Recall events
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Event 65397
Event summary
Timeline bucket May 30, 2013
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Terumo Medical Corporation
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
2 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 2
Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature.
Z-1611-2013
Recall number Z-1611-2013
Initiated May 30, 2013
Classification Class II
Status Terminated
Quantity 20 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
incorrectly labeled
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Error in labeling
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1611-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[37070]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical devices were incorrectly labeled with extended expiration dates.
Distribution pattern 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[12292]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 2
Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing a catheter through the skin into a vein or artery.
Z-1612-2013
Recall number Z-1612-2013
Initiated May 30, 2013
Classification Class II
Status Terminated
Quantity 550 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
incorrectly labeled
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Error in labeling
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1612-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20180]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical devices were incorrectly labeled with extended expiration dates.
Distribution pattern 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[9536]
FDA event record
· Exact recall-number query on openFDA
