Recall archive / FDA device enforcement
Swan-Ganz Pacing Catheter, Models: D200F7; — FDA record Z-2204-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 8, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Swan-Ganz Pacing Catheter, Models: D200F7;
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Becton, Dickinson and Company
- Quantity
- 53
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2204-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model-UDI-DI/Lot(Expiration): D200F7-00690103147315/66725358(7/2/2027) |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- May 27, 2026
- Recall initiation date
- Apr 8, 2026
- Center classification date
- May 15, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.