Cadence Science Pressure Control Glass Syringe — Class II medical device recall Z-0365-2020
Terminated recall by Cadence Science, Inc., reported 2019-11-20, distributed nationwide. The glass syringe used with Pressure Control Syringes may potentially break during use.
| Recall number | Z-0365-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cadence Science, Inc., Cranston, RI, United States |
| Recall initiated | 2019-05-10 |
| Classified | 2019-11-13 |
| Reported by FDA | 2019-11-20 |
| Terminated | 2020-06-05 |
| Distributed | Nationwide (US) |
| Quantity | 237 |
| Reason classes | foreign material, device malfunction |
| UPC / GTIN / UDI-DI | 00816329023381, 00816329023398, 00816329023404, 00816329023411, 00816329023428, 00816329023435 |
| Model numbers | 5338, 5339, 5340, 5341, 5342, 5343, W020584/1, W026119/1, W029677/1, W030380/1, W033034/1, W034575/1, W037053/1, W037199/1, W037450/1, W037708/1, W039777/1, W040276/1, W040478/1, W040479/1, W040804/1, W042297/1, W043484/1, W044966/1, W045378/1 and 18 more |
Product
Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (GTIN #816329023404); 5341 (GTIN #816329023411); 5342 (GTIN #816329023428); 5343 (GTIN #816329023435) - Product Usage: General Hospital Use
Reason for recall
The glass syringe used with Pressure Control Syringes may potentially break during use.
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-0365-2020. 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.