Injection Needle — Class II medical device recall Z-0574-2024

Ongoing recall by Karl Storz Endoscopy, reported 2023-12-27, distributed in AK, AR, CA, CO, DC, FL, GA, HI…. The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for

Recall number	`Z-0574-2024`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Karl Storz Endoscopy, El Segundo, CA, United States
Recall initiated	2023-10-24
Classified	2023-12-18
Reported by FDA	2023-12-27
Distributed	AK, 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
Countries outside the US	CA, DE
Quantity	4,470
UPC / GTIN / UDI-DI	`04048551001660`, `04048551195437`, `04048551195444`, `04048551195451`, `04048551195468`, `04048551203842`
Model numbers	`738750`, `738752`, `738756`, `738758`, `810505`, `810506`

Product

Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80 degrees, REF: 738752; Injection Needle, bayonet, 13 cm, REF: 738756; Injection Needle, angular, 13 cm, REF: 738758; Needle, bayonet-shaped, REF: 810505; Needle, Septum, angular, REF: 810506

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0574-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.