Custom procedure trays containing medical components needed to… — Class II medical device recall Z-1520-2020
Terminated recall by Avid Medical, Inc., reported 2020-03-25, distributed in AZ, CA, IL, IN, MD, MS, NJ, NV…. The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locati
| Recall number | Z-1520-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Avid Medical, Inc., Toano, VA, United States |
| Recall initiated | 2020-02-18 |
| Classified | 2020-03-19 |
| Reported by FDA | 2020-03-25 |
| Terminated | 2020-11-23 |
| Distributed | AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX, VA, WI |
| Quantity | 1,001 units |
| Reason classes | sterility |
| Lot numbers | 1320621, 1329060, 1337288, 1337499, 1340260, 1342539, 1343857, 1344733, 1356016, 1356568, 1357442, 1357815, 1359042, 1362293, 1362314, 1363219, 1363243, 1363557, 1363636, 1363778, 1365656, 1368746, 1370233, 1370391, 1371692, 1372029, 1373730, 1375786, 1376609, 1377795, 1378737, 1379931, 1380256, 1381718, 1381720, 1381721, 1384785 |
| Model numbers | 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 |
| Expiration dates | 2020-06-30, 2020-12-15 |
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.
Reason for recall
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 a risk of cross contamination.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1520-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.