Recall archive / FDA device enforcement
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support — FDA record Z-0916-2022
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 Mar 8, 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
- ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
- Reason
- Pouch seals may be open, compromising sterility.
- Classification
- Class II
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 488 5-packs
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0916-2022
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 | ROTAWIRE Drive Extra Support, 5 pack, UPN: H74939463005 Individual units within 5-pack are labeled as Single, UPN: H74939463001 Batch numbers: 27630467, 27632712, 27701910, 27705926, 27749752, 27749754, 27792970 27804244, 27805109, 27806091, 27826574, 27826576, 27853736, 27853738, and 27862767 GTIN: 08714729996231 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution in the US and territories, Japan, and Canada
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Apr 20, 2022
- Recall initiation date
- Mar 8, 2022
- Center classification date
- Apr 12, 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.