EndoVive Safety PEG Kit — Class II medical device recall Z-1551-2026
Ongoing recall by Boston Scientific Corporation, reported 2026-03-18, distributed nationwide. Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile s
| Recall number | Z-1551-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2026-02-10 |
| Classified | 2026-03-11 |
| Reported by FDA | 2026-03-18 |
| Distributed | Nationwide (US) |
| Quantity | 806 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 08714729880387, 08714729880394 |
| Lot numbers | 37435462, 37435463, 37514809, 37522541, 37525231, 37528545, 37536562, 37536563, 37536564, 37546840, 37546847, 37546849, 37546850, 37550500, 37583642, 37592036, 37731897, 37732292 |
Product
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;
Reason for recall
Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit.
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-1551-2026. 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.