Z-1976-2014Class II

Integra LED Battery Charger, Single Bay. Product Number: 90523 The LED Headlight System Battery Charger...

Name: Z-1976-2014 Integra LED Battery Charger, Single Bay. Product Number: 90523 The LED Headlight System Battery Charger...
Creator: Integra LifeSciences Corp.
Published: 2014-06-11
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2014-06-11 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of Integra LED Battery Charger, Single Bay. Product Number: 90523 The LED Headlight System Battery Charger (90523) is an accessory to the LED Headlight System... on 2014-06-11. FDA classified it as Class II and gives the reason as "LED battery chargers may prematurely fail and will not charge the LED battery as intended". 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-1976-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-11
Posted: 2014-07-02
Terminated: 2014-12-19
Recalling firm: Integra LifeSciences Corporation
Product: Integra LED Battery Charger, Single Bay. Product Number: 90523 The LED Headlight System Battery Charger (90523) is an accessory to the LED Headlight System: 90520US - LED Headlight w/Battery & AC/DC Power Supply - US 90520EU - LED Headlight w/Battery & AC/DC Power Supply - EU 90520UK - LED Headlight w/Battery & AC/DC Power Supply - UK 90520AU - LED Headlight w/Battery & AC/DC Power Supply - AU Product Usage: The Integra LED Headlight System Is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures
Product code: HPP Headlamp, Operating, Battery-Operated
Reason for recall: LED battery chargers may prematurely fail and will not charge the LED battery as intended
Root cause tag: manufacturing process
FDA root cause: Manufacturing material removal
Action: Integra initiated a voluntary recall on June 11, 2014 to consignees that have been shipped affected product lots of Integra LED Battery Chargers, Catalogue No. 90523. The written notifications were delivered to US consignees by traceable courier service and non-US consignees by traceable email or facsimile. The consignee notification: Advises them of the nature of the issue and the potential for an adverse patient consequence. Advises them to review their inventory and how to determine if they have affected battery chargers. Advises them to immediately stop the use or distribution of any affected product lot numbers they may have. Requests they identify and report to Integra if they do or do not have any unexpired affected product lots. Advises them replacements battery chargers will be shipped for any affected products they affirm are in their possession and how to return their affected product. Questions regarding these instructions, please contact Integra Customer Service at 1-800-431-1123 or your Integra sales
Quantity in commerce: 1250 battery chargers
Distribution: Worldwide Distribution - US Nationwide and the countries of Canada, Australia, Arab Emirates, Denmark, Germany, Great Britain, India, Ireland, Israel, Japan, Kuwait, Lebanon, Malta., Netherlands, Panama, Poland, Saudi Arabia, Singapore, South Africa, Spain, Sweden, and Tunisia.
Product codes and lots: Lot Numbers: IE123610, IE123710, IE123810, IE123910, IE124010, IE124110, IE124210, IE124310, IE124410, IE124510, IE124610, IE124710, IE124810, IE124910, IE125010, IE125110, IE125210, IE130110, IE130210, IE130310, IE130410, IE130510, IE130610, IE130710, IE130810, IE130910, IE131010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1976-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1976-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01

Product code HPP

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)