Integra LED Battery Charger Recalled for Premature Failure
Integra LifeSciences is recalling 1,250 LED battery chargers because they may fail prematurely and not charge the LED battery as intended.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional failure (failure to charge) rather than a direct physical injury or contamination risk, fitting the criteria for moderate severity.
Plain-English summary
Integra LifeSciences Corp. is recalling 1,250 units of the Integra LED Battery Charger, Single Bay (Product Number 90523). This accessory is used with the Integra LED Headlight System to provide illumination during minor surgical, diagnostic, or therapeutic procedures.
The recall was initiated because the battery chargers may prematurely fail and will not charge the LED battery as intended. The affected units were distributed worldwide, including the United States, Canada, Australia, and various countries in Europe, Asia, and the Middle East.
The affected lot numbers are IE123610 through IE125210 and IE130110 through IE131010. Users should stop using the affected chargers and contact the manufacturer for instructions on replacement or refund.
The recalled product
- 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…
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 1,250
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot Numbers: IE123610
- IE123710
- IE123810
- IE123910
- IE124010
- IE124110
- IE124210
- IE124310
- IE124410
- IE124510
- IE124610
- IE124710
- IE124810
- IE124910
- IE125010
- IE125110
- IE125210
- IE130110
- IE130210
- IE130310
Distribution
Distributed nationwide across the United States.
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