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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

CLEARIFY Visualization System Recalled for Discoloration from Resterilization

Agency Publication Date: August 4, 2025
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Summary

AVID Medical, Inc. is recalling 5,365 units of the CLEARIFY Visualization System, which were distributed inside various surgical convenience kits and trays. These medical kits were inadvertently resterilized during production, causing the visualization systems to become discolored. The recall involves multiple types of surgical bundles, including those for Da Vinci robotic systems, urology, and laparoscopic procedures, sold at medical facilities and surgical centers.

Risk

Although no injuries have been reported, the inadvertent resterilization may have compromised the product's appearance or functional integrity. Using a discolored or potentially degraded device during surgery could interfere with visualization or lead to unexpected procedural complications.

What You Should Do

  1. The recalled products include multiple surgical convenience kits containing the CLEARIFY Visualization System, such as Laparoscopic Trays, Da Vinci Urology packs, and General Robotic bundles.
  2. Identify affected products by checking the model number, Unique Device Identifier (UDI), and kit lot number printed on the external packaging label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled products. Contact AVID Medical, Inc. or your distributor immediately to arrange for the return, replacement, or correction of any remaining inventory.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: LAPAROSCOPIC TRAY Medical convenience kit
Model / REF:
BJAC006-27
Lot Numbers:
1599252
1609971
1612404
1640192
UDI:
10809160394540

Recall #: Z-2240-2025; Quantity: 40 units

Product: CARDIAC ROBOT PACK Medical convenience kit
Model / REF:
RYCB72-03
Lot Numbers:
1608339
UDI:
10809160422830

Recall #: Z-2241-2025; Quantity: 20 units

Product: CT DAVINCI Medical convenience kit
Model / REF:
WRNM089
Lot Numbers:
1627141
UDI:
10809160432525

Recall #: Z-2242-2025; Quantity: 12 units

Product: DA VINCI PACK URO/PROSTATE Medical convenience kit
Model / REF:
VAHT009-19
Lot Numbers:
1579555
UDI:
10809160378748

Recall #: Z-2243-2025; Quantity: 21 units

Product: DAVINCI TRUCUSTOM BUNDLE Medical convenience kit
Model / REF:
MAMC228-13
MAMC228-14
MAMC228-15
Lot Numbers:
1576797
1577255
1586536
1606044
1607044
1607825
1615452
1621487
1621488
1638247
1639254
1647833
UDI:
10809160366943
10809160366820
10809160420980
10809160421734
10809160441046

Recall #: Z-2244-2025; Quantity: 626 units

Product: DAVINCI UROLOGY Medical convenience kit
Model / REF:
WRNM038-09
WRNM038-10
WRNM038-11
Lot Numbers:
1589886
1593087
1606686
1606688
1615262
1611133
1627007
UDI:
10809160369302
10809160418338
10809160432259

Recall #: Z-2245-2025; Quantity: 166 units

Product: GEN LAPAROSCOPY PACK Medical convenience kit
Model / REF:
VMCC007-12
Lot Numbers:
1592617
1598707
1608042
1608043
1621654
UDI:
10809160357200

Recall #: Z-2246-2025; Quantity: 321 units

Product: GENERAL LAPAROSCOPY TRAY Medical convenience kit
Model / REF:
EURO010-08
USAR042-17
WILF006-29
Lot Numbers:
1616570
1581675
1594938
1597550
1600846
1620149
1620150
1620151
1622920
UDI:
10809160414309
10809160400586
10809160429914
10809160431108

Recall #: Z-2247-2025; Quantity: 574 units

Product: GENERAL ROBOTIC PACK Medical convenience kit
Model / REF:
NAFB082-04
NAMC473-01
Lot Numbers:
1568211
1576237
1599515
1599516
1605944
1613558
1616420
1613626
1625831
1627259
1628672
1632042
1635911
UDI:
10809160395691
10809160375037

Recall #: Z-2248-2025; Quantity: 203 units

Product: GS ENDOSCOPY PACK Medical convenience kit
Model / REF:
NAMC421-10
NAMC421-11
NAMC421-12
Lot Numbers:
1584375
1588403
1605341
1615427
1615428
1627706
1628153
1628008
1628009
1628647
1632992
UDI:
10809160374597
10809160417539
10809160435779

Recall #: Z-2249-2025; Quantity: 816 units

Product: GYN LAPAROSCOPY PACK Medical convenience kit
Model / REF:
NAFB055-08
NAMC436-11
VMCC030-06
Lot Numbers:
1595523
1598524
1598523
1628236
1634348
1636865
1645025
1645227
1608234
1608349
1608466
1613607
1613139
1613608
1616927
1622475
1628656
1632993
1596145
1603597
1608059
1619856
UDI:
10809160405185
10809160417621
10809160415245
10809160419021

Recall #: Z-2250-2025; Quantity: 346 units

Product: GYN ROBOTIC PACK Medical convenience kit
Model / REF:
NAMC474-01
Lot Numbers:
1620573
1620572
1621883
1621884
1628673
UDI:
10809160375044

Recall #: Z-2251-2025; Quantity: 45 units

Product: HVI CARDIAC ROBOT PACK Medical convenience kit
Model / REF:
RYCB72-04
Lot Numbers:
1625487
UDI:
10809160434666

Recall #: Z-2252-2025; Quantity: 20 units

Product: LAP CHOLE PACK Medical convenience kit
Model / REF:
VCIH007-06
Lot Numbers:
1569227
1569228
1569229
1589126
1608615
1623944
1643426
UDI:
10809160379479
10809160450758

Recall #: Z-2253-2025; Quantity: 85 units

Product: LAPAROSCOPIC GYN Medical convenience kit
Model / REF:
EURO011-08
Lot Numbers:
1613056
UDI:
10809160414248

Recall #: Z-2254-2025; Quantity: 18 units

Product: LAPAROSCOPIC PROSTATECTOMY Medical convenience kit
Model / REF:
NIHB0036-07
Lot Numbers:
1589877
1612565
UDI:
10809160403099

Recall #: Z-2255-2025; Quantity: 30 units

Product: LAPAROSCOPY PACK Medical convenience kit
Model / REF:
VAML025-05
WRNM007-15
Lot Numbers:
1580078
1580079
1580407
1582536
1585729
1596605
1598248
1598249
1607780
1626103
1629350
1639643
1627004
UDI:
10809160387696
10809160432235

Recall #: Z-2256-2025; Quantity: 452 units

Product: LAVH PACK Medical convenience kit
Model / REF:
USAR053-11
Lot Numbers:
1578109
1585712
1597106
1601742
1601643
1607925
1612044
1621429
1637117
UDI:
10809160372357

Recall #: Z-2257-2025; Quantity: 292 units

Product: MAJOR THORACOSCOPY BASIN Medical convenience kit
Model / REF:
NIHB0022-09
NIHB0022-11
NIHB0022-12
Lot Numbers:
1580032
1590461
1590463
1604743
1613180
1613182
1618989
1641040
UDI:
10809160381311
10809160403730
10809160440940

Recall #: Z-2258-2025; Quantity: 128 units

Product: PACK GENERAL ROBOTIC Medical convenience kit
Model / REF:
RDLD047-10
Lot Numbers:
1589630
1590570
1610157
1617028
1618142
1621537
1629589
1635288
1636852
UDI:
10809160358603

Recall #: Z-2259-2025; Quantity: 656 units

Product: PARTIAL NEPHRECTOMY - ROBOTIC Medical convenience kit
Model / REF:
NIHB0035-07
Lot Numbers:
1591938
1622268
1628944
1632685
UDI:
10809160404959

Recall #: Z-2260-2025; Quantity: 46 units

Product: PARTIAL NEPHRECTOMY PACK Medical convenience kit
Model / REF:
NAMC077
NAMC077-02
Lot Numbers:
1591073
1612261
1616916
1632036
1632038
1632359
UDI:
10809160318911
10809160437971

Recall #: Z-2261-2025; Quantity: 52 units

Product: ROBOTIC PROSTATECTOMY PACK Medical convenience kit
Model / REF:
NAMC423-08
Lot Numbers:
1624611
1624612
1628010
UDI:
10809160374627

Recall #: Z-2262-2025; Quantity: 24 units

Product: ROBOTIC URO/GYN PACK Medical convenience kit
Model / REF:
RDLD050-09
Lot Numbers:
1604510
1604511
1604512
1606486
1629590
1633995
1633997
UDI:
10809160413715

Recall #: Z-2263-2025; Quantity: 372 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97149
Status: Active
Manufacturer: AVID Medical, Inc.
Sold By: Medical facilities; Specialized surgical centers
Manufactured In: United States
Units Affected: 24 products (40 units; 20 units; 12 units; 21 units; 626 units; 166 units; 321 units; 574 units; 203 units; 816 units; 346 units; 45 units; 20 units; 85 units; 18 units; 30 units; 452 units; 292 units; 128 units; 656 units; 46 units; 52 units; 24 units; 372 units)
Distributed To: California, Illinois, Maryland, Ohio, Pennsylvania, Texas, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.