Karl Storz Endoscopy recalls curved and straight 23cm injection needles (REFs 8598A/B/D) due to potential infection risk from inadequate cleaning during surgery. Affected items may expose patients to higher infection risks if used without proper cleaning.
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
Karl Storz Endoscopy is recalling curved and straight 23 cm injection needles (model numbers 8598A, 8598B, and 8598D) because their manual cleaning process might not work well, increasing the risk of infection for patients during surgery.
The needles' manual cleaning process may not be effective, meaning they could become contaminated with bacteria. If used without proper cleaning, this increases the chance of infections during surgery for patients.
Surgical teams using Karl Storz Endoscopy injection needles for general or visceral surgery are affected. Patients undergoing procedures with these needles face a potential higher infection risk if the needles aren't cleaned properly.
Check for model numbers 8598A (curved), 8598B (straight), or 8598D (distal 45-degree) on the needles. These were sold with lot numbers including 04048551213278, 04048551001462, and 04048551213285.
Identify if your needle is curved (8598A), straight (8598B), or distal 45-degree (8598D) with the specified model numbers.
The manual cleaning process for these needles may not be effective, potentially exposing patients to a higher risk of infection during surgery.
Look for model numbers 8598A (curved), 8598B (straight), or 8598D (distal 45-degree) with lot numbers including 04048551213278, 04048551001462, or 04048551213285.
The recall record does not specify a remedy, so no action is required unless you have concerns about infection risk during surgery.
We’ve drafted a message you can send Karl Storz Endoscopy to request your refund or repair — edit it as you like.
Subject: Recall Z-0575-2024 — Karl Storz Endoscopy Karl Storz Endoscopy Hello, I own a Karl Storz Endoscopy that is covered by recall Z-0575-2024 from Karl Storz Endoscopy. 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.
