Quick Facts at a Glance
- Recall Date
- February 25, 2026
- Hazard Level
- HIGH
- Brand
- Olympus Corporation of the Americas
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Olympus Corporation of the Americas
- Product type
- Laparoscopic Cutting Forceps
- Model numbers
- Model: HACF0533, UDI: 00821925036390, Lot Numbers: All unexpired
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 25, 2026
Reported by FDA DEVICE
April 1, 2026
RecallRadar source check
April 8, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
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
About This Product
HALO PKS Cutting Forceps are designed to pass through a 5 mm laparoscopic cannula and are used with electrosurgical energy under laparoscopic visualization.
Why This Is Dangerous
Defective welds can cause the jaw to break during surgical use, potentially compromising patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals may need to halt use of affected tools and arrange replacements, causing procedural delays and procurement steps.
Practical Guidance
How to identify if yours is affected
- Verify model HACF0533 and UDI 00821925036390 on packaging or instrument labels.
- Confirm lot numbers and expiration status; only unexpired lots are affected.
- Inspect for any signs of jaw damage or weld discontinuities before any use.
Where to find product info
Model HACF0533 and UDI 00821925036390 are printed on device labels, packaging, and recall communications.
What timeline to expect
Remedy processing timelines are not specified; follow Olympus’ instructions for replacement or disposition.
If the manufacturer is unresponsive
- Document all contact attempts with Olympus
- Escalate to hospital procurement or compliance if responses are delayed
- Consider filing a consumer protection inquiry if the company remains unresponsive
How to prevent similar issues
- When purchasing laparoscopic instruments, verify weld quality and supplier validation records
- Monitor official recall databases and manufacturer notices for updates
- Ensure proper labeling with UDIs on all surgical tools
Documentation advice
Keep copies of the recall notice, model/UDI numbers, photos of the device, and all correspondence related to the recall.
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Product Details
Model HACF0533. UDI 00821925036390. Sold worldwide to hospitals and clinics. No price information provided. All unexpired lot numbers are affected.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Jaw breakage risk due to welding-defect
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Safety Guide
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