Glow 'N Tell 20 cm Tape: 1100-00 — Class II medical device recall Z-1055-2013
Terminated recall by LeMaitre Vascular, Inc., reported 2013-04-10, distributed nationwide. Devices were not sealed correctly during the manufacturing process, and the sterility of these products have b
| Recall number | Z-1055-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LeMaitre Vascular, Inc., Burlington, MA, United States |
| Recall initiated | 2013-03-18 |
| Classified | 2013-04-04 |
| Reported by FDA | 2013-04-10 |
| Terminated | 2014-12-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 13,560 |
| Reason classes | sterility |
Product
Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
Reason for recall
Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
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-1055-2013. 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.