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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

Avid Medical, Inc.: The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing

Agency Publication Date: March 19, 2020
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Affected Products

Product: Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

Item Codes:ADVC033-16, ADVG034-15, ADVU018-24, JNTH001-04, JNTH001-05, JNTH002-05, SHER019-07, YAVA100-05. Lot Numbers: 1344066, 1344358, 1353858, 1353860, 1354012, 1359439, 1361116, 1361767, 1363232, 1365746, 1379393. Expiration dates: 2/28/21 thru 7/30/2022.

Lot Numbers:
Numbers
Product: Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

Item Codes: ADBR003-14, ADBR008-19, ADBR010-10, ADBR012-13, ADBR014-14, ADBR015-15, ADBR020-05, ADBR021-23, ADBR022-25, ADBR032-06, ADCO004-21, ADCO021-15, ADCO027-13, ADCO028-17, ADCO033-06, ADCO038-05, ADEU001-05, ADVC006-21, ADVC008-27, ADVC009-27, ADVC011-24, ADVC017-29, ADVC018-27, ADVC025-16, ADVC034-23, ADVC043-17, ADVC058-14, ADVC059-19, ADVC085-08, ADVC086-08, ADVC089-08, ADVC092-07, ADVC200-06, ADVC204-06, ADVC208-07, ADVD001-20, ADVD002-17, ADVD015-06, ADVD018-08, ADVG003-34, ADVG004-26, ADVG005-29, ADVG014-21, ADVG019-25, ADVG019-25, ADVG021-29, ADVG030-22, ADVG041-21, ADVG049-10, ADVH007-31, ADVH008-32, ADVH009-38, ADVH096-02, ADVM001-22, ADVM009-15, ADVM011-19, ADVM012-15, ADVM017-21, ADVM020-16, ADVM021-21, ADVM022-18, ADVM024-19, ADVM033-13, ADVM036-08, ADVM038-08, ADVM039-06, ADVM039-07, ADVR003-23, ADVR012-20, ADVR036-06, ADVT020-13, ADVT024-12, ADVT026-13, ADVT028-13, ADVT035-11, ADVU019-16, ADVU025-15, ADVU026-16, ADVU027-20, ADVU028-14, ADVU037-13, ADVU040-06, ADVU042-07, CHWE008, CHWE011, CMRL001-02, CNSC013-06, EDHN004-04, MADN030-06, MADN032-06, MADN033-07, MDVC001, NWHR006-01, NWHR006-02, NWHR007, NWHR013-01, NWHR016-01, NWHR018-01, NWHR020-01, PCHM005-08, RMRI010-20, RVRH009-01, SHER009-13, SHER013-10, SHER021-06, SHER023-08, SHER026-06, SINA130-01, SINA201-01, SINA204-01, SINA205-01, SINA206-01, SINA207-01, SINA210-01, SINA225, SINA226, SINA226-01, SINA230, SINA232, VANA017-01, YAVA105-04, YAVA106-03, YAVA108-04, YAVA112-04, YAVA116-04, YAVA121-06, YAVA121-07, YAVA123-07. Lot Numbers: 1322955, 1331381, 1331528, 1334505, 1334575, 1336084, 1336360, 1336778, 1336906, 1338531, 1338698, 1338855, 1338880, 1338925, 1339216, 1339567, 1340277, 1340685, 1340692, 1340698, 1341118, 1341392, 1341413, 1341835, 1342023, 1342031, 1342537, 1342538, 1342707, 1342844, 1342973, 1343173, 1343221, 1343850, 1344150, 1344402, 1344805, 1344967, 1345175, 1345302, 1345319, 1345538, 1345798, 1346559, 1346562, 1347895, 1348045, 1348111, 1348213, 1348215, 1348338, 1348392, 1348413, 1348753, 1348976, 1349028, 1349390, 1349727, 1349728, 1349947, 1350158, 1350293, 1350294, 1350295, 1350299, 1350547, 1351204, 1351577, 1352730, 1353391, 1353395, 1353396, 1353406, 1353987, 1357567, 1357572, 1357941, 1358280, 1358550, 1358762, 1358884, 1359049, 1359245, 1359246, 1359295, 1359298, 1359985, 1360227, 1360228, 1360327, 1360332, 1360333, 1360362, 1360689, 1360701, 1360795, 1360993, 1361000, 1361102, 1361103, 1361145, 1361159, 1361207, 1361378, 1361444, 1361567, 1361910, 1362076, 1362166, 1362315, 1362388, 1362389, 1362402, 1362558, 1362725, 1362851, 1362872, 1362873, 1362916, 1363040, 1363105, 1363218, 1363227, 1363238, 1363241, 1363253, 1363254, 1363561, 1363635, 1363637, 1363766, 1363932, 1364250, 1364304, 1364311, 1364312, 1364325, 1364326, 1364327, 1364464, 1364697, 1364948, 1365295, 1365501, 1365502, 1365661, 1365662, 1365664, 1365740, 1365742, 1365967, 1365968, 1365975, 1365976, 1366362, 1366363, 1366423, 1366425, 1366495, 1366665, 1366763, 1366769, 1366777, 1366915, 1367017, 1367021, 1367109, 1367212, 1367231, 1367336, 1367408, 1367413, 1367780, 1367781, 1367895, 1367988, 1367991, 1367998, 1368000, 1368407, 1368408, 1368409, 1368589, 1368713, 1368729, 1368733, 1368734, 1368735, 1368757, 1368941, 1368944, 1369037, 1369133, 1369141, 1369377, 1369379, 1369389, 1369401, 1369402, 1369403, 1369404, 1369417, 1369621, 1369716, 1369721, 1369789, 1369791, 1369932, 1370081, 1370082, 1370083, 1370085, 1370232, 1370238, 1370371, 1370376, 1370379, 1370380, 1370385, 1370386, 1370392, 1370513, 1370515, 1370516, 1370892, 1370893, 1370901, 1371096, 1371099, 1371105, 1371177, 1371220, 1371221, 1371237, 1371321, 1371491, 1371589, 1371644, 1371787, 1371870, 1371877, 1372019, 1372020, 1372021, 1372141,1372147, 1372212, 1372293, 1372299, 1372307, 1372401, 1372404, 1372467, 1372468, 1372471, 1372472, 1372473, 1372474, 1372476, 1372480, 1372495, 1372499, 1372983, 1372984, 1373146, 1373153, 1373228, 1373232, 1373340, 1373343, 1373346, 1373521, 1373721, 1373722, 1373905, 1373966, 1373971, 1374233, 1374252, 1374309, 1374571, 1374575, 1374893, 1374904, 1374989, 1374990, 1375095, 1375310, 1375315, 1375644, 1375650, 1375651, 1375655, 1375785, 1375857, 1375858, 1375872, 1376194, 1376229, 1376630, 1376672, 1376914, 1376915, 1376918, 1376989, 1377097, 1377101, 1377160, 1377278, 1377371, 1377372, 1377467, 1377523, 1377528, 1377532, 1377536, 1377630, 1377644, 1377800, 1377852, 1378410, 1378506, 1378656, 1379204, 1379543, 1379569, 1379571, 1379676, 1379685, 1379688, 1379932, 1379933, 1379939, 1380731, 1380737, 1380743, 1380751, 1380775, 1380776, 1380785, 1380786, 1380812, 1380823, 1380886, 1380892, 1380894, 1380916, 1380923, 1380927, 1380932, 1380939, 1381099, 1381453, 1381724, 1381755, 1381926, 1382029, 1382224, 1382225, 1382226, 1382228, 1382348, 1382490, 1382530, 1382572, 1382759, 1382760, 1382761, 1383413, 1383497, 1383534, 1383539, 1383544, 1383794, 1383795, 1383934, 1383935, 1383936, 1383939, 1383940, 1383947, 1384279, 1384527, 1384728, 1384786, 1384855, 1385587, 1388152. Expiration dates: 02/01/2020 thru 02/06/2023.

Lot Numbers:
Numbers
Product: Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

Item Codes: ADBR043-08, ADCO001-20, ADCO001-20, ADCO002-15, ADCO005-29, ADCO007-21, ADVC015-23, ADVC032-21, ADVC046-12, ADVH073-13, ADVM040-07, ADVM050-02, SHER020-10, SINA223, VAHT026-07, YAVA115-04, YAVA130, YAVA131-03. Lot numbers: 1333107, 1333471, 1336767, 1337370, 1339098, 1339331, 1342016, 1347760, 1347896, 1348407, 1353068, 1353419, 1354811, 1357043, 1359839, 1360420, 1361445, 1363245, 1365971, 1367018, 1367137, 1367218, 1367987, 1368726, 1369130, 1370525, 1370700, 1370929, 1371222, 1372022, 1372310, 1372407, 1373347, 1374864, 1375307, 1375787, 1376196, 1376397, 1378227, 1380392, 1380874, 1381757, 1382980, 1383533, 1384526, 1385192. Expiration Dates: 9/30/2020-10/17/2022

Lot Numbers:
numbers
Product: Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

Item Codes: ADVC065-18, ADVC068-21, ADVH078-17, ADVM042-07. Lot Numbers: 1324410, 1344158, 1356561, 1366768, 1372012, 1373518, 1375096, 1377349, 1378072, 1378073, 1379861, 1381271, 1381272. Expiration dates: 05/01/2020-09/30/2021.

Lot Numbers:
Numbers
Product: Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

Item Codes: SHER010-12. Lot Numbers: 1339900, 1352089, 1361835, 1370391, 1372029. Expiration dates: 12/15/2020-09/05/2021. ,

Lot Numbers:
Numbers
Product: Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

Item Codes: ADBR013-17, ADCO013-17, ADCO015-17, ADCO016-17, ADVG010-24, ADVH032-25, ADVH049-17, ADVM015-26, ADVM018-25, ADVR034-09, ADVU020-17, NWHR010-01, SINA212. Lot Codes: 1320621, 1329060, 1337288, 1337499, 1340260, 1342539, 1343857, 1344733, 1356016, 1356568, 1357442, 1357815, 1359042, 1362293, 1362314, 1363219, 1363243, 1363557, 1363636, 1363778, 1365656, 1368746, 1370233, 1371692, 1373730, 1375786, 1376609, 1377795, 1378737, 1379931, 1380256, 1381718, 1381720, 1381721, 1384785. Expiration Dates: 06/30/2020-06/25/2021.1370391, 1372029. Expiration dates: 12/15/2020-09/05/2021. ,

Lot Numbers:
Codes
Product: Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

Item Codes: ADCO026-17, SINA217. Lot Numbers: 1336261, 1361099, 1363225, 1367696, 1371095, 1374420, 1376394, 1383159. Expiration dates: 02/10/2020-11/18/2022.

Lot Numbers:
Numbers
Product: Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

Item Codes: ADBR023-09, ADVC026-20, ADVC026-20, ADVC028-19, ADVG020-28, ADVG040-16, ADVG042-11, ADVH017-26, ADVH019-22, ADVM010-14, ADVT021-12, ADVU008-17, ADVU036-10, ADVU041-07, NWHR011-01, SHER007-10, SHER017-09, SINA215, SINA229, SINA246-01, YAVA102-04, YAVA114-07, YAVA118-02. Lot Numbers: 1334810, 1335648, 1336974, 1341358, 1341365, 1341404, 1342580, 1345312, 1345675, 1345677, 1350309, 1350975, 1353716, 1358493, 1359443, 1360017, 1362230, 1362875, 1362996, 1363269, 1365415, 1365448, 1365737, 1366054, 1368755, 1369662, 1369785, 1370089, 1370226, 1370706, 1370902, 1371225, 1371226, 1371322, 1372024, 1372478, 1373852, 1374118, 1375649, 1375790, 1377540, 1377798, 1378061, 1378483, 1379389, 1380106, 1380920, 1381113, 1382221, 1382231, 1383929, 1383931, 1384518. Expiration dates: 01/31/2020-11/08/2022.

Lot Numbers:
Numbers
Product: Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

Item Codes: ADBR019-16, ADBR019-17, ADBR025-09, ADBR048-01, ADCO014-17, ADVC001-23, ADVC001-25, ADVC004-24, ADVC007-30, ADVC201-05, ADVC202-07, ADVC205-06, ADVD004-16, ADVD017-06, ADVG011-23, ADVG012-21, ADVG013-19, ADVG015-22, ADVG016-32, ADVM019-17, ADVM034-11, ADVM041-08, ADVT030-21, ADVU012-17, ADVU013-16, ADVU014-23, ADVU015-18, NWHR001, SHER002-12, SHER004-12, SHER008-12, SHER011-11, SHER025-07, SINA207, VMCI005, YAVA125-08, YAVA127-05. Lot Numbers: 1320840, 1331256, 1331443, 1331444, 1331467, 1331929, 1335097, 1336484, 1337355, 1337359, 1338609, 1339352, 1341351, 1342664, 1342763, 1343707, 1343830, 1344151, 1345679, 1345802, 1349993, 1350160, 1350726, 1352818, 1353070, 1355493, 1356573, 1357429, 1358558, 1359285, 1361447, 1361826, 1362710, 1362918, 1363271, 1363423, 1363772, 1364857, 1365071, 1365738, 1366778, 1367348, 1367349, 1367351, 1367352, 1367582, 1367779, 1367999, 1368736, 1368738, 1369131, 1369132, 1369135, 1369139, 1369392, 1369413, 1370223, 1370236, 1370528, 1370649, 1371098, 1371223, 1371323, 1371328, 1371329, 1372015, 1372023, 1372295, 1372398, 1372498, 1373723, 1374239, 1375312, 1375313, 1375789, 1375871, 1376097, 1376457, 1376608, 1377366, 1377368, 1377526, 1377539, 1377708, 1378500, 1380560, 1380561, 1380562, 1380745, 1380760, 1380828, 1381741, 1382210, 1383542, 1383796, 1383932, 1383933, 1383941, 1384529, 1385588, 1386135. Expiration Dates: 03/31/2020-12/11/2022.

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85049
Status: Resolved
Manufacturer: Avid Medical, Inc.
Manufactured In: United States
Units Affected: 9 products (21,326 each; 1,906 each; 1,644 each; 400 each; 230 each; 1,001 each; 628; 2,632 each; 5,004 each)

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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 · 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.