Recall events
/
Event 97149
Event summary
Timeline bucket June 11, 2025
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording AVID Medical, 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
24 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 24
LAPAROSCOPIC TRAY. Medical convenience kit.
Z-2240-2025
Recall number Z-2240-2025
Initiated June 11, 2025
Classification Class II
Status Ongoing
Quantity 40 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2240-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17523]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information Model No. BJAC006-27; UDI: 10809160394540; Kit Lot No. 1599252, 1609971, 1612404, 1640192.
Distribution pattern Domestic: CA, IL, MD, OH, PA, TX, WA.
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[2868]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 24
CARDIAC ROBOT PACK. Medical convenience kit.
Z-2241-2025
Recall number Z-2241-2025
Initiated June 11, 2025
Classification Class II
Status Ongoing
Quantity 20 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2241-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[35104]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information Model No. RYCB72-03; UDI: 10809160422830; Kit Lot No. 1608339.
Distribution pattern Domestic: CA, IL, MD, OH, PA, TX, WA.
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[2874]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 24
CT DAVINCI. Medical convenience kit.
Z-2242-2025
Recall number Z-2242-2025
Initiated June 11, 2025
Classification Class II
Status Ongoing
Quantity 12 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2242-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52653]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information Model No. WRNM089; UDI: 10809160432525; Kit Lot No. 1627141.
Distribution pattern Domestic: CA, IL, MD, OH, PA, TX, WA.
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[2880]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 24
DA VINCI PACK URO/PROSTATE. Medical convenience kit.
Z-2243-2025
Recall number Z-2243-2025
Initiated June 11, 2025
Classification Class II
Status Ongoing
Quantity 21 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2243-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17522]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information Model No. VAHT009-19; UDI: 10809160378748; Kit Lot No. 1579555.
Distribution pattern Domestic: CA, IL, MD, OH, PA, TX, WA.
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[2756]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 24
DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.
Z-2244-2025
Recall number Z-2244-2025
Initiated June 11, 2025
Classification Class II
Status Ongoing
Quantity 626 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2244-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58010]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information Model No. MAMC228-13, MAMC228-14, MAMC228-15; UDI: 10809160366943, 10809160366820, 10809160420980, 10809160421734, 10809160441046; Kit Lot No. 1576797, 1577255, 1586536, 1606044, 1607044, 1607825, 1615452, 1621487, 1621488, 1638247, 1639254, 1647833.
Distribution pattern Domestic: CA, IL, MD, OH, PA, TX, WA.
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[2468]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 24
DAVINCI UROLOGY. Medical convenience kit.
Z-2245-2025
Recall number Z-2245-2025
Initiated June 11, 2025
Classification Class II
Status Ongoing
Quantity 166 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2245-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17520]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information Model No. WRNM038-09, WRNM038-10, WRNM038-11; UDI: 10809160369302, 10809160418338, 10809160432259; Kit Lot No. 1589886, 1593087, 1606686, 1606688, 1615262, 1611133, 1627007.
Distribution pattern Domestic: CA, IL, MD, OH, PA, TX, WA.
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[2458]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 24
GEN LAPAROSCOPY PACK. Medical convenience kit.
Z-2246-2025
Recall number Z-2246-2025
Initiated June 11, 2025
Classification Class II
Status Ongoing
Quantity 321 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2246-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[29089]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information Model No. VMCC007-12; UDI: 10809160357200; Kit Lot No. 1592617, 1598707, 1608042, 1608043, 1621654.
Distribution pattern Domestic: CA, IL, MD, OH, PA, TX, WA.
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[38762]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 24
GENERAL LAPAROSCOPY TRAY. Medical convenience kit.
Z-2247-2025
Recall number Z-2247-2025
Initiated June 11, 2025
Classification Class II
Status Ongoing
Quantity 574 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2247-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17521]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information Model No. EURO010-08, USAR042-17, WILF006-29; UDI: 10809160414309, 10809160400586, 10809160429914, 10809160431108; Kit Lot No. 1616570, 1581675, 1594938, 1597550, 1600846, 1620149, 1620150, 1620151, 1622920.
Distribution pattern Domestic: CA, IL, MD, OH, PA, TX, WA.
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[2452]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 24
GENERAL ROBOTIC PACK. Medical convenience kit.
Z-2248-2025
Recall number Z-2248-2025
Initiated June 11, 2025
Classification Class II
Status Ongoing
Quantity 203 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2248-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[23218]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information Model No. NAFB082-04, NAMC473-01; UDI: 10809160395691, 10809160375037; Kit Lot No. 1568211, 1576237, 1599515, 1599516, 1605944, 1613558, 1616420, 1613626, 1625831, 1627259, 1628672, 1632042, 1635911.
Distribution pattern Domestic: CA, IL, MD, OH, PA, TX, WA.
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[2744]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2249-2025
Initiated June 11, 2025
Classification Class II
Status Ongoing
Quantity 816 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2249-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[35109]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information Model No. NAMC421-10, NAMC421-11, NAMC421-12; UDI: 10809160374597, 10809160417539, 10809160435779; Kit Lot No. 1584375, 1588403, 1605341, 1615427, 1615428, 1627706, 1628153, 1628008, 1628009, 1628647, 1632992.
Distribution pattern Domestic: CA, IL, MD, OH, PA, TX, WA.
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[2460]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2250-2025
Initiated June 11, 2025
Classification Class II
Status Ongoing
Quantity 346 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2250-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5467]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information Model No. NAFB055-08, NAMC436-11, VMCC030-06; UDI: 10809160405185, 10809160417621, 10809160415245, 10809160419021; Kit Lot No. 1595523, 1598524, 1598523, 1628236, 1634348, 1636865, 1645025, 1645227, 1608234, 1608349, 1608466, 1613607, 1613139, 1613608, 1616927, 1622475, 1628656, 1632993, 1596145, 1603597, 1608059, 1619856.
Distribution pattern Domestic: CA, IL, MD, OH, PA, TX, WA.
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[2765]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2251-2025
Initiated June 11, 2025
Classification Class II
Status Ongoing
Quantity 45 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2251-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[35107]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information Model No. NAMC474-01; UDI: 10809160375044; Kit Lot No. 1620573, 1620572, 1621883, 1621884, 1628673.
Distribution pattern Domestic: CA, IL, MD, OH, PA, TX, WA.
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[2610]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2252-2025
Initiated June 11, 2025
Classification Class II
Status Ongoing
Quantity 20 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2252-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52656]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information Model No. RYCB72-04; UDI: 10809160434666; Kit Lot No. 1625487.
Distribution pattern Domestic: CA, IL, MD, OH, PA, TX, WA.
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[2441]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2253-2025
Initiated June 11, 2025
Classification Class II
Status Ongoing
Quantity 85 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2253-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46701]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information Model No. VCIH007-06; UDI: 10809160379479, 10809160450758; Kit Lot No. 1569227, 1569228, 1569229, 1589126, 1608615, 1623944, 1643426.
Distribution pattern Domestic: CA, IL, MD, OH, PA, TX, WA.
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[2424]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2254-2025
Initiated June 11, 2025
Classification Class II
Status Ongoing
Quantity 18 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2254-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[40923]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information Model No. EURO011-08; UDI: 10809160414248; Kit Lot No. 1613056.
Distribution pattern Domestic: CA, IL, MD, OH, PA, TX, WA.
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[2740]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2255-2025
Initiated June 11, 2025
Classification Class II
Status Ongoing
Quantity 30 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2255-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46704]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
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Reason for recall CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information Model No. NIHB0036-07; UDI: 10809160403099; Kit Lot No. 1589877, 1612565.
Distribution pattern Domestic: CA, IL, MD, OH, PA, TX, WA.
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[2459]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2256-2025
Initiated June 11, 2025
Classification Class II
Status Ongoing
Quantity 452 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2256-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[29091]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
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Reason for recall CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information Model No. VAML025-05, WRNM007-15; UDI: 10809160387696, 10809160432235; Kit Lot No. 1580078, 1580079, 1580407, 1582536, 1585729, 1596605, 1598248, 1598249, 1607780, 1626103, 1629350, 1639643, 1627004.
Distribution pattern Domestic: CA, IL, MD, OH, PA, TX, WA.
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[2730]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2257-2025
Initiated June 11, 2025
Classification Class II
Status Ongoing
Quantity 292 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2257-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5465]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
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Reason for recall CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information Model No. USAR053-11; UDI: 10809160372357; Kit Lot No. 1578109, 1585712, 1597106, 1601742, 1601643, 1607925, 1612044, 1621429, 1637117.
Distribution pattern Domestic: CA, IL, MD, OH, PA, TX, WA.
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[2404]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2258-2025
Initiated June 11, 2025
Classification Class II
Status Ongoing
Quantity 128 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2258-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[23232]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information Model No. NIHB0022-09, NIHB0022-11, NIHB0022-12; UDI: 10809160381311, 10809160403730, 10809160440940; Kit Lot No. 1580032, 1590461, 1590463, 1604743, 1613180, 1613182, 1618989, 1641040.
Distribution pattern Domestic: CA, IL, MD, OH, PA, TX, WA.
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[2499]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2259-2025
Initiated June 11, 2025
Classification Class II
Status Ongoing
Quantity 656 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2259-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5466]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
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Reason for recall CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information Model No. RDLD047-10; UDI: 10809160358603; Kit Lot No. 1589630, 1590570, 1610157, 1617028, 1618142, 1621537, 1629589, 1635288, 1636852.
Distribution pattern Domestic: CA, IL, MD, OH, PA, TX, WA.
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[2451]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2260-2025
Initiated June 11, 2025
Classification Class II
Status Ongoing
Quantity 46 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2260-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11631]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information Model No. NIHB0035-07; UDI: 10809160404959; Kit Lot No. 1591938, 1622268, 1628944, 1632685.
Distribution pattern Domestic: CA, IL, MD, OH, PA, TX, WA.
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[2443]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2261-2025
Initiated June 11, 2025
Classification Class II
Status Ongoing
Quantity 52 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2261-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46697]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
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Reason for recall CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information Model No. NAMC077, NAMC077-02; UDI: 10809160318911, 10809160437971; Kit Lot No. 1591073, 1612261, 1616916, 1632036, 1632038, 1632359.
Distribution pattern Domestic: CA, IL, MD, OH, PA, TX, WA.
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[2422]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2262-2025
Initiated June 11, 2025
Classification Class II
Status Ongoing
Quantity 24 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2262-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46698]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information Model No. NAMC423-08; UDI: 10809160374627; Kit Lot No. 1624611, 1624612, 1628010.
Distribution pattern Domestic: CA, IL, MD, OH, PA, TX, WA.
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[2635]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2263-2025
Initiated June 11, 2025
Classification Class II
Status Ongoing
Quantity 372 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2263-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46700]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information Model No. RDLD050-09; UDI: 10809160413715; Kit Lot No. 1604510, 1604511, 1604512, 1606486, 1629590, 1633995, 1633997.
Distribution pattern Domestic: CA, IL, MD, OH, PA, TX, WA.
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[2752]
FDA event record
· Exact recall-number query on openFDA