Recall archive / FDA device enforcement
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC... — FDA record Z-2535-2023
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 Jul 7, 2023. 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
- Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648
- Reason
- Ultrasound gel mislabeled with inappropriate use.
- Classification
- Class II
- Recalling firm
- Advance Medical Designs, Inc.
- Quantity
- 117875 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2535-2023
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 | a) 20-PC424, Lot Numbers: 21109C2345; b) 20-PC448, Lot Numbers: 30371C3276; c) 20-PC548, Lot Numbers: 21088C2341, 30353C3268; d) 20-PC596, Lot Numbers: 20622C2244, 30481C3301; e) 20-PC648, Lot Numbers: 20145C2088, 20163C2097 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US, Canada, UK, Panama, Netherlands
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Sep 20, 2023
- Recall initiation date
- Jul 7, 2023
- Center classification date
- Sep 8, 2023
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.