FDA Device Intelligence
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Battery, Replacement, Rechargeable

FDA product code MOQ · Class 1 · General, Plastic Surgery

459
Registered devices
4,301
Adverse events
6
Recalls
3
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2024-09-23Pro-Dex IncThe packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.
2016-01-15The Anspach Effort, Inc.The device is reported to enter safe mode and is no longer able to charge batteries.
2015-12-23Pro-Dex IncThe sterile battery may contain particulates within the sterile package.
2015-12-23Pro-Dex IncThe sterile battery may contain particulates within the sterile package.
2015-11-25The Anspach Effort, Inc.Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, REV" instead of "ON, LOCK, ON".
2006-09-28Lumiport, LLCIncorrect charger; batteries may overheat , catch fire or explode while being charged with the charger enclosed with the device.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.