FDA Medical Device Recalls (openFDA)
Karl Storz Endoscopy: Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
- Recall number
- Z-2589-2023
- Recalling firm
- Karl Storz Endoscopy
- Product
- Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
- Status
- Open, Classified
- Initiated
- 2023-07-07
- Posted
- 2023-09-15
- Terminated
- not on file
- Reason
- Flexible intubation endoscopes sterility assurance can not be confirmed.
- Root cause
- Process change control
- Action
- On August, 4, 2023, Karl Storz Endoscopy issued an Urgent Medical Device Recall Notification via: UPS. Karl Storz asked consignees to take the following actions: 1. Immediately quarantine and discontinue use of Material numbers listed above. 2. Pass on this Urgent Medical Device Recall notice to all users of the products listed above and all other persons who need to be aware within your organization. 3. If you have distributed the products listed, please promptly forward this letter to those recipients, and indicate contact details of the recipient on the Customer Reply From. 4. Return the filled Customer Reply Form by Fax or E-Mail to the indicated contact. 5. Get in touch with your KARL STORZ representative to return affected products. 6. Please report any incidents related to this issue to the manufacturer, dealer, or local representative and, if applicable, to the national competent authority, as this is important feedback. 7. (Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.)
- Quantity
- 218 units
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MEX, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Canada.
- Lot, serial or model codes
- UDI: 04048551446690/ All lots with remaining shelf life (Globally) Lots imported into the U.S.: 500472 & 500461
- 510(k) numbers
- ["K212656"]
- PMA numbers
- not on file
- Product code
- EOQ
- Firm FEI
- 3007475226
- Firm city
- El Segundo
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28