St — Class I medical device recall Z-0213-2018
Terminated recall by Sterilmed Inc, reported 2018-01-03, distributed nationwide. Inadequate seal due to lack of adhesive glue
| Recall number | Z-0213-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sterilmed Inc, Minneapolis, MN, United States |
| Recall initiated | 2017-06-02 |
| Classified | 2017-12-28 |
| Reported by FDA | 2018-01-03 |
| Terminated | 2019-07-29 |
| Distributed | Nationwide (US) |
| Quantity | 112 devices |
| Reason classes | packaging |
| Lot numbers | 7241712, 7251903, 7255673, 7259400, 7272027, 7273483, 7282741, 7290257, 7300290, 7308337, 7315539, 7316930, 7320863, 7322815, 7323722, 7324499, 7327999, 7330603, 7330645, 7330666, 7331054, 7342069, 7342081, 7342672, 7343120, 7343395, 7343501, 7343603, 7343643, 7343686, 7343766, 7343797, 7343838, 7344024, 7345129, 7345143, 7345592, 7346336, 7346820, 7348169 and 66 more |
| Model numbers | STJ408309, STJ408310, STJ408324 |
| Expiration dates | 2018-05-31 |
Product
St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Reason for recall
Inadequate seal due to lack of adhesive glue
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-0213-2018. 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.