Spes Medica recalls Tripolar Hooked Stimulation Probes (L=20mm, Reference SI3H0020S2526D) due to possible ethylene oxide sterilization deviations. This affects intraoperative neurological monitoring devices.
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Spes Medica is recalling Tripolar Hooked Stimulation Probes used in surgery for neurological monitoring. The recall is due to possible issues with how the devices were sterilized, which could affect their safety.
The probes may not have been properly sterilized using ethylene oxide, which is a critical step for surgical instruments. If the sterilization process was flawed, the probes could become contaminated or unsafe for use.
Medical professionals using these probes during surgery are likely affected. The risk is highest for those in operating rooms where the probes are used for intraoperative neurological monitoring.
Check for the model number L=20mm, Reference Number SI3H0020S2526D, and lot number SI20F2956I. These probes are used during surgery for neurological monitoring.
Identify the model number L=20mm, Reference Number SI3H0020S2526D, and lot number SI20F2956I to confirm if your probe is affected.
The supplier informed Spes Medica of possible deviations in the ethylene oxide sterilization process, which could affect the safety of the probes.
The recall record does not specify a remedy, so check the product details to see if it matches the recalled model and lot number.
The recall record does not describe a specific injury risk, so the danger level is unknown.
We’ve drafted a message you can send Spes Medica to request your refund or repair — edit it as you like.
Subject: Recall Z-1971-2021 — Spes Medica Spes Medica Hello, I own a Spes Medica that is covered by recall Z-1971-2021 from Spes Medica. 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.
