Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical — Class II medical device recall Z-1411-2021
Ongoing recall by Covidien, reported 2021-04-21, distributed in AK, AL, AZ, CA, CO, CT, FL, GA…. Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II devi
| Recall number | Z-1411-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, Ponce, PR, United States |
| Recall initiated | 2021-03-05 |
| Classified | 2021-04-12 |
| Reported by FDA | 2021-04-21 |
| Distributed | AK, AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OR, PA, PR, SC, TX, UT, WA, WI, WV |
| Countries outside the US | AE, AT, AU, BE, BR, BS, CA, CH, CL, CY, DE, DK, EE, ES, FI, FR, GB, GR, GT, HU, ID, IE, IL, IT, JM, JP, KW, LB, MX, MY, NL, NO, NZ, PA, PE, PH, PL, PT, QA, RO, SA, SE, SG, SV, TH, TR, TT, TW, ZA |
| Quantity | 59,828 devices |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 10884523000887, 10884523000900, 10884523000917, 20884523000884, 20884523000907, 20884523000914 |
Product
Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094
Reason for recall
Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector component which connects the tubing to the device. This damage was determined to generate the particulate matter observed and is created during the assembly process for connecting the tubing component to the Y-Connector.
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-1411-2021. 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.