Recall Z-1472-2024 ยท EOQ Bronchoscope (Flexible Or Rigid)
Karl Storz Endoscopy
Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only
| Date | Apr 3, 2024 (initiated Feb 27, 2024) |
| Status | Open, Classified |
| Reason | Inadequate reprocessing validation evidence |
| Root cause | Under Investigation by firm |
| Action | On March 4, 2024, Karl Storz issued a "Urgent: Medical Device Recall" via UPS. Karl Storz asked 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 products listed above (Table 1) and all other persons who need to be aware within your organization. 3. If you have or may have distributed the products listed, please identify and promptly notify those recipients, or provide KARL STORZ a list of customers who received/may have received the products liste |
| Quantity | 190 units |
| Distribution | US Nationwide distribution in the states of AR, CA, CO, CT, DC, FL, GA, IA, IL, LA, MA, MI, MN, MO , ND, NY, OH, OR, SD, TN, TX, UT, VA, WA, WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K954797 | KARL STORZ RHINO-LARYNGO-BRONCHO FIBERSCOPE, FIBERSCOPE FOR BRONCHOSCOPY KARL STORZ Endoscopy-America, Inc., Jan 17, 1996 |