FDA Device recall Z-1671-2013
RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation Rigifl…
- FDA Device
- Class III
- terminated
- Published 2013-07-17
On 2013-07-17 the FDA classified a Class III recall of RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation Rigifl… by Boston Scientific, citing product labeled with incorrect expiration date.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1671-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-05-28 |
| Published | 2013-07-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.
Reason
Product labeled with incorrect expiration date.
Identifiers
| code_info | Lot/Batch Number: 091541 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1671-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.