TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for… — Class II medical device recall Z-2539-2016
Terminated recall by TYRX Inc., reported 2016-08-24, distributed nationwide. TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not ade
| Recall number | Z-2539-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TYRX Inc., Monmouth Junction, NJ, United States |
| Recall initiated | 2016-06-29 |
| Classified | 2016-08-15 |
| Reported by FDA | 2016-08-24 |
| Terminated | 2017-12-12 |
| Distributed | Nationwide (US) |
| Quantity | 3,460 units |
| Lot numbers | 15F18607, 15F30614, 15F30614-A, 15G14620, 15H10630, 15J29647, 15K29659, 16B05695, 16C03706 |
| Model numbers | CMRM3122, CMRM3133 |
Product
TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Reason for recall
TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
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-2539-2016. 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.