United StatesSwan‑Ganz catheters — including the listed Swan‑Ganz models (131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8), Swan‑Ganz Jr models (SGPT54, SGPT64P, SGPT755P), and Swan‑Ganz Pacing Catheter model D200F7 — are affected and can be identified by their model numbers and the blue proximal injectate lumen hub. They were recalled because manufacturing process and material changes may cause the proximal injectate lumen hub to leak or break, which may lead to infection, medication loss, and/or blood loss.
What's being recalled
Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8;
Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
Swan-Ganz Pacing Catheter, Models: D200F7;
Recalling firm: Becton, Dickinson and Company, Irvine, CA, United States.
How to identify it
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), 66108277(11/15/2026), 66118638(11/22/2026), 66120310(10/29/2026), 66120312(10/30/2026), 66120313(10/31/2026), 66127027(11/15/2026), 66127028(11/20/2026), 66132570(11/21/2026), 66132571(11/25/2026), 66132572(11/27/2026), 66140447(11/2/2026), 66140448(11/5/2026), 66140449(11/6/2026), 66140450(11/7/2026), 66142269(11/28/2026), 66142274(11/29/2026), 66151008(12/20/2026), 66160820(11/30/2026), 66160821(12/3/2026), 66160822(12/4/2026), 66160823(12/5/2026), 66174935(12/6/2026), 66186389(12/9/2026), 66186390(12/10/2026), 66186391(12/11/2026), 66186393(12/19/2026), 66214346(12/12/2026), 66214347(12/17/2026), 66214348(12/13/2026), 66214349(12/16/2026), 66225263(1/24/2027), 66230833(1/27/2027), 66230834(1/28/2027), 66231174(1/29/2027), 66236300(2/3/2027), 66243301(1/30/2027), 66243302(2/1/2027), 66254697(2/4/2027), 66254698(2/10/2027), 66273573(2/11/2027), 66273574(2/12/2027)…
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)