RecallRadar

FDA Device recall Z-0572-2024

Injection Needle, 3 Fr., REF: 27030N

On 2023-12-27 the FDA classified a Class II recall of Injection Needle, 3 Fr., REF: 27030N by Karl Storz Endoscopy, citing 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 p….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0572-2024
ClassificationClass II
Statusongoing
Initiated2023-10-24
Published2023-12-27
Last updated2026-09-13 11:56 UTC
CompanyKarl Storz Endoscopy
DistributionAK, AR, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, VA, VT, WA, WI, WV

Product

Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A

Reason

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.

Identifiers

code_infoREF/UDI-DI: 27030N/4048551257180, 27182A/4048551081457 All lot numbers.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0572-2024%22

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