[Recalled] 10 GAUGE DRILL, CODE INTVM-DRL — Products labeled as sterile were distributed, but may not have been sterilized | FDA 2021-03-22
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | 10 GAUGE DRILL, CODE INTVM-DRL |
|---|---|
| Brand / manufacturer | BIOPSYBELL S.R.L. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1649-2021 |
| Country of notice | Italy |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 22 March 2021 |
| EAN / barcode | 20102486 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Products labeled as sterile were distributed, but may not have been sterilized.
This Class II recall concerns device products distributed in Italy and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from BIOPSYBELL S.R.L.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.