FDA Medical Device Recalls (openFDA)
Stryker Medical Division of Stryker Corporation: Eye Surgery Stryker Medical Stretchers Model 1089 Intended to transport patients in a horizontal position.
- Recall number
- Z-2864-2011
- Recalling firm
- Stryker Medical Division of Stryker Corporation
- Product
- Eye Surgery Stryker Medical Stretchers Model 1089 Intended to transport patients in a horizontal position.
- Status
- Terminated
- Initiated
- 2011-07-19
- Posted
- 2011-07-22
- Terminated
- 2013-08-29
- Reason
- The firm has determined that the brake rod assemblies of various stretchers that were built with a 5th wheel were manufactured with roll pins that did not meet the materials specifications. Some roll pins may have fractured during the assembly process and could fall out of the brake rod assemblies, rendering the brake or steer systems inoperable from certain pedals or causing a reduction in overa
- Root cause
- Nonconforming Material/Component
- Action
- Stryker Medical sent an "Urgent Medical Device Correction" dated July 19 ,2011 to all affected customers. The letter included; the name and model numbers of the stretchers, the reason for the correction and dates of manufacture. It contained the instructions to check the braking system and if found to be inoperable, to remove it from service, and if operable to check prior to each use. Also, information regarding contacting the recipients of any loaned or sold stretchers to relay the information in the letter and Medwatch reporting information. A self addressed postcard to confirm receipt of the letter was also included. For additional information call (269) 389-6604.
- Quantity
- 5
- Distribution
- Worldwide Distribution: Nationwide (USA) including the states of NY, MI, LA and CA ,and the countries of Canada, China, Spain, Japan, Korea, United Kingdom, South Africa.
- Lot, serial or model codes
- Model: 1089 Lots: 1102034587, 1102034588, 1102034589, 1102034590, and 1102034591.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FPO
- Firm FEI
- 1831750
- Firm city
- Portage
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28