. If you have further distributed this product, identify your locations, and forward this notification to them.\n7. Erbe requests you to report any complaints, including any instances of ruptures/bursts, to our Technical Service Department at 770-955-4400. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program.", "product_quantity": "64216 units", "distribution_pattern": "US Nationwide distribution, including Puerto Rico.", "openfda": { "k_number": [ "K970995", "K152668", "K253000", "K041783", "K161615", "K253114", "K161202", "K091721", "K170810", "K961219", "K161337", "K892237", "K914591", "K162608", "K050347", "K003811", "K211149", "K201740", "K942299", "K160273", "K881349", "K190747", "K935010", "K160669", "K173037", "K172769", "K060144", "K153541", "K242932", "K955083", "K251493", "K980668", "K061510", "K111042", "K953294", "K102360", "K955011", "K252198", "K023487", "K090978", "K944221", "K002615", "K152133", "K221897", "K810409", "K926464", "K220674", "K842959", "K060928", "K253230", "K190407", "K012214", "K021261", "K234002", "K982506", "K811390", "K031117", "K101049", "K151054", "K062896", "K181741", "K030303", "K020605", "K030838", "K032333", "K082074", 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"3002807555", "3017820152", "1719513", "3039443404", "3007829657", "3012627460", "1220477", "3004608878", "1000140327", "3007487007", "1450662", "3013283620" ], "device_name": "Unit, Cryosurgical, Accessories", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4350", "device_class": "2" } } ] }