DeRoyal recalls PACEMAKER ICD PACK model REF 89-10216.06 with lot numbers 57898501 expiring 3/1/2027 due to risk of serious injury.
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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 that could occur during normal use.
The recall states a risk of serious injury but does not specify the exact hazard mechanism. Without clear details on how the injury occurs, the danger level cannot be determined accurately.
People who own or use the DeRoyal PACEMAKER ICD PACK with lot number 57898501 (expiring 3/1/2027) are affected. Those with implanted medical devices are most at risk.
Check for the product model REF 89-10216.06 and lot number 57898501 on the device. The expiration date is 3/1/2027.
Identify the lot number and expiration date on the device to confirm if it is recalled.
Yes, this recall is for the DeRoyal PACEMAKER ICD PACK model REF 89-10216.06.
The expiration date is 3/1/2027.
The recall does not specify a remedy or immediate action, so there is no instruction to stop using it now.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-0681-2023 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-0681-2023 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.
