MED-RX Single Use REF 54-3680R — Class II medical device recall Z-0595-2016
Terminated recall by Benlan, Inc., reported 2016-01-13. The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size.
| Recall number | Z-0595-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Benlan, Inc., Oakville, N/A, Canada |
| Recall initiated | 2015-12-11 |
| Classified | 2016-01-06 |
| Reported by FDA | 2016-01-13 |
| Terminated | 2016-10-31 |
| Countries outside the US | CA |
| Quantity | 120 units |
| Lot numbers | 114842, 116433, 118251 |
| Model numbers | 54-3680R |
Product
MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, Made in Canada, Benton, Oakville, Ontario, Canada
Reason for recall
The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size.
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-0595-2016. 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.