EEA Autosuture Circular Stapler with DST Series Technology — Class II medical device recall Z-1322-2022
Ongoing recall by Covidien, LP, reported 2022-07-13, distributed nationwide. The affected staplers have the potential for the staple guide to not be securely attached to the instrument. T
| Recall number | Z-1322-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, LP, North Haven, CT, United States |
| Recall initiated | 2022-05-13 |
| Classified | 2022-07-01 |
| Reported by FDA | 2022-07-13 |
| Distributed | Nationwide (US) |
| Quantity | 433,560 |
| UPC / GTIN / UDI-DI | 10884523004731, 10884523004748, 10884523006056, 10884523006124 |
| Lot numbers | P0A1134KY, P0A1142KY, P0A1261KY, P0A1388KY, P0A1389KSY, P0A1497KY, P0A1498KSY, P0A1525KY, P0B0661KY, P0B0666KY, P0B0667KY, P0B1027KSY, P0B1081KY, P0B1082KY, P0B1083KSY, P0B1188KY, P0B1189KY, P0B1339KY, P0B1340KY, P0B1357KY, P0B1358KY, P0B1359KY, P0B1460KY, P0B1461KY, P0B1462KY, P0B1490KY, P0B1493KY, P0B1494KY, P0B1495KY, P0B1496KY, P0C0481KRY, P0C1177KSY, P0C1178KY, P0C1179KY, P0C1183KY, P0C1344KY, P0C1345KY, P0C1346KSY, P0C1349KY, P0C1350KY and 460 more |
| Model numbers | EEA25, EEA2535, EEAXL25, EEAXL2535 |
Product
EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.
Reason for recall
The affected staplers have the potential for the staple guide to not be securely attached to the instrument. The issue could cause the component to disengage and if disengaged, could allow the device to transect tissue without forming staples.
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-1322-2022. 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.