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ModerateClass IITerminated

FDA Devices recall · Reported December 9, 2015

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.

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 …

Recall #
Z-0344-2016
Affected scope
19,876
Initiated
October 13, 2015
Verify with FDA Devices →
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Stryker Medical Division of Stryker Corporation recalled Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or str… - a moderate-severity action.

Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or str… was recalled by Stryker Medical Division of Stryker Corporation in December 9, 2015. Reason: It was identified by a customer complaint that some I.V. poles were retracting/lowering from an extended pos…. Check the official notice for the remedy. Verify recall #Z-0344-2016 with the FDA Devices before acting.

The recall

Stryker Medical Division of Stryker Corporation issued this moderate-severity FDA Devices recall-It was identified by a customer complaint that some I.V. poles were retracting/lowering from an extended pos….

Moderate
severity level
20K units
affected scope
Class II
classification
December 9, 2015
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0344-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-0344-2016
Date reported December 9, 2015
Date initiated October 13, 2015
Recalling firm Stryker Medical Division of Stryker Corporation
Firm location Portage, MI
Affected scope 19,876
Distribution Worldwide Distribution-US (nationwide) including DC and Guam, and the countries of New Zealand Canada Chile Hong Kong Colombia Argentina Brazil France Germany Italy Netherlands Spain Switzerland United Kingdom India Japan South Korea Mexi…

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

19,876 units affected - limited or regional distribution scale.

Regional (<10K units) -
Multi-state (10K – 100K units) ✓ This recall
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-0344-2016) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
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.. Recalled by Stryker Medical Division of Stryker Corporation. Units affected: 19,876.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on December 9, 2015. Severity: Moderate. Recall number: Z-0344-2016.
Where was the recalled product distributed?
Distribution: Worldwide Distribution-US (nationwide) including DC and Guam, and the countries of New Zealand Canada Chile Hong Kong Colombia Argentina Brazil France Germany Italy Netherlands Spain Switzerland United Kingdom India Japan South Korea Mexico South Africa Poland Singapore..
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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This recall: FDA Devices, reported December 9, 2015. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026