Recall events
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Event 75367
Event summary
Timeline bucket September 23, 2016
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Merit Medical Systems, 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
5 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 5
Fluid Management Set. Catalog Number K08-MP5159A
Z-0631-2017
Recall number Z-0631-2017
Initiated September 23, 2016
Classification Class II
Status Terminated
Quantity 178 units
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
compromised sterile barrier
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-0631-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45761]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
Code information Lot Number: H996433
Distribution pattern Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.
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[23661]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 5
Manifold Kit. Catalog Number K09-11867AP
Z-0632-2017
Recall number Z-0632-2017
Initiated September 23, 2016
Classification Class II
Status Terminated
Quantity 40 units
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
compromised sterile barrier
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-0632-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38796]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
Code information Lot Number: H996495
Distribution pattern Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.
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[20002]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 5
Waste Management Kit. Catalog Number K10-04381AP
Z-0633-2017
Recall number Z-0633-2017
Initiated September 23, 2016
Classification Class II
Status Terminated
Quantity 30 units
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
compromised sterile barrier
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-0633-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21269]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
Code information Lot Number: H996569
Distribution pattern Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.
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[25695]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 5
Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G
Z-0634-2017
Recall number Z-0634-2017
Initiated September 23, 2016
Classification Class II
Status Terminated
Quantity 130 units
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
compromised sterile barrier
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-0634-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51243]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
Code information Lot Number: H996490
Distribution pattern Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.
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[19994]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 5
Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
Z-0635-2017
Recall number Z-0635-2017
Initiated September 23, 2016
Classification Class II
Status Terminated
Quantity 53 units
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
compromised sterile barrier
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-0635-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[10521]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
Code information Lot Numbers: H992344 and H996476
Distribution pattern Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.
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[23668]
FDA event record
· Exact recall-number query on openFDA
