Z-1184-2016Class II

Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher

Name: Z-1184-2016 Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher
Creator: Stryker Medical Division of Stryker Corporation
Published: 2016-02-05
License: https://open.fda.gov/license/

Stryker Medical / initiated 2016-02-05 / Terminated / root cause: manufacturing process

FDA source

Stryker Medical Division of Stryker Corporation began a recall of Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher on 2016-02-05. FDA classified it as Class II and gives the reason as "The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) were manufactured using the incorrect oil. The oil used does not contain the same wear resistance additives as the specified...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1184-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-05
Posted: 2016-03-17
Terminated: 2016-09-06
Recalling firm: Stryker Medical
Product: Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher
Product code: INK Stretcher, Wheeled, Powered
Reason for recall: The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) were manufactured using the incorrect oil. The oil used does not contain the same wear resistance additives as the specified oils and therefore its use increases the potential for wear which may cause a leak event or jack drift. Testing was done to evaluate the jacks with incorrect oil and leak events we
Root cause tag: manufacturing process
FDA root cause: Mixed-up of materials/components
Action: On 2/5/2016, URGENT MEDICAL DEVICE NOTIFICATION notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If you have any urgent questions or concerns, please, contact Stryker Customer Service at (1-800-327-0770). Our normal business hours are Monday-Friday 8 a.m.-5 p.m. (ET).
Quantity in commerce: 36
Distribution: Distributed in DC and the states of AL, CA, FL, MN, MT, NC, NE, NY, PA, RI, TN, TX, UT, and WV.
Product codes and lots: The hydraulic jack assemblies (Part numbers: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) used as service parts on Stretchers assembled from 8/28/15 - 8/29/15

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1184-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1184-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-17
Z-1185-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-17

Product code INK

K140095Class IIPrime Zoom StretcherStryker Corporation / cleared 2014-05-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)