Recall events
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Event 74672
Event summary
Timeline bucket June 29, 2016
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording TYRX Inc.
Dossier provenance
Source snapshots represented here
openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Complete imported group
Every recalled product in this event
3 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 3
TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Z-2539-2016
Recall number Z-2539-2016
Initiated June 29, 2016
Classification Class II
Status Terminated
Quantity 3460 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2539-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[44308]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
Code information model number CMRM3122 lot number 15F30614 15F30614-A 15H10630 15K29659 16B05695 model number CMRM3133 lot number 15F18607 15G14620 15J29647 16C03706
Distribution pattern US Nationwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[23068]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 3
TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Z-2540-2016
Recall number Z-2540-2016
Initiated June 29, 2016
Classification Class II
Status Terminated
Quantity 2993 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2540-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[44312]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
Code information model number CMRM6122 lot number 16E03727 16E05728 model number CMRM6133 lot number 16E02726 16E06729
Distribution pattern US Nationwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[23083]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 3
TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Z-2541-2016
Recall number Z-2541-2016
Initiated June 29, 2016
Classification Class II
Status Terminated
Quantity 194 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2541-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27135]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
Code information model number NMRM6122 lot number 16E03727 16E05728 model number NMRM6133 lot number 16E02726 16E09730
Distribution pattern US Nationwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[20550]
FDA event record
· Exact recall-number query on openFDA
