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GRAFTSITE
SUMMIT MEDICAL LIMITED · Model D201045 · UDI-DI 15060238201145
1
510(k) clearances
5,156
Adverse events (5 deaths)
220
Recalls
81
Facilities
Description
GRAFTSITE Delivery Assistance Device
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-27 | Becton Dickinson & Company | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identifi |
| 2026-04-27 | Becton Dickinson & Company | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identifi |
| 2026-04-27 | Becton Dickinson & Company | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identifi |
| 2026-04-27 | Becton Dickinson & Company | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identifi |
| 2026-04-27 | Becton Dickinson & Company | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identifi |
| 2026-04-27 | Becton Dickinson & Company | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identifi |
| 2026-04-27 | Becton Dickinson & Company | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identifi |
| 2026-04-27 | Becton Dickinson & Company | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identifi |
| 2026-04-27 | Becton Dickinson & Company | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identifi |
| 2026-04-27 | Becton Dickinson & Company | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identifi |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.