Recall archive / FDA device enforcement
Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,N... — FDA record Z-1364-2025
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 Feb 13, 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
- Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,UNIVERSAL II,SIRUS,7/CS; PACK,LAPAROTOMY,NO GOWN,10/CS; PACK,CYSTOSCOPY,PK VI,14/CS; PACK,CYSTOSCOPY,PK VI,14/CS; PACK,OB III,GRADUATED UNDERBUTTOCK,6/CS; PACK,LAVH,AURORA,4/CS. Sterile surgical drape.
- Reason
- Potential breach in pouch packaging which could lead to loss of sterility.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 1,490 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1364-2025
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 | Item No. DYNJP1020S, DYNJP1025S, DYNJP1040, DYNJP1055S, DYNJP3000, DYNJP5050, DYNJP6060S, DYNJP9120A; UDI (case): 40080196308126, 40080196308133, 40080196722892, 40080196308195, 40080196722946, 40080196753391, 40884389110295, 40080196915416; UDI (each): 10080196308125, 10080196308132, 10080196722891, 10080196308194, 10080196722945, 10080196753390, 10884389110294, 10080196915415; Lot No. 31124090044H, 31124090028F, 31124080024F, 31124080061F, 31124090029F, 31124090089F, 31124100077F, 31124090030H, 31124090054F, 31124070070F, 31124080063F, 45024090166, 31124100007F. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution.
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
- Mar 26, 2025
- Recall initiation date
- Feb 13, 2025
- Center classification date
- Mar 14, 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.