Vitagel — Class II medical device recall Z-1353-2015
Terminated recall by Orthovita, Inc., dBA Stryker Orthobiologics., reported 2015-04-08, distributed nationwide. Several shipments of Vitagel product (a surgical hemostat) required to be stored at 2 -8 degrees Celsius (C) w
| Recall number | Z-1353-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthovita, Inc., dBA Stryker Orthobiologics., Malvern, PA, United States |
| Recall initiated | 2015-02-26 |
| Classified | 2015-03-30 |
| Reported by FDA | 2015-04-08 |
| Terminated | 2015-07-28 |
| Distributed | Nationwide (US) |
| Quantity | 274 |
| Lot numbers | A1406053, A1407037, A1407061, A1410055, A1412010, A1412076, A1501033 |
| Expiration dates | 2017-02-28 |
Product
Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Reason for recall
Several shipments of Vitagel product (a surgical hemostat) required to be stored at 2 -8 degrees Celsius (C) were not delivered to customers within the validated delivery time.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1353-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.