# FDA recall Z-2413-2023

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2023-06-08.

## Product

HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecological applications.    64 Models:  1)		A22201C  2)		A22201D  3)		A22202C  4)		A22203C  5)		A22205C  6)		A22205D  7)		A22206C  8)		A22207C  9)		A22211C  10)		A22221C  11)		A22222C  12)		A22223C  13)		A22231C  14)		A22231D  15)		A22251C  16)		A22253C  17)		A22255C  18)		A22257C  19)		A22258C  20)		A22266C  21)		A44728C  22)		WA22037C  23)		WA22038C  24)		WA22039C  25)		WA22301D  26)	WA22301S  27)	WA22302D  28)	WA22305D  29)	WA22305S  30)	WA22306D  31)	WA22332D  32)	WA22351C  33)	WA22355C  34)	WA22503D  35)	WA22507D  36)	WA22521C  37)	WA22523C  38)	WA22537D  39)	WA22538C  40)	WA22539D  41)	WA22540S  42)	WA22541S  43)	WA22542S  44)	WA22544S  45)	WA22557C  46)	WA22566S  47)	WA22602D  48)	WA22603D  49)	WA22606D  50)	WA22607D  51)	WA22621C	  52)	WA22623C	  53)	WA22632D	  54)	WA22651C	  55)	WA22655C	  56)	WA22657C	  57)	WA47505S	  58)	WA47506S	  59

## Reason for recall

Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved. (2) The second Caution refers to the risk of sparkover when getting in contact with metal parts as this can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2413-2023
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-08
- **Report date:** 2023-08-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2413-2023

## Citation

> AI Analytics. FDA recall Z-2413-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2413-2023. Source: US FDA. Licensed CC0.

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