DeRoyal recalls specific pacemaker ICD packs (lot 57805969 exp 11/1/2026) due to potential serious injury risk. Affected users should contact DeRoyal for details.
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DeRoyal is recalling a specific model of pacemaker ICD pack (lot 57805969 exp 11/1/2026) because it may cause serious injury. This recall affects medical device users who own the specified lot number.
The recall indicates a potential risk of serious injury, but the specific hazard mechanism is not described in the official notice. The hazard is not detailed enough to explain how the issue could occur.
Medical device users who own the DeRoyal PACEMAKER ICD PACK with lot number 57805969 (expired 11/1/2026) are most at risk. This recall targets individuals with specific pacemaker implants.
Check if your DeRoyal PACEMAKER ICD PACK has lot number 57805969 and expires on 11/1/2026. This model was sold with the specified lot number.
Identify if your pacemaker ICD pack has lot number 57805969 and expires on 11/1/2026.
The DeRoyal PACEMAKER ICD PACK with lot number 57805969 (expires 11/1/2026).
The official notice does not specify a remedy.
Contact DeRoyal directly for instructions on next steps.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-0703-2023 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-0703-2023 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.