Z-0977-03

Papsure, Speculite, Disposable light for vaginal illumination. 10 packets per box

Name: Z-0977-03 Papsure, Speculite, Disposable light for vaginal illumination. 10 packets per box
Creator: Watson Diagnostics Inc.
Published: 2003-08-07
License: https://open.fda.gov/license/

Watson Diagnostics Inc. / initiated 2003-08-07 / Terminated

FDA source

Watson Diagnostics Inc. began a recall of Papsure, Speculite, Disposable light for vaginal illumination. 10 packets per box on 2003-08-07. The reason FDA records is "Lights split, spilling contents when bent to activate". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0977-03
Status: Terminated
Initiated: 2003-08-07
Posted: 2003-08-26
Terminated: 2007-12-14
Recalling firm: Watson Diagnostics Inc.
Product: Papsure, Speculite, Disposable light for vaginal illumination. 10 packets per box.
Product code: MPU Source, Chemiluminescent Light
Reason for recall: Lights split, spilling contents when bent to activate.
FDA root cause: Other
Action: Users are instructed to cease use and return the product immediately in a letter issued 8/7/2003 return receipt requested.
Quantity in commerce: 662 boxes
Distribution: Nationwide.
Product codes and lots: Lot numbers 24C06B, 24C06D, 24C06E, 24D04S.

Product code MPU

K963391Class IISpeculiteTrylon Corp. / cleared 1997-12-12

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)