Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638...
FDA Device Recall #Z-1852-2021 — Class II — April 21, 2021
Recall Summary
| Recall Number | Z-1852-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 21, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Anodyne Surgical |
| Location | Saint Charles, MO |
| Product Type | Devices |
| Quantity | 8452 units |
Product Description
Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300
Reason for Recall
The product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of IL, NJ, TX, MO, CA, PA, WA, and the country of Canada.
Lot / Code Information
REF 7018, Lot Numbers: 201157-08 REF AS-7638, Lot Numbers: 210071-001, 210071-002 REF 7018NS, Lot Numbers: 210143-002 REF K20-3168, Lot Numbers:201108-005, 201108-017, 201108-018, 201154-007 REF 104910, Lot Numbers: 201144-002, 2010006-02, 210039-002, 210070-0001, 210080-01, 210127-001 REF CA7800, Lot Numbers: 201067-003, 201068-020 REF AX14784-BULK, Lot Numbers: 200580-006 REF RX2300NS, Lot Numbers: 200359-003 REF RX2300, Lot Numbers: 210142-002
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.