Hobbs Medical Polypectomy Snare, Catalog No. 7202
FDA Device Recall #Z-1388-2022 — Class II — June 3, 2022
Recall Summary
| Recall Number | Z-1388-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 3, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Hobbs Medical, Inc. |
| Location | Stafford Springs, CT |
| Product Type | Devices |
| Quantity | 45 (US) |
Product Description
Hobbs Medical Polypectomy Snare, Catalog No. 7202
Reason for Recall
During use, the sheath of the device may accordion at the proximal end where the sheath meets the shrink band. Kinking of the sheath may prevent the snare from fully closing, and injury may result.
Distribution Pattern
Domestic distribution to NC, TX, and WA. Foreign distribution to Canada.
Lot / Code Information
UDI-DI: M84972020 Package UDI: M84972021 Lots: H11-20-017 H04-20-062 H04-19-056 H11-19-077 H08-17-014R H10-17-089R H10-17-089 H0S-17-014 H06-17-167
Other Recalls from Hobbs Medical, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0472-2025 | Class II | Posi-Stop Injection Needle, 23 Gauge, Catalog N... | Oct 4, 2024 |
| Z-0470-2025 | Class II | Posi-Stop Injection Needle, 23 Gauge, Catalog N... | Oct 4, 2024 |
| Z-0474-2025 | Class II | Posi-Stop Injection Needle, 25 Gauge, Catalog N... | Oct 4, 2024 |
| Z-0475-2025 | Class II | Posi-Stop Injection Needle, 25 Gauge, Catalog N... | Oct 4, 2024 |
| Z-0471-2025 | Class II | Posi-Stop Injection Needle, 23 Gauge, Catalog N... | Oct 4, 2024 |
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.