US Food and Drug Administration, The Government of USA has issued the following enforcement report: Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8; Catheters 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. Product Quantity: 589,223. Recall Number: Z-2202-2026.

Code Information: Model/UDI-DI/Lot(Expiration): 131F7P/00690103000412/65902900(8/1/2026), 65902901(8/3/2026), 65910728(8/2/2026), 65910729(7/29/2026), 65910730(7/27/2026), 65910731(7/25/2026), 65910732(7/26/2026), 65910735(7/30/2026), 65910736(8/24/2026), 65910737(7/31/2026), 65916927(8/3/2026), 65916928(8/6/2026), 65916929(8/7/2026), 65916930(8/8/2026), 65916931(8/9/2026), 65916932(8/22/2026), 65916933(8/23/2026), 65944791(8/20/2026), 65944792(8/21/2026), 65955857(9/9/2026), 65955858(9/17/2026), 65955859(9/26/2026), 65955860(9/27/2026), 65973739(9/5/2026), 65973740(9/6/2026), 65973741(9/7/2026), 65973742(9/10/2026), 65988571(9/28/2026), 65997478(9/16/2026), 65997479(9/17/2026), 65997481(9/19/2026), 65997482(9/20/2026), 66010504(9/10/2026), 66010505(9/11/2026), 66010506(9/12/2026), 66010507(9/13/2026), 66010508(9/14/2026), 66023074(9/30/2026), 66033088(10/5/2026), 66048930(10/9/2026), 66057629(10/6/2026), 66057630(10/8/2026), 66057944(10/15/2026), 66057945(10/17/2026), 66061552(10/24/2026), 66074999(10/4/2026), 66075318(11/19/2026), 66104892(10/21/2026), 66104893(10/22/2026), 66104894(10/23/2026), 66104895(11/13/2026). Classification: Class II. Event Details Event ID: 98603.

Voluntary /Mandated: Voluntary: Firm initiated. Product Type: Devices. Status: Ongoing.

Distribution Pattern: Worldwide - 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. Recalling Firm: Becton, Dickinson and Company17200 Laguna Canyon RdIrvine, CA 92618-5403United States. Recall Initiation Date: April 8, 2026.

Center Classification Date: May 15, 2026.