CLASS II ONGOING Device recall · Reported 29 Nov 2023 · FDA Enforcement Report

Hysteroscope-For endoscopic diagnosis within the uterus recalled

Aizu Olympus is recalling Hysteroscope-For endoscopic diagnosis within the uterus, distributed nationwide in the US. The recall was initiated on 25 Sep 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number (UDI-DI): HYF-1T (04953170051128).

Quantity recalled0 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0335-2024
FDA event ID: 93222
Recalling firm: Aizu Olympus, Aizuwakamatsu, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 25 Sep 2023
FDA classified: 17 Nov 2023
Reported: 29 Nov 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

25 Sep 2023	Recall initiated by company
17 Nov 2023	Classified by FDA	+53 days
29 Nov 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

Product as listed by the FDA

Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.

Where it was distributed

Worldwide - US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Model Number (UDI-DI): HYF-1T (04953170051128).

Where was it sold?

Worldwide - US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

21 other products · FDA event 93222

This product is part of a recall event; the main page for the event is Signmoidovideoscope-For endoscopy recalled by Aizu Olympus Co.

Reported	Class	Recall	Company	Reason	Where
29 Nov 2023	CLASS II	Signmoidovideoscope-For endoscopy recalled by Aizu Olympus Co	Aizu Olympus	Other	Nationwide
29 Nov 2023	CLASS II	Tracheal fiberscope-airway management recalled by Aizu Olympus Co	Aizu Olympus	Other	Nationwide
29 Nov 2023	CLASS II	Gastroscope-endoscopic ultrasound recalled by Aizu Olympus Co	Aizu Olympus	Other	Nationwide
29 Nov 2023	CLASS III	Choleodochoscope. Model Numbers: Chf-BP30, Chf-CB30L, Chf-P60 recalled	Aizu Olympus	Other	Nationwide
29 Nov 2023	CLASS II	Bronchoscope-for endoscopy and endoscopic surgery within recalled	Aizu Olympus	Other	Nationwide
29 Nov 2023	CLASS II	Rhinolaryngoscope-for endoscopic diagnosis recalled by Aizu Olympus Co	Aizu Olympus	Other	Nationwide
29 Nov 2023	CLASS II	Colonoscope-indicated for use within the lower digestive recalled	Aizu Olympus	Other	Nationwide
29 Nov 2023	CLASS II	Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic recalled	Aizu Olympus	Other	Nationwide
29 Nov 2023	CLASS II	Ureteralscope- for endoscopic diagnosis recalled by Aizu Olympus Co	Aizu Olympus	Other	Nationwide
29 Nov 2023	CLASS II	Transnasal esophagovideoscope-For endoscopy recalled by Aizu Olympus Co	Aizu Olympus	Other	Nationwide
29 Nov 2023	CLASS II	Cystonephroscope-endoscopic diagnosis recalled by Aizu Olympus Co	Aizu Olympus	Other	Nationwide
29 Nov 2023	CLASS II	Tracheal videoscope- For airway management recalled by Aizu Olympus Co	Aizu Olympus	Other	Nationwide
29 Nov 2023	CLASS II	Hysterovideoscope-For endoscopic diagnosis within the uterus recalled	Aizu Olympus	Other	Nationwide
29 Nov 2023	CLASS II	Gastrointestinal videoscope-indicated recalled by Aizu Olympus Co	Aizu Olympus	Other	Nationwide
29 Nov 2023	CLASS II	Duodenovideoscope-EndoTherapy accessories recalled by Aizu Olympus Co	Aizu Olympus	Other	Nationwide
29 Nov 2023	CLASS II	Hysterofiberscope-For endoscopic diagnosis within the uterus recalled	Aizu Olympus	Other	Nationwide
29 Nov 2023	CLASS II	Small intestinal videoscope-For endoscopy recalled by Aizu Olympus Co	Aizu Olympus	Other	Nationwide
29 Nov 2023	CLASS II	Colonoscope: for endoscopy and endoscopic surgery within recalled	Aizu Olympus	Other	Nationwide
29 Nov 2023	CLASS II	Ultrasonic gastrovideoscope-Real time ultrasound recalled	Aizu Olympus	Other	Nationwide
29 Nov 2023	CLASS II	Mobile airway scope-diagnosis recalled by Aizu Olympus Co	Aizu Olympus	Other	Nationwide
29 Nov 2023	CLASS II	Uretero-reno fiberscope-For endoscopic diagnosis recalled	Aizu Olympus	Other	Nationwide

More recalls from Aizu Olympus

All 31

Reported	Class	Recall	Company	Reason	Where
10 Dec 2025Device	CLASS II	Olympus OER-Mini recalled by Aizu Olympus Co	Aizu Olympus	Other	Nationwide
10 Dec 2025Device	CLASS II	Olympus OER-Pro recalled by Aizu Olympus Co	Aizu Olympus	Other	Nationwide
10 Dec 2025Device	CLASS II	Olympus OER-Elite recalled by Aizu Olympus Co	Aizu Olympus	Other	Nationwide
6 Dec 2023Device	CLASS II	Gif-hq190, Evis Exera Iii Gastrointestinal Videoscope recalled	Aizu Olympus	Other	6 states
6 Dec 2023Device	CLASS II	Gif-h190, Evis Exera Iii Gastrointestinal Videoscope recalled	Aizu Olympus	Other	6 states

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide