FDA Medical Device Recalls (openFDA)
Stryker Endoscopy: 24mm Rotating C-Mount Coupler, Model Number 1088-020-121S2. The device in indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope, endoscope or arthroscope is indicated for use.
- Recall number
- Z-1558-2008
- Recalling firm
- Stryker Endoscopy
- Product
- 24mm Rotating C-Mount Coupler, Model Number 1088-020-121S2. The device in indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope, endoscope or arthroscope is indicated for use.
- Status
- Terminated
- Initiated
- 2008-03-31
- Posted
- 2008-08-24
- Terminated
- 2008-09-17
- Reason
- The coupler on this device was manufactured without set-screws that are used to hold and center the rear assembly and the endobody. The coupler is part of the camera system and affects the ability to focus.
- Root cause
- Nonconforming Material/Component
- Action
- Only one customer had all of the defective couplers. The firm called this customer on March 27, 2008, and asked that the 28 couplers remaining in their possession be returned.
- Quantity
- 28 units
- Distribution
- Product was delivered to one consignee in Iowa.
- Lot, serial or model codes
- Model Number: 1088-020-121S2 Lot Numbers: Shipped: 07L046134, 07L046144, 07L046154, 07L046164, 07L046184, 07L046194, 07L046214, 07L046224, 07L046234, 07L046244, 07L046254, 07L046274, 07L046284, 07L046294, 07L046304, 07L046324, 07L046334, 07L046344, 07L046364, 07L046374, 07L046384, 07L046394, 07L046404, 07L046414, 07L046424, 07L046454, 07L046464, and 07L046474.
- 510(k) numbers
- ["K983566"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 2936485
- Firm city
- San Jose
- Firm state
- CA
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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