Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) ...
FDA Device Recall #Z-1699-2023 — Class II — April 20, 2023
Recall Summary
| Recall Number | Z-1699-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 20, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | C.R. Bard Inc |
| Location | Covington, GA |
| Product Type | Devices |
| Quantity | 7427880 devices |
Product Description
Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 50816G, e) REF 50818G, f) REF 53810G, g) REF 53812G, h) REF 53814G, i) REF 53816G, j) REF 53818G, k) REF 53820G
Reason for Recall
Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.
Distribution Pattern
Worldwide
Lot / Code Information
a) REF 50810G, UDI/DI 0 801741137006; Lot Numbers: JUGV1658; b) REF 50812G, UDI/DI 0 801741137013; Lot Numbers: JUGU0844, JUGV1290, JUGW9017; c) REF 50814G, UDI/DI 0 801741137020; Lot Numbers: JUGS1485, JUGT0238, JUGT0980, JUGT1000, JUGT1710, JUGT2735, JUGT3299, JUGT3353, JUGU0874, JUGU1917, JUGU1956, JUGV0295, JUGV0665, JUGV1277, JUGV1682, JUGW0073, JUGW0812, JUGW1444, JUGW1859; d) REF 50816G, UDI/DI 0 801741137037; Lot Numbers: JUGT0239, JUGT0289, JUGT1010, JUGT1690, JUGT2703, JUGT3399, JUGU0783, JUGU1969, JUGU9049, JUGV0317, JUGV0666, JUGV0690, JUGV9055, JUGX9006; e) REF 50818G, UDI/DI 0 801741137044; Lot Numbers: JUGT9170, JUGT9173, JUGU1788; f) REF 53810G, UDI/DI 0 801741136948; Lot Numbers: JUGQ0944, JUGQ3276, JUGT2737, JUGT9167, JUGU9029, JUGU9035, JUGU9038, JUGU9044, JUGU9051, JUGV9053, JUGX1267, JUGX1988; g) REF 53812G, UDI/DI 0 801741136955; Lot Numbers: JUGQ0939, JUGQ3264, JUGR1444, JUGR2031, JUGS0633, JUGS2403, JUGS3215, JUGT1012, JUGT1711, JUGT2705, JUGT3400, JUGU0845, JUGU1919, JUGV0667, JUGV1292, JUGV9148, JUGW0794; h) REF 53814G, UDI/DI 0 801741136962; Lot Numbers: JUGQ3265, JUGR0224, JUGR1388, JUGR2051, JUGS0048, JUGS0610, JUGS1399, JUGS2381, JUGS3219, JUGT0299, JUGT1019, JUGT1691, JUGT2738, JUGT3301, JUGT3356, JUGU0875, JUGU1905, JUGU1971, JUGV0296, JUGV0692, JUGV1279, JUGV1681, JUGW0814; i) REF 53816G, UDI/DI 0 801741136979; Lot Numbers: JUGQ3277, JUGR1380, JUGR1882, JUGR1883, JUGR2032, JUGR9053, JUGR9056, JUGS2404, JUGT1013, JUGT1712, JUGT2706, JUGT3401, JUGU0846, JUGU1957, JUGV1293, JUGV1659, JUGV9056, JUGW0044, JUGW1861; j) REF 53818G, UDI/DI 0 801741136986; Lot Numbers: JUGR9043, JUGR9057, JUGU9050, JUGV9024, JUGV9048; k) REF 53820G, UDI/DI 0 801741136993 Lot Numbers: JUGR9001, JUGR9002, JUGV1660, JUGX1268, JUGX1989
Other Recalls from C.R. Bard Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0906-2026 | Class II | BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr... | Nov 6, 2025 |
| Z-0908-2026 | Class II | BD InLay Optima Ureteral Stent Kit Size: 8 Fr. ... | Nov 6, 2025 |
| Z-0907-2026 | Class II | BD InLay Optima Ureteral Stent Kit Size: 6 Fr. ... | Nov 6, 2025 |
| Z-0905-2026 | Class II | Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral... | Nov 6, 2025 |
| Z-2589-2025 | Class II | SureStep Foley Tray System Bardex I.C. Complete... | Jul 17, 2025 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
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.