{"url_path":"/fda/device/recalls/Z-2204-2026","section_key":"summary","section_title":"DEVICE Recall: Becton, Dickinson and Company — Swan-Ganz Pacing Catheter, Models: D200F7;","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-08","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2204-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Becton, Dickinson and Company"},"word_count":198,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2204-2026\n\n**Recalling firm:** Becton, Dickinson and Company\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-08\n**Report date:** 2026-05-27\n\n## Product\nSwan-Ganz Pacing Catheter, Models: D200F7;\n\n## Reason\nCatheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.\n\n## Affected lots\nModel-UDI-DI/Lot(Expiration): D200F7-00690103147315/66725358(7/2/2027)\n\n## Distribution\nWorldwide - US Nationwide distribution including in the states of TX, SC, CT, GA, VA, MO, NM, UT, NJ, CA, FL, PA, IN, TN, WA, KY, MD, WV, MI, MA, NC, MN, NY, AZ, AL, LA, CO, OK, HI, MS, IL, OH, NE, DC, KS, NV, WI, SD, IA, AR, ID, OR, WY, MT, RI, VT, DE, AK, NH, ND, ME, PR and the countries of Japan, Brazil, Colombia, Australia, New Zealand, Poland, Czech Republic, South Africa, Mauritius, Germany, Israel, Iran, Slovakia, Switzerland, Slovenia, Bulgaria, Cyprus, Saudi Arabia, United Arab Emirates (UAE), Kuwait, Malta, Bahrain, Qatar, Hungary, Morocco, Romania, Lebanon, Tunisia, Oman, Turkey, Austria, Belgium, Luxembourg, France, Netherlands, Italy, Spain, Canary Islands, Portugal, United Kingdom, Northern Ireland, Ireland, Denmark, Sweden, Iceland, Norway, Estonia, Finland, Greece, Chile, Puerto Rico, Canada."}