Recall archive / FDA device enforcement
DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.09 — FDA record Z-0575-2023
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 3, 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
- DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.09
- Reason
- DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
- Classification
- Class II
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 42 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0575-2023
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 | Lot Numbers: Lot 57391516 exp 11/1/2024; Lot 57749549 exp 8/1/2024 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 21, 2022
- Recall initiation date
- Nov 3, 2022
- Center classification date
- Dec 15, 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.