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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97149

24 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

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
Recalling firm
AVID Medical, Inc.
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.

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.

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
Recalling firm
AVID Medical, Inc.
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.

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.

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
Recalling firm
AVID Medical, Inc.
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.

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.

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
Recalling firm
AVID Medical, Inc.
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.

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.

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
Recalling firm
AVID Medical, Inc.
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.

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.

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
Recalling firm
AVID Medical, Inc.
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.

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.

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
Recalling firm
AVID Medical, Inc.
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.

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.

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
Recalling firm
AVID Medical, Inc.
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.

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.

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
Recalling firm
AVID Medical, Inc.
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.

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.

device · product 10 of 24

GS ENDOSCOPY PACK. Medical convenience kit.

Z-2249-2025
Recall number
Z-2249-2025
Initiated
June 11, 2025
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
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.

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.

device · product 11 of 24

GYN LAPAROSCOPY PACK. Medical convenience kit.

Z-2250-2025
Recall number
Z-2250-2025
Initiated
June 11, 2025
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
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.

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.

device · product 12 of 24

GYN ROBOTIC PACK. Medical convenience kit.

Z-2251-2025
Recall number
Z-2251-2025
Initiated
June 11, 2025
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
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.

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.

device · product 13 of 24

HVI CARDIAC ROBOT PACK. Medical convenience kit.

Z-2252-2025
Recall number
Z-2252-2025
Initiated
June 11, 2025
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
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.

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.

device · product 14 of 24

LAP CHOLE PACK. Medical convenience kit.

Z-2253-2025
Recall number
Z-2253-2025
Initiated
June 11, 2025
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
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.

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.

device · product 15 of 24

LAPAROSCOPIC GYN. Medical convenience kit.

Z-2254-2025
Recall number
Z-2254-2025
Initiated
June 11, 2025
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
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.

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.

device · product 16 of 24

LAPAROSCOPIC PROSTATECTOMY. Medical convenience kit.

Z-2255-2025
Recall number
Z-2255-2025
Initiated
June 11, 2025
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
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.

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. NIHB0036-07; UDI: 10809160403099; Kit Lot No. 1589877, 1612565.

Distribution pattern

Domestic: CA, IL, MD, OH, PA, TX, WA.

device · product 17 of 24

LAPAROSCOPY PACK. Medical convenience kit.

Z-2256-2025
Recall number
Z-2256-2025
Initiated
June 11, 2025
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
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.

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. 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.

device · product 18 of 24

LAVH PACK. Medical convenience kit.

Z-2257-2025
Recall number
Z-2257-2025
Initiated
June 11, 2025
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
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.

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. 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.

device · product 19 of 24

MAJOR THORACOSCOPY BASIN. Medical convenience kit.

Z-2258-2025
Recall number
Z-2258-2025
Initiated
June 11, 2025
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
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.

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.

device · product 20 of 24

PACK GENERAL ROBOTIC. Medical convenience kit.

Z-2259-2025
Recall number
Z-2259-2025
Initiated
June 11, 2025
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
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.

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. 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.

device · product 21 of 24

PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit.

Z-2260-2025
Recall number
Z-2260-2025
Initiated
June 11, 2025
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
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.

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.

device · product 22 of 24

PARTIAL NEPHRECTOMY PACK. Medical convenience kit.

Z-2261-2025
Recall number
Z-2261-2025
Initiated
June 11, 2025
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
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.

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. 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.

device · product 23 of 24

ROBOTIC PROSTATECTOMY PACK. Medical convenience kit.

Z-2262-2025
Recall number
Z-2262-2025
Initiated
June 11, 2025
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
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.

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.

device · product 24 of 24

ROBOTIC URO/GYN PACK. Medical convenience kit.

Z-2263-2025
Recall number
Z-2263-2025
Initiated
June 11, 2025
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
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.

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.

Field note

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