1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube… — Class II medical device recall Z-0695-2018
Terminated recall by DePuy Mitek, Inc., a Johnson & Johnson Co., reported 2018-03-07, distributed nationwide. Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
| Recall number | Z-0695-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Mitek, Inc., a Johnson & Johnson Co., Raynham, MA, United States |
| Recall initiated | 2017-08-31 |
| Classified | 2018-02-23 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2019-04-09 |
| Distributed | Nationwide (US) |
| Quantity | 15,678 |
| Reason classes | packaging |
| Lot numbers | 1067, 138, 1741, 194, 2576, 2608, 2645, 633 |
Product
1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures.
Reason for recall
Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
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-0695-2018. 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.