CLASS II ONGOING Device recall · Reported 1 Apr 2026 · FDA Enforcement Report

Olympus Endoscope Suction Valve - MAJ recalled

Olympus Corporation of the Americas is recalling Olympus Endoscope Suction Valve - MAJ-1443, distributed nationwide in the US. The recall was initiated on 12 Feb 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: MAJ-1443. UDI-DI: 04953170355912. Catalog Number: N5363430. All Lot/Serial Numbers.

Quantity recalled47,383 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-1610-2026
FDA event ID: 98371
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 12 Feb 2026
FDA classified: 20 Mar 2026
Reported: 1 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

12 Feb 2026	Recall initiated by company
20 Mar 2026	Classified by FDA	+36 days
1 Apr 2026	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

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

Product as listed by the FDA

Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is Olympus Endoscope Suction Valve - MAJ-1443 recalled?

Yes. Olympus Corporation of the Americas recalled Olympus Endoscope Suction Valve - MAJ-1443 on 12 Feb 2026. The recall is Class II and its status is Ongoing. Recall number Z-1610-2026.

Why was it recalled?

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

Which lots are affected?

Model Number: MAJ-1443. UDI-DI: 04953170355912. Catalog Number: N5363430. All Lot/Serial Numbers.

Where was it sold?

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

More recalls from Olympus Corporation of the Americas

All 415

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Powerseal (in diameter) (long), Curved Jaw Sealer & Divider recalled	Olympus Corporation of the Americas	Labeling Errors	Nationwide
29 Jul 2026Device	CLASS II	Olympus 4K UHD LCD Monitor recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide
29 Jul 2026Device	CLASS II	Olympus High Flow Insufflation Unit - UHI recalled	Olympus Corporation of the Americas	Other	Nationwide
22 Jul 2026Device	CLASS II	Olympus Toomey Evacuator 50cc with Adaptor recalled	Olympus Corporation of the Americas	Sterility	Nationwide
22 Jul 2026Device	CLASS II	Olympus Glass Body for 194 Ellik Evacuator recalled	Olympus Corporation of the Americas	Foreign Material	Nationwide

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	Lead & Heavy Metals	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	Sterility	Nationwide