Olympus Corporation of the Americas is recalling 2,648 HALO PKS Cutting Forceps HACF0533 sold to hospitals and clinics worldwide. The jaw can break during surgical use due to a supplier welding-validation issue. Healthcare facilities should stop using the device immediately and follow Olympus recall instructions for disposition.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
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HALO PKS Cutting Forceps are designed to pass through a 5 mm laparoscopic cannula and are used with electrosurgical energy under laparoscopic visualization.
Defective welds can cause the jaw to break during surgical use, potentially compromising patient safety.
This recall is not part of a broader industry pattern.
Hospitals may need to halt use of affected tools and arrange replacements, causing procedural delays and procurement steps.
Model HACF0533 and UDI 00821925036390 are printed on device labels, packaging, and recall communications.
Remedy processing timelines are not specified; follow Olympus’ instructions for replacement or disposition.
Keep copies of the recall notice, model/UDI numbers, photos of the device, and all correspondence related to the recall.
Model HACF0533. UDI 00821925036390. Sold worldwide to hospitals and clinics. No price information provided. All unexpired lot numbers are affected.
No injuries or incidents have been reported.
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