Recall archive / FDA device enforcement
Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2 — FDA record Z-0838-2022
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 Feb 19, 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
- Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
- Reason
- Transport company failed to stop at the border for required FDA inspection.
- Classification
- Class II
- Recalling firm
- Ansell Healthcare Products LLC
- Quantity
- 74 cases
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0838-2022
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 | Model Number: 20685275 UDI Code: 00884792385244 Lot Number: 2107481604 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S.: AZ, CA, NV, TX, UT and WA O.U.S.: None
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
- Apr 6, 2022
- Recall initiation date
- Feb 19, 2022
- Center classification date
- Mar 30, 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.