{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Innsbruck",
      "state": "N/A",
      "country": "Austria",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "72575",
      "recalling_firm": "Leonhard Lang Medizintechnik GmbH",
      "address_1": "Archenweg 56",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US Distribution to the state of : FL., and to the countries of : Australia, Austria, Croatia, Czech Republic, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Malta, Norway,  Poland, Portugal, Romania, Serbia, Spain, Switzerland, Thailand, Turkey and United Arab Emirates.",
      "recall_number": "Z-0292-2016",
      "product_description": "ECG Electrodes:    50007 \u0013 Stablebase SBW55  50675 \u0013 Stablebase SBW55-15  58051 \u0013 Skintact W-60  50547 \u0013 Stablebase SBT60    Only OUS:  50476 Skintact W-60HP E3 I  58046 Skintact T-60 I Patz K920  58688 Dahlhausen 1900000440  59629 Cardionetics CN-15-W60  58789 Lessa 99.832.02  58872 EF Medica FS 50 LG  50359Ultragel FS50LG",
      "product_quantity": "16,410,800 (10,226,600 US:,  184,200 OUS)",
      "reason_for_recall": "There is a risk ECG electrodes of specific lots fail to transmit signals. There is a risk that the affected electrodes will transmit a poor signal or no signal at all before reaching the indicated expiration date.",
      "recall_initiation_date": "20151102",
      "center_classification_date": "20151118",
      "termination_date": "20171121",
      "report_date": "20151125",
      "code_info": "List of models and lot numbers - USA  Artikel No. Brand / Model Lot Nos.  Skintact W-60 (30/1200)  58051 Skintact W-60 (30/1200) 31113-0159  58051 Skintact W-60 (30/1200) 40304-0324  58051 Skintact W-60 (30/1200) 40325-0153  58051 Skintact W-60 (30/1200) 40326-0154  58051 Skintact W-60 (30/1200) 40416-0326  S&W 620  58205 S&W 620 31121-0155  58205 S&W 620 31122-0156  58205 S&W 620 31125-0159  58205 S&W 620 40730-0324  58205 S&W 620 40901-0328  58205 S&W 620 50723-0326  58205 S&W 620 50827-0329  Stable Base SBW55  50007 Stable Base SBW55 31104-0159  50007 Stable Base SBW55 31107-0321  50007 Stable Base SBW55 31108-0322  50007 Stable Base SBW55 31108-0323  50007 Stable Base SBW55 31111-0324  50007 Stable Base SBW55 31118-0325  50007 Stable Base SBW55 31119-0326  50007 Stable Base SBW55 31120-0327  50007 Stable Base SBW55 31121-0328  50007 Stable Base SBW55 31121-0329  50007 Stable Base SBW55 31122-0321  50007 Stable Base SBW55 31125-0322  50007 Stable Base SBW55 31129-0323  50007 Stable Base SBW55 31202-0324  50007 Stable Base SBW55 31203-0325  50007 Stable Base SBW55 40107-0323  50007 Stable Base SBW55 40107-0324  50007 Stable Base SBW55 40108-0325  50007 Stable Base SBW55 40109-0326  50007 Stable Base SBW55 40225-0157  50007 Stable Base SBW55 40226-0158  50007 Stable Base SBW55 40227-0151  50007 Stable Base SBW55 40227-0159  50007 Stable Base SBW55 40228-0152  50007 Stable Base SBW55 40303-0153  50007 Stable Base SBW55 40304-0154  50007 Stable Base SBW55 40304-0155  50007 Stable Base SBW55 40305-0156  Page 1 of 4  50007 Stable Base SBW55 40306-0157  50007 Stable Base SBW55 40307-0158  50007 Stable Base SBW55 40310-0159  50007 Stable Base SBW55 40311-0151  50007 Stable Base SBW55 40422-0328  50007 Stable Base SBW55 40428-0329  50007 Stable Base SBW55 40430-0321  50007 Stable Base SBW55 40505-0322  50007 Stable Base SBW55 40508-0323  50007 Stable Base SBW55 40512-0324  50007 Stable Base SBW55 40616-0152  50007 Stable Base SBW55 40618-0153  50007 Stable Base SBW55 40623-0154  50007 Stable Base SBW55 40625-0155  50007 Stable Base SBW55 40626-0156  50007 Stable Base SBW55 40630-0157  50007 Stable Base SBW55 40701-0158  50007 Stable Base SBW55 40703-0159  50007 Stable Base SBW55 40705-0151  50007 Stable Base SBW55 40708-0152  50007 Stable Base SBW55 40711-0153  50007 Stable Base SBW55 40714-0154  50007 Stable Base SBW55 40715-0155  50007 Stable Base SBW55 40717-0156  50007 Stable Base SBW55 40721-0157  50007 Stable Base SBW55 40722-0158  50007 Stable Base SBW55 40724-0159  50007 Stable Base SBW55 40725-0151  50007 Stable Base SBW55 40728-0152  50007 Stable Base SBW55 40731-0154  50007 Stable Base SBW55 40804-0155  50007 Stable Base SBW55 40805-0156  50007 Stable Base SBW55 40806-0157  50007 Stable Base SBW55 40808-0158  50007 Stable Base SBW55 40811-0159  50007 Stable Base SBW55 40812-0151  50007 Stable Base SBW55 40818-0152  50007 Stable Base SBW55 40819-0153  50007 Stable Base SBW55 40822-0154  50007 Stable Base SBW55 40825-0155  50007 Stable Base SBW55 40826-0157  50007 Stable Base SBW55 40828-0158  50007 Stable Base SBW55 40901-0159  50007 Stable Base SBW55 40902-0151  50007 Stable Base SBW55 40903-0152  50007 Stable Base SBW55 40903-0153  50007 Stable Base SBW55 40904-0154  50007 Stable Base SBW55 40908-0155  50007 Stable Base SBW55 40909-0156  50007 Stable Base SBW55 40911-0157  50007 Stable Base SBW55 40913-0158  50007 Stable Base SBW55 40925-0157  50007 Stable Base SBW55 40927-0158  50007 Stable Base SBW55 40930-0159  50007 Stable Base SBW55 41010-0323  50007 Stable Base SBW55 41013-0156  50007 Stable Base SBW55 41013-0324  50007 Stable Base SBW55 41015-0157  50007 Stable Base SBW55 41015-0325  50007 Stable Base SBW55 41016-0158  50007 Stable Base SBW55 41016-0326  50007 Stable Base SBW55 41017-0159  50007 Stable Base SBW55 41020-0151  50007 Stable Base SBW55 41021-0152  50007 Stable Base SBW55 41106-0152  50007 Stable Base SBW55 41107-0153  50007 Stable Base SBW55 41111-0154  50007 Stable Base SBW55 41113-0155  50007 Stable Base SBW55 41114-0156  50007 Stable Base SBW55 41117-0157  50007 Stable Base SBW55 50609-0152  50007 Stable Base SBW55 50610-0153  50007 Stable Base SBW55 50611-0154  50007 Stable Base SBW55 50615-0155  50007 Stable Base SBW55 50617-0156  50007 Stable Base SBW55 50618-0157  50007 Stable Base SBW55 50709-0158  50007 Stable Base SBW55 50710-0159  50007 Stable Base SBW55 50714-0151  50007 Stable Base SBW55 50715-0152  50007 Stable Base SBW55 50717-0153  50007 Stable Base SBW55 50720-0154  50007 Stable Base SBW55 50818-0151  50007 Stable Base SBW55 50820-0152  50007 Stable Base SBW55 50824-0153  50007 Stable Base SBW55 50826-0154  50007 Stable Base SBW55 50827-0155  50007 Stable Base SBW55 50828-0156  50007 Stable Base SBW55 50901-0157  50007 Stable Base SBW55 50910-0153  50007 Stable Base SBW55 50914-0154  50007 Stable Base SBW55 50916-0155  50007 Stable Base SBW55 50918-0156  50007 Stable Base SBW55 50921-0157  50007 Stable Base SBW55 50923-0158  Stable Base SBW55-15  50675 Stable Base SBW55-15 40729-0153  50675 Stable Base SBW55-15 41008-0154  50675 Stable Base SBW55-15 41009-0155  50675 Stable Base SBW55-15 50213-0321  50675 Stable Base SBW55-15 50218-0322  50675 Stable Base SBW55-15 50327-0156  50675 Stable Base SBW55-15 50401-0157  50675 Stable Base SBW55-15 50403-0158  50675 Stable Base SBW55-15 50408-0159  50675 Stable Base SBW55-15 50409-0151  50675 Stable Base SBW55-15 50902-0158  50675 Stable Base SBW55-15 50903-0159  50675 Stable Base SBW55-15 50907-0151  50675 Stable Base SBW55-15 50908-0152  Stable Base SBT60  50547 Stable Base SBT60 40314-0155  50547 Stable Base SBT60 40317-0156      List of models and lot numbers - outside USA  Artikel No. Brand / Model Lot Nos.  Skintact W-60HP E3  50476 Skintact W-60HP E3 31106-0246  50476 Skintact W-60HP E3 40226-0248  50476 Skintact W-60HP E3 40307-0249  50476 Skintact W-60HP E3 40324-0247  50476 Skintact W-60HP E3 50204-0247  50476 Skintact W-60HP E3 50601-0246  Skintact T-60  58046 Skintact T-60 40312-0329  58046 Skintact T-60 40313-0321  58046 Skintact T-60 40314-0322  Skintact W-60 (30/1200)  58051 Skintact W-60 (30/1200) 31106-0152  58051 Skintact W-60 (30/1200) 31106-0153  58051 Skintact W-60 (30/1200) 31113-0158  58051 Skintact W-60 (30/1200) 31125-0158  58051 Skintact W-60 (30/1200) 31127-0151  58051 Skintact W-60 (30/1200) 31210-0321  58051 Skintact W-60 (30/1200) 31211-0322  58051 Skintact W-60 (30/1200) 31216-0158  58051 Skintact W-60 (30/1200) 31216-0159  58051 Skintact W-60 (30/1200) 40305-0325  58051 Skintact W-60 (30/1200) 40402-0159  58051 Skintact W-60 (30/1200) 40403-0151  58051 Skintact W-60 (30/1200) 40414-0324  58051 Skintact W-60 (30/1200) 40414-0325  58051 Skintact W-60 (30/1200) 40417-0327  58051 Skintact W-60 (30/1200) 40430-0156  58051 Skintact W-60 (30/1200) 40602-0326  58051 Skintact W-60 (30/1200) 40722-0328  58051 Skintact W-60 (30/1200) 40918-0321  58051 Skintact W-60 (30/1200) 41001-0326  58051 Skintact W-60 (30/1200) 41106-0329  58051 Skintact W-60 (30/1200) 41107-0321  58051 Skintact W-60 (30/1200) 41118-0325  58051 Skintact W-60 (30/1200) 41121-0327  58051 Skintact W-60 (30/1200) 50206-0327  58051 Skintact W-60 (30/1200) 50210-0328  58051 Skintact W-60 (30/1200) 50325-0155  58051 Skintact W-60 (30/1200) 50409-0329  58051 Skintact W-60 (30/1200) 50430-0329  58051 Skintact W-60 (30/1200) 50527-0322  58051 Skintact W-60 (30/1200) 50625-0322  58051 Skintact W-60 (30/1200) 50626-0323  58051 Skintact W-60 (30/1200) 50701-0324  58051 Skintact W-60 (30/1200) 50702-0325  58051 Skintact W-60 (30/1200) 50708-0327  Skintact W-60 (30/1200/4800)  58995 Skintact W-60 (30/1200/4800) 31112-0157  58995 Skintact W-60 (30/1200/4800) 40221-0153  58995 Skintact W-60 (30/1200/4800) 40430-0155  58995 Skintact W-60 (30/1200/4800) 50123-0159  58995 Skintact W-60 (30/1200/4800) 50901-0322  Skintact W-60 (30/300/1800)  59356 Skintact W-60 (30/300/1800) 31107-0154  59356 Skintact W-60 (30/300/1800) 31108-0155  59356 Skintact W-60 (30/300/1800) 31202-0154  59356 Skintact W-60 (30/300/1800) 40108-0153  59356 Skintact W-60 (30/300/1800) 40109-0154  59356 Skintact W-60 (30/300/1800) 40129-0152  59356 Skintact W-60 (30/300/1800) 40218-0159  59356 Skintact W-60 (30/300/1800) 40303-0323  59356 Skintact W-60 (30/300/1800) 40321-0151  59356 Skintact W-60 (30/300/1800) 40324-0152  59356 Skintact W-60 (30/300/1800) 40331-0158  59356 Skintact W-60 (30/300/1800) 40410-0323  59356 Skintact W-60 (30/300/1800) 40514-0327  59356 Skintact W-60 (30/300/1800) 40604-0327  59356 Skintact W-60 (30/300/1800) 40708-0322  59356 Skintact W-60 (30/300/1800) 40709-0323  59356 Skintact W-60 (30/300/1800) 40806-0329  59356 Skintact W-60 (30/300/1800) 40915-0329  59356 Skintact W-60 (30/300/1800) 41021-0329  59356 Skintact W-60 (30/300/1800) 41030-0325  59356 Skintact W-60 (30/300/1800) 41215-0329  59356 Skintact W-60 (30/300/1800) 50108-0158  59356 Skintact W-60 (30/300/1800) 50109-0159  59356 Skintact W-60 (30/300/1800) 50112-0151  59356 Skintact W-60 (30/300/1800) 50204-0326  59356 Skintact W-60 (30/300/1800) 50305-0326  59356 Skintact W-60 (30/300/1800) 50306-0327  59356 Skintact W-60 (30/300/1800) 50413-0321  59356 Skintact W-60 (30/300/1800) 50519-0327  59356 Skintact W-60 (30/300/1800) 50623-0159  59356 Skintact W-60 (30/300/1800) 50625-0151  59356 Skintact W-60 (30/300/1800) 50706-0326  59356 Skintact W-60 (30/300/1800) 50903-0326  59356 Skintact W-60 (30/300/1800) 50904-0327  Patz K920  58198 Patz K920 40219-0151  58198 Patz K920 40220-0152  58198 Patz K920 40808-0321  58198 Patz K920 50120-0157  58198 Patz K920 50917-0326  Dahlhausen 1900000440  58688 Dahlhausen 1900000440 31209-0329  58688 Dahlhausen 1900000440 40116-0151  58688 Dahlhausen 1900000440 40217-0158  58688 Dahlhausen 1900000440 40317-0323  58688 Dahlhausen 1900000440 40407-0329  58688 Dahlhausen 1900000440 40516-0328  58688 Dahlhausen 1900000440 40627-0326  58688 Dahlhausen 1900000440 40827-0327  58688 Dahlhausen 1900000440 40930-0325  58688 Dahlhausen 1900000440 41103-0326  58688 Dahlhausen 1900000440 41216-0321  58688 Dahlhausen 1900000440 50122-0158  58688 Dahlhausen 1900000440 50508-0323  58688 Dahlhausen 1900000440 50713-0329  58688 Dahlhausen 1900000440 50831-0321  Cardionetics CN-15-W60  59629 Cardionetics CN-15-W60 40115-0159  59629 Cardionetics CN-15-W60 40327-0155  59629 Cardionetics CN-15-W60 40606-0328  59629 Cardionetics CN-15-W60 41023-0321  59629 Cardionetics CN-15-W60 50119-0156  59629 Cardionetics CN-15-W60 50407-0326  59629 Cardionetics CN-15-W60 50812-0322  Lessa 99.832.02  58789 Lessa 99.832.02 40314-0097  58789 Lessa 99.832.02 40725-0093  EF Medica FS 50 LG  58872 EF Medica FS 50 LG 40307-0091  Ultragel FS50LG  50359 Ultragel FS50LG 40304-0098"
    }
  ]
}