Olympus recalls HALO PKS Cutting Forceps (model HACF0533) due to potential jaw breakage during clinical use from defective welding. Affected units sold with all unexpired lot numbers.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Olympus is recalling HALO PKS Cutting Forceps that could break during surgery due to faulty welding. This risk could cause injury to patients or surgeons if the forceps malfunction during procedures.
Defective welds in the forceps' jaws can break during clinical use, potentially causing injury to the user or patient. The issue stems from inadequate supplier validation of the welding process, which may lead to structural failure under surgical stress.
Surgeons and medical professionals using Olympus HALO PKS Cutting Forceps (model HACF0533) for laparoscopic procedures are most at risk. Patients receiving these procedures may also be affected if the forceps malfunction.
Check for the model number HACF0533 on the product. The HALO PKS Cutting Forceps are sold with all unexpired lot numbers and are intended for laparoscopic procedures through a 5mm cannula.
Look for the model number HACF0533 on the Olympus HALO PKS Cutting Forceps.
Reach out to Olympus Corporation of the Americas for further guidance on the recall.
Olympus identified that the Cutting Forceps contain components with defective welding due to inadequate supplier validation, which can cause the jaw to break during clinical use.
Check the model number on the product. If it matches HACF0533, contact Olympus Corporation of the Americas for guidance.
The official recall notice does not specify a deadline for action.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1641-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1641-2026 from Olympus. 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.
