Recall Z-0837-2025 ยท LRC Instrument, Ent Manual Surgical
Karl Storz Endoscopy
Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
| Date | Jan 10, 2025 (initiated Dec 19, 2024) |
| Status | Open, Classified |
| Reason | Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance. |
| Root cause | Reprocessing Controls |
| Action | On December 19, 2024, Karl Storz issued a "Urgent: Medical Device Recall" Notification to affected consignees. In addition to informing consignees about the recall, Karl Storz ask consignees to take the following actions: 1. Immediately quarantine and discontinue use of associated part numbers listed. 2. Pass on this Urgent Medical Device Recall Notice to all users of the recalled product and all other persons who need to be aware within your organization. 3. If you have further distributed the recall product, please identify and promptly notify those recipients by providing a copy of the |
| Quantity | 285 units |
| Distribution | US: AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OR, PA, SC, TX, VA OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.