CLASS II Device recall · Reported 17 Feb 2021 · FDA Enforcement Report

Injector Forcemax Lower recalled by Aomori Olympus Co

Aomori Olympus Co is recalling Injector Forcemax Lower, distributed nationwide in the US. The recall was initiated on 4 Jan 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06, 07V, 08V, 09V, 0XV

Quantity recalled7,400,000 (globally); 260,395 (US)

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-1001-2021
FDA event ID: 87074
Recalling firm: Aomori Olympus Co, Kuroishi, N/A
Classification: Class II
Status: Terminated
Recall initiated: 4 Jan 2021
FDA classified: 5 Feb 2021
Reported: 17 Feb 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

4 Jan 2021	Recall initiated by company
5 Feb 2021	Classified by FDA	+32 days
17 Feb 2021	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

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Where it was distributed

US Nationwide distribution.

Nationwide

Stores named: Walmart

Questions about this recall

Is Injector Forcemax Lower recalled?

Yes. Aomori Olympus Co recalled Injector Forcemax Lower on 4 Jan 2021. The recall is Class II and its status is Terminated. Recall number Z-1001-2021.

Why was it recalled?

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Which lots are affected?

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06, 07V, 08V, 09V, 0XV

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 Aomori Olympus Co

All 113

Reported	Class	Recall	Company	Reason	Where
13 Sep 2023Device	CLASS II	Reusable distal attachments recalled by Aomori Olympus Co	Aomori Olympus Co	Other	Nationwide
13 Sep 2023Device	CLASS II	Olympus Distal Attachment (in Olympus Disposable EMR Kit) recalled	Aomori Olympus Co	Other	Nationwide
17 Feb 2021Device	CLASS II	Na-201sx-4021 Aspiration Needle Vizishot recalled by Aomori Olympus Co	Aomori Olympus Co	Sterility	Nationwide
17 Feb 2021Device	CLASS II	Injector Forcemax Lower recalled by Aomori Olympus Co	Aomori Olympus Co	Sterility	Nationwide
17 Feb 2021Device	CLASS II	Injector Forcemax Up 8mmch recalled by Aomori Olympus Co	Aomori Olympus Co	Sterility	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