CLASS II Device recall · Reported 17 Feb 2021 · FDA Enforcement Report
Needlemaster 5MMx Upper recalled by Aomori Olympus Co
Aomori Olympus Co is recalling Needlemaster 5MMx Upper, 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
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-1034-2021
- 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
- Heart & Vascular Devices
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
NEEDLEMASTER 5MMx 21G UPPER, model no. NM-610L-0521 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Where it was distributed
US Nationwide distribution.
Stores named: Walmart
Questions about this recall
Is Needlemaster 5MMx Upper recalled?
Yes. Aomori Olympus Co recalled Needlemaster 5MMx Upper on 4 Jan 2021. The recall is Class II and its status is Terminated. Recall number Z-1034-2021.
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, 05K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 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 |
|---|---|---|---|---|---|
| Device | CLASS II | Reusable distal attachments recalled by Aomori Olympus Co | Aomori Olympus Co | Other | Nationwide |
| Device | CLASS II | Olympus Distal Attachment (in Olympus Disposable EMR Kit) recalled | Aomori Olympus Co | Other | Nationwide |
| Device | CLASS II | Na-201sx-4021 Aspiration Needle Vizishot recalled by Aomori Olympus Co | Aomori Olympus Co | Sterility | Nationwide |
| Device | CLASS II | Injector Forcemax Lower recalled by Aomori Olympus Co | Aomori Olympus Co | Sterility | Nationwide |
| Device | CLASS II | Injector Forcemax Up 8mmch recalled by Aomori Olympus Co | Aomori Olympus Co | Sterility | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |