Recall archive / FDA device enforcement
Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56 — FDA record Z-1751-2025
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 11, 2025. 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
- Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
- Reason
- During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
- Classification
- Class II
- Recalling firm
- LeMaitre Vascular, Inc.
- Quantity
- 65,977 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1751-2025
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 | UDI-DI: 00840663101535, 00840663101542. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56. Lots not expired with the following prefix: POC, QPO, XPO. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Nationwide distribution. International distribution to ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECHIA, DENMARK, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONGOLIA, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORTH MACEDONIA, NORWAY, OMAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKIYE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.
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 21, 2025
- Recall initiation date
- Apr 11, 2025
- Center classification date
- May 12, 2025
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.