FDA Medical Device Recalls (openFDA)
Keeler Instruments Inc: Keeler All Pupil II Indirect Ophthalmoscope, Keeler Instruments, Inc., Broomall, PA 19008
- Recall number
- Z-1132-2008
- Recalling firm
- Keeler Instruments Inc
- Product
- Keeler All Pupil II Indirect Ophthalmoscope, Keeler Instruments, Inc., Broomall, PA 19008
- Status
- Terminated
- Initiated
- 2008-01-08
- Posted
- 2008-05-22
- Terminated
- 2008-08-12
- Reason
- Good Manufacturing Practices (GMP) deficiencies may compromise the safety and effectiveness of the device. Firm is on import alert 89-04 and released product.
- Root cause
- Process design
- Action
- Keeler Instruments issued an email dated 1/8/08 to the distributor requesting that they return the product.
- Quantity
- 25 units
- Distribution
- The products were shipped to a distributor in NJ.
- Lot, serial or model codes
- Serial numbers: 86249, 85806, 85598, 85601, 86390, 67321, 85600, 85697, 86372, 86394, 85599, 85602, 66378, 85814, 86392, 85605, 66886, 66708, 86255, 85565, 85556, 85558, 85562, 86370, and 66882.
- 510(k) numbers
- ["K854244"]
- PMA numbers
- not on file
- Product code
- HLI
- Firm FEI
- 2519784
- Firm city
- Broomall
- Firm state
- PA
- 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