Two-stage and three-stage I — Class II medical device recall Z-0344-2016
Terminated recall by Stryker Medical Division of Stryker Corporation, reported 2015-12-09, distributed nationwide. It was identified by a customer complaint that some I.V. poles were retracting/lowering from an extended posit
| Recall number | Z-0344-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Medical Division of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2015-10-13 |
| Classified | 2015-11-30 |
| Reported by FDA | 2015-12-09 |
| Terminated | 2016-09-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BR, CA, CH, CL, CO, DE, ES, FR, GB, HK, IN, IT, JP, KR, MX, NL, NZ, PL, SG, ZA |
| Quantity | 19,876 |
| Model numbers | 1105, 1105E, 1105X, 1105XE, 1115, 1115E, 1115X, 1115XE, 1125E, 1125X, 1125XE, 2030, 3005 |
Product
Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or stretcher. The I.V. poles are stationary, height adjustable stands intended to hold infusion liquids, infusion accessories, and/or other medical devices. They may be used on the following parent devices: Model 2030 (EPIC II), model 3005 S3 beds and stretcher. models 1105, 1105E, 1105X, 1105XE, 1115, 1115E, 1115X, 1115XE, 1125E, 1125X and 1125XE.
Reason for recall
It was identified by a customer complaint that some I.V. poles were retracting/lowering from an extended position to the low height unexpectedly. An investigation was initiated which identified that the I.V. Latch Housing was nonconforming. potential hazards: " Suspended I.V. pole retracts unexpectedly " Suspended I.V. pole retracts unexpectedly with pump/bags attached
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-0344-2016. 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.