FDA Medical Device Recalls (openFDA)
Karl Storz Endoscopy America Inc: Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
- Recall number
- Z-1308-2013
- Recalling firm
- Karl Storz Endoscopy America Inc
- Product
- Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
- Status
- Terminated
- Initiated
- 2009-06-01
- Posted
- 2013-05-11
- Terminated
- 2013-05-13
- Reason
- Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
- Root cause
- Packaging
- Action
- A Safety Alert dated May 29, 2009 was sent to affected customers. The letter informed them of possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products which may result in airborne contamination. Karl Storz requested consignees to inspect their inventory of the subject products thoroughly and look for small holes in the blister trays. Any identified units should be returned to Karl Storz, and a replacement package (6 units per package) will be provided to at no charge. The Karl Storz Customer Support number 1-800-421-0837 ext. 7577 was provided to obtain a Return Authorization Number (RMA) and arrange replacement. Questions and comments were forwarded to Technical Support at 1-800-421-0837 ext. 5350.
- Quantity
- 9432 units
- Distribution
- Distributed Nationwide and in Canada.
- Lot, serial or model codes
- Lot 36832
- 510(k) numbers
- ["K934647","K983569"]
- PMA numbers
- not on file
- Product code
- FJL
- Firm FEI
- 2020550
- Firm city
- El Segundo
- 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
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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