Recall Z-1061-2026 ยท GBM Catheter, Urethral
HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
| Date | Jan 12, 2026 (initiated Nov 29, 2025) |
| Status | Open, Classified |
| Reason | Labeling error, Incorrect expiration date |
| Root cause | Labeling Change Control |
| Action | On November 29, 2025, Hangzhou Bever Medical Devices issued a "Medical Device Recall" Notification via E-Mail. Hangzhou asked consignees to take the following actions: 1) Immediately discontinue the distribution of the RTU14F product (Lot Number T21823), and isolate the products of this lot in inventory to avoid incorrect shipment or use. 2) Discard the affected devices in compliance with local, state, and federal medical waste regulations. 3.If no alternative products are available currently, you may contact your sales representative to inquire about temporary alternative devices or solut |
| Quantity | 149310 units |
| Distribution | US Nationwide distribution in the state of GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192468 | Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Ne Hangzhou Bever Medical Devices Co., Ltd., Nov 27, 2019 |