Olympus DISPOSABLE GRASPING FORCEPS, FG-51D

FDA Device Recall #Z-1122-2022 — Class II — March 31, 2022

Recall Summary

Recall Number Z-1122-2022
Classification Class II — Moderate risk
Date Initiated March 31, 2022
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Olympus Corporation of the Americas
Location Center Valley, PA
Product Type Devices
Quantity 1386 units

Product Description

Olympus DISPOSABLE GRASPING FORCEPS, FG-51D

Reason for Recall

Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps

Distribution Pattern

US Nationwide Distribution

Lot / Code Information

Lot numbers since January 2017. Affected Lot Numbers: 01K 02K 03K 04K 05K 06K 07K 08K 09K 0XK 0YK 0ZK 11H 11K 12K 13K 14K 15K 16K 17K 18K 19K 1XK 71K 72K 73K 74K 75K 76K 77H 77K 78K 79K 7XK 7YK 7ZK 81K 82K 83K 84K 85K 86K 87K 88K 89K 8XK 8YK 8ZK 91K 92K 93K 94K 95K 96K 97K 98K 99K 9XK 9YK 9ZK

Other Recalls from Olympus Corporation of the Americas

Recall # Classification Product Date
Z-1641-2026 Class II Brand Name: Olympus HALO PKS Cutting Forceps, 5... Feb 25, 2026
Z-1640-2026 Class II Brand Name: Olympus PK Cutting Forceps, 5mm 33c... Feb 25, 2026
Z-1642-2026 Class II Brand Name: Olympus PKS Cutting Forceps, 5mm 33... Feb 25, 2026
Z-1639-2026 Class II Brand Name: Olympus Everest Bipolar Cutting For... Feb 25, 2026
Z-1643-2026 Class II Brand Name: Olympus PKS Cutting Forceps w/Cord,... Feb 25, 2026

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.