CLASS II Device recall · Reported 9 Jul 2014 · FDA Enforcement Report
Integra¿ LED Battery Charger, Single Bay recalled
Integra LifeSciences is recalling Integra¿ LED Battery Charger, Single Bay, distributed nationwide in the US. The recall was initiated on 11 Jun 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1976-2014
- FDA event ID
- 68519
- Recalling firm
- Integra LifeSciences, Plainsboro, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jun 2014
- FDA classified
- 1 Jul 2014
- Reported
- 9 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 11 Jun 2014 | Recall initiated by company | |
| 1 Jul 2014 | Classified by FDA | +20 days |
| 9 Jul 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
LED battery chargers may prematurely fail and will not charge the LED battery as intended
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
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.
Questions about this recall
Is Integra¿ LED Battery Charger, Single Bay recalled?
Yes. Integra LifeSciences recalled Integra¿ LED Battery Charger, Single Bay on 11 Jun 2014. The recall is Class II and its status is Terminated. Recall number Z-1976-2014.
Why was it recalled?
LED battery chargers may prematurely fail and will not charge the LED battery as intended
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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