Recall archive / FDA device enforcement
Surgical Suture Kit — FDA record Z-1132-2022
Reported terminated
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 22, 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
- Surgical Suture Kit
- Reason
- There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
- Classification
- Class II
- Recalling firm
- Stradis Healthcare
- Quantity
- 7340 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-1132-2022
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 | Part Number: ZZ-0958; Primary DI Number: M752ZZ09580; Lot Numbers: 213639474, 212957814, 212675717 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Distribution to NC.
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
- Jun 1, 2022
- Recall initiation date
- Apr 22, 2022
- Center classification date
- May 25, 2022
- Termination date
- Sep 22, 2026
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.