Karl Storz Endoscopy: Medical Device Recall in 2023 - (Recall #: Z-0575-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-degrees, 23 cm, REF: 8598D

Product Classification:

Class II

Date Initiated: October 24, 2023

Date Posted: December 27, 2023

Recall Number: Z-0575-2024

Event ID: 93328

Reason for Recall:

The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.

Status: Ongoing

Product Quantity: 4,878

Code Information:

REF/UDI-DI: 8598A/04048551213278, 8598B/04048551001462, 8598D/04048551213285 All lot numbers.

Distribution Pattern:

US: MI, NH, SC, PA, FL, NY, NC, MS, MO, CA, NJ, IL, NV, OK, CO, OH, WA, WI, VA, IN, IA, AR, TX, WV, MD, MN, GA, MA, NM, VT, AK, OR, ID, LA, KS, DC, KY, HI OUS: Mexica, Canada, Germany

Voluntary or Mandated:

Voluntary: Firm initiated