Recall archive / FDA device enforcement
HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783, — FDA record Z-0516-2023
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, 2022. 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
- HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783,
- Reason
- Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
- Classification
- Class II
- Recalling firm
- Stradis Medical, LLC dba Stradis Healthcare
- Quantity
- 5 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0516-2023
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 (case) H65857027831, UDI/DI (kit)M75257027830, Serial/Lot Numbers: 22234489305 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US nationwide distribution, and 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
- Dec 21, 2022
- Recall initiation date
- Nov 2, 2022
- Center classification date
- Dec 14, 2022
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.