{"url_path":"/fda/device/recalls/Z-2655-2026","section_key":"summary","section_title":"DEVICE Recall: Bard Access Systems, Inc. — OTP5000\tTHORA/PARA TRAY, 5FR, NON-VALVED  UDI-DI Code: 0110885403284748    PIG1260T\tSAFE-T-CENTESIS TRAY 6FR X 16CM  UDI-DI Code: 0110885403108365    TPT1000\tTHORACENTESIS/PARACENTESIS TRAY  UDI-DI Code: 0110885403108488      The Acute Drainage devices are indicated for use in removing fluid from either the pleural or peritoneal spaces during an acute dr…","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-21","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2655-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Bard Access Systems, Inc."},"word_count":199,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2655-2026\n\n**Recalling firm:** Bard Access Systems, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-21\n**Report date:** 2026-07-08\n\n## Product\nOTP5000\tTHORA/PARA TRAY, 5FR, NON-VALVED  UDI-DI Code: 0110885403284748    PIG1260T\tSAFE-T-CENTESIS TRAY 6FR X 16CM  UDI-DI Code: 0110885403108365    TPT1000\tTHORACENTESIS/PARACENTESIS TRAY  UDI-DI Code: 0110885403108488      The Acute Drainage devices are indicated for use in removing fluid from either the pleural or peritoneal spaces during an acute drainage / aspiration procedure.\n\n## Reason\nDue to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.\n\n## Affected lots\nOTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 Lot Number: REKY3402  PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 Lot Number: REKY3397  TPT1000 THORACENTESIS/PARACENTESIS TRAY UDI-DI Code: 0110885403108488 Lot Number: REKY3386\n\n## Distribution\nWorldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium."}