DeRoyal recalls PACEMAKER ICD PACK model REF 89-10216.03 with lot numbers 56705350 expiring 6/1/2026 due to risk of serious injury. Consumers should contact DeRoyal for details.
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DeRoyal is recalling a specific type of pacemaker implantable cardioverter defibrillator (ICD) pack. This recall is due to a risk of serious injury if the device malfunctions. Affected customers should stop using the device and contact DeRoyal for further instructions.
The device may malfunction, leading to serious injury or death. This is a critical issue for individuals with implanted cardiac devices.
Owners of the DeRoyal PACEMAKER ICD PACK with lot number 56705350 (expiring 6/1/2026) are affected. Patients with implanted ICDs are most at risk.
Check for the model reference 89-10216.03 and lot number 56705350 on the device. The device expires on June 1, 2026.
Immediately stop using the DeRoyal PACEMAKER ICD PACK if you have the recalled model.
The recall number is not stated in the official notice.
Check for the model reference 89-10216.03 and lot number 56705350 on the device.
Contact DeRoyal directly for instructions on how to stop using the device.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-0680-2023 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-0680-2023 from DeRoyal. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.