Recall archive / FDA device enforcement
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041 — FDA record Z-0370-2022
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 Nov 2, 2021. 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
- SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
- Reason
- Potential for open packaging seals compromising the sterility of the surgical gowns
- Classification
- Class II
- Recalling firm
- Cardinal Health
- Quantity
- 231,219 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0370-2022
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 | Lot Numbers: 20MJQ001 20MJQ002 21AJQ001 21AJQ002 21AJQ003 21AJQ004 21AJQ005 21AJQ006 21BJQ001 21BJQ002 21CJQ001 21DJQ001 21DJQ002 21DJQ003 21EJQ001 21EJQ002 21EJQ003 21EJQ004 21FJQ001 21FJQ002 21FJQ003 21GJQ001 21GJQ002 21HJQ001 21HJQ002 21HJQ003 21HJQ004 21HJQ005 21HJQ006 21JJQ001 21JJQ002 21JJQ003 UDI: 50885380172494 (cs) 10885380172496 (ea) |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
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
- Dec 22, 2021
- Recall initiation date
- Nov 2, 2021
- Center classification date
- Dec 10, 2021
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.