Z-1132-2008

Keeler All Pupil II Indirect Ophthalmoscope, Keeler Instruments, Inc., Broomall, PA 19008

Name: Z-1132-2008 Keeler All Pupil II Indirect Ophthalmoscope, Keeler Instruments, Inc., Broomall, PA 19008
Creator: Keeler Instruments Inc
Published: 2008-01-08
License: https://open.fda.gov/license/

Keeler Instruments, Inc. / initiated 2008-01-08 / Terminated / root cause: manufacturing process

FDA source

Keeler Instruments Inc began a recall of Keeler All Pupil II Indirect Ophthalmoscope, Keeler Instruments, Inc., Broomall, PA 19008 on 2008-01-08. The reason FDA records is "Good Manufacturing Practices (GMP) deficiencies may compromise the safety and effectiveness of the device. Firm is on import alert 89-04 and released product". 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-1132-2008
Status: Terminated
Initiated: 2008-01-08
Posted: 2008-05-22
Terminated: 2008-08-12
Recalling firm: Keeler Instruments, Inc.
Product: Keeler All Pupil II Indirect Ophthalmoscope, Keeler Instruments, Inc., Broomall, PA 19008
Product code: HLI Ophthalmoscope, Ac-Powered
Reason for recall: 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 tag: manufacturing process
FDA root cause: Process design
Action: Keeler Instruments issued an email dated 1/8/08 to the distributor requesting that they return the product.
Quantity in commerce: 25 units
Distribution: The products were shipped to a distributor in NJ.
Product codes and lots: 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.

Product code HLI

K854244Class IIThe Keeler All Pupil Indirect OphthalmoscopeKeeler Instruments, Inc. / cleared 1985-11-12

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)