{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216117", "product_res_number": "Z-0233-2026", "event_date_initiated": "2025-09-17", "event_date_posted": "2025-10-23", "recall_status": "Open, Classified", "res_event_number": "97614", "product_code": "FLL", "k_numbers": [ "K030580" ], "product_description": "Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers and Welch Allyn SureTemp Plus 692 (01692-200) thermometers", "code_info": "Product code 01690-200,\nSerial 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code 01690-400,\nSerial numbers\n24521201\n24521202\n24521203\n24521204\n24521205\n24521206\n24521207\n24521208\n24521209\n24521210\n24521211\n24521212\n24521213\n24521214\n24521215\n24521216\n24521217\n24521218\n24521219\n24521220\n24521221\n24521222\n24521223\n24521224\n24521225\n24521226\n24521227\n24521228\n24521229\n24521230\n24521231\n24521232\n24521233\n24521234\n24521235\n24521236\n24521237\n24521238\n24521239\n24521240\n24521241\n24521242\n24521243\n24521244\n24521245\n24521246\n24521247\n24521248\n24521249\n24521250\n24521251\n24521252\n24521253\n24521254\n24521255\n24521256\n24521257\n24521258\n24521259\n24521260\n24521261\n24521262\n24521263\n24521264\n24521265\n24521266\n24521267\n24521268\n24521269\n24521270\n24521271\n24521272\n24521273\n24521274\n24521275\n24521276\n24521277\n24521278\n24521279\n24521280\n24521281\n24521282\n24521283\n24521284\n24521285\n24521286\n24521287\n24521288\n24521289\n24521290\n24521291\n24521292\n24521293\n24521294\n24521295\n24521296\n24521297\n24521298\n24521299\n24521300\n24521301\n24521302\n24521303\n24521304\n24521305\n24521306\n24521307\n24521308\n24521309\n24521310\n24521311\n24521312\n24521313\n24521314\n24521315\n24521316\n24521317\n24521318\n24521319\n24521320\n24521321\n24521322\n24521323\n24521324\n24521325\n24521326\n24521327\n24521328\n24521329\n24521330\n24521331\n24521332\n24521333\n24521334\n24521335\n24521336\n24521337\n24521338\n24521339\n24521340\n24521341\n24521342\n24521343\n24521344\n24521345\n24521346\n24521347\n24521348\n24521349\n24521350\n25046327\n25046328\n25046329\n25046330\n25046331\n25046332\n25046333\n25046334\n25046335\n25046336\n25046337\n25046338\n25046339\n25046340\n25046341\n25046342\n25046343\n25046344\n25046345\n25046346\n25046347\n25046348\n25046349\n25046350\n25046351\n25046352\n25046353\n25046354\n25046355\n25046356\n25046357\n25046358\n25046359\n25046360\n25046361\n25046362\n25046363\n25046364\n25046365\n25046366\n25046367\n25046368\n25046369\n25046370\n25046371\n25046372\n25046373\n25046374\n25046375\n25046376\n25046377\n25046378\n25046379\n25046380\n25046381\n25046382\n25046383\n25046384\n25046385\n25046386\n25046387\n25046388\n25046389\n25046390\n25046391\n25046392\n25046393\n25046394\n25046395\n25046396\n25046397\n25046398\n25046399\n25046400\n25046401\n25046402\n25046403\n25046404\n25046405\n25046406\n25046407\n25046408\n25046409\n25046410\n25046411\n25046412\n25046413\n25046414\n25046415\n25046416\n25047330\n25047331\n25047332\n25047333\n25047334\n25047335\n25047336\n25047337\n25047338\n25047339\n25047340\n25047341\n25047342\n25047343\n25047344\n25047345\n25047346\n25047347\n25047348\n25047349\n25047350\n25047351\n25047352\n25047353\n25047354\n25047355\n25047356\n25047357\n25047358\n25047359\n25047360\n25047361\n25047362\n25047363\n25047364\n25047365\n25047366\n25047367\n25047368\n25047369\n25047370\n25047371\n25047373\n25047374\n25047375\n25047376\n25047377\n25047378\n25047379\n25047380\n25047381\n25047382\n25047383\n25047384\n25047385\n25047386\n25047387\n25047388\n25047389\n25047390\n25047391\n25047392\n25047393\n25047394\n25047395\n25047396\n25047397\n25047398\n25047399\n25047400\n25047401\n25047402\n25047403\n25047404\n25047405\n25047406\n25047407\n25047408\n25047409\n25047410\n25047411\n25047412\n25047413\n25047414\n25047415\n25047416\n25047417\n25047418\n25047419\n25047420\n25047421\n25047422\n25047423\n25047424\n25047425\n25047426\n25047427\n25047428\n25047429\n25047430\n25047431\n25047432\n25047433\n25047434\n25047435\n25047436\n25047437\n25047438\n25047439\n25047440\n25047441\n25047442\n25047443\n25047444\n25047445\n25047446\n25047447\n25047448\n25047449\n25047450\n25047451\n25047452\n25047453\n25047454\n25047455\n25047456\n25047457\n25047458\n25047459\n25047460\n25047461\n25047462\n25047463\n25047464\n25047465\n25047466\n25047467\n25047468\n25047469\n25047470\n25047471\n25047472\n25047473\n25047474\n25047475\n25047476\n25047477\n25047478\n25047479\n25047480\n25047481\n25047482\n25047483\n25047484\n25047485\n25047486\n25047487\n25047488\n25047489\n25047490\n25047491\n25047492\n25047493\n25047494\n25047495\n25047496\n25047497\n25047498\n25047499\n25047500\n25047501\n25047502\n25047503\n25047504\n25047505\n25047506\n25047507\n25047508\n25047509\n25047510\n25047511\n25047512\n25047513\n25047514\n25047515\n25047516\n25047517\n25047518\n25047519\n25047520\n25047521\n25047522\n25047523\n25047524\n25047525\n25047526\n25047527\n25047528\n25047529\n25047530\n25047531\n25047532\n25047533\n25047534\n25047535\n25047536\n25047537\n25047538\n25047539;\n\n\nProduct Code 01692-200\nSerial 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"firm_fei_number": "1417572", "recalling_firm": "Baxter Healthcare Corporation", "address_1": "1 Baxter Pkwy", "city": "Deerfield", "state": "IL", "postal_code": "60015-4625", "additional_info_contact": "Customer Service\n800-422-9837", "reason_for_recall": "Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection.", "root_cause_description": "Process control", "action": "Beginning September 17, 2025, firm notified impacted distributors via Medical Device Recall letters. Customers were instructed to return any affected product and submit a request for replacements. Distributors were instructed to notify their end users via a provided Important Product Information Letter.\n\nFor general questions regarding this action, please contact Welch Allyn technical service at 800-535-6663.\nSelect the following sequence of options: 2 (technical support), 1(English), 1 (physical exam devices), 3 (thermometry), between the hours of 8:00 AM and 8:00 PM Eastern Time, Monday through Friday.", "product_quantity": "5209", "distribution_pattern": "Distribution US nationwide, Canada and Colombia.", "openfda": { "k_number": [ "K021048", "K896779", "K854800", "K100495", "K172427", "K201977", "K121428", "K180387", "K170662", "K210565", "K210937", "K213485", "K041056", "K132514", "K214077", "K192210", "K031958", "K844124", "K821833", "K850244", "K112703", "K771995", "K964605", "K202009", "K230298", "K202481", "K182667", "K152690", "K103680", "K830592", "K771996", "K971866", "K974195", "K930930", "K983355", "K033082", "K051873", "K872527", "K970271", "K020471", 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