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

B7-2C Balloon Catheter dia recalled by Aomori Olympus Co

Aomori Olympus is recalling B7-2C Balloon Catheter dia 2.8, 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
Quantity recalled7,400,000 (global); 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-0963-2021
FDA event ID
87074
Recalling firm
Aomori Olympus, 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

Timeline

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

B7-2C BALLOON CATHETER 13mm dia 2.8; model no. B7-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

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

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 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

100 other products · FDA event 87074

This product is part of a recall event; the main page for the event is Injector Forcemax recalled by Aomori Olympus Co.

ReportedClassRecallCompanyReasonWhere
CLASS IIInjector Forcemax recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIKd- Electrosurgical Knife recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIK-202 Guide Sheath Kit recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINeedlemaster 3MMx Lower recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IISd-230u-20 Electrosurgical Snare recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIB7-2la Balloon Catheter Dia recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Up 2.8mmch recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Up 2.8mmch recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Up 2.8mmch recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIPr-v614m 2-lumen Cannula recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIKd-620ur Electrosurgical Snare recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Lower recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Lower recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIB-v233p-a 3-lumen Extraction Balloon V recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Up 2.8mmch recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Sif recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Up 2.8mmch recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINa-401d-1321 Aspiration Needle recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIKd-655u Electrosurgical Snare recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINa-201SX-4022-B Aspiration Needle ViziShot recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Up 2.8mmch recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINeedlemaster 3MMx Lower recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Sif recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINeedlemaster 6MMx Lower recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINeedlemaster 5MMx Upper recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIK-203 Guide Sheath Kit recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Lower recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Lower recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIK-204 Guide Sheath Kit recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Sif recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIKd-620lr Electrosurgical Snare recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIMaj- Use Replacement Basket recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Up 2.8mmch recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IISd-240u-15 Electrosurgical Snare recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIK-203 Guide Sheath Kit recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIPbd-203-0703 Biliary Stent recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINeedlemaster 5MMx Upper recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIK-201 Guide Sheath Kit recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Up 2.8mmch recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Lower recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIB5-2c Balloon Catheter Dia recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIK-201 Guide Sheath Kit recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Lower recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIKd- Electrosurgical Snare recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINa-401d-1521 Aspiration Needle recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIPbd-203-0707 Biliary Stent recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Up 2.8mmch recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINeedlemaster 3MMx Lower recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Lower recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIPbd-203-0710 Biliary Stent recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IISd-240u-25 Electrosurgical Snare recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINa-200h-8022 Ezshot Aspiration Needle recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIK-204 Guide Sheath Kit recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIB5-2q Balloon Catheter recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIK-202 Guide Sheath Kit recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIB7-2q Balloon Catheter Dia recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Up 2.8mmch recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIKd- Electrosurgical Snare recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIPbd-203-0704 Biliary Stent recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINeedlemaster 5MMx Lower recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Up Ch recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Lower 5/bx recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Up 2.8mmch recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINa-201sx-4022-aspiration Needle Vizishot recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINa-201SX-4022-C Aspiration Needle ViziShot w/o stylet recalledAomori OlympusSterilityNationwide
CLASS IISd-210u-15 Electrosurgical Snare, Sd-210u recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IISd-400U-15 Snaremaster Plus Hot/Cold 15m recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Lower recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IISd-210u-25 Electrosurgical Snare, Sd-210u recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINeedlemaster 4MMx Upper recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINa-411d-1321 Aspiration Needle recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIMaj- Use Replacement Basket recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Up 2.8mmch recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINa-601d-1519 Aspiration Needle recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Lower recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIB-v443q-a 3-lumen Extraction Balloon V recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Lower recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IICrescent Snare recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINeedlemaster 3MMx Lower recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IISd-240u-10 Electrosurgical Snare recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINeedlemaster 4MMx Lower recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Up Ch recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIKd- Electrosurgical Snare recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIKd-650u Electrosurgical Snare recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINeedlemaster 4MMx Upper recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINeedlemaster 4MMx Upper recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Up Ch recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIKd-612u Electrosurgical Snare recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINeedlemaster 6MMx Upper recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIKd- Electrosurgical Knife recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINeedlemaster 6MMx Lower recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINeedlemaster 4MMx Lower recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Lower recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IISd-400U-10 Snaremaster Plus Hot/Cold 10m recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINeedlemaster 6MMx Upper recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINeedlemaster 1.8MMx Lower recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Up 2.8mmch recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINeedlemaster 6MMx Upper recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IIInjector Forcemax Up Ch recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
CLASS IINeedlemaster 4MMx Lower recalled by Aomori Olympus CoAomori OlympusSterilityNationwide

More recalls from Aomori Olympus

All 113
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIReusable distal attachments recalled by Aomori Olympus CoAomori OlympusOtherNationwide
DeviceCLASS IIOlympus Distal Attachment (in Olympus Disposable EMR Kit) recalledAomori OlympusOtherNationwide
DeviceCLASS IINa-201sx-4021 Aspiration Needle Vizishot recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
DeviceCLASS IIInjector Forcemax Lower recalled by Aomori Olympus CoAomori OlympusSterilityNationwide
DeviceCLASS IIInjector Forcemax Up 2.8mmch recalled by Aomori Olympus CoAomori OlympusSterilityNationwide

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