CLASS II ONGOING Device recall · Reported 13 Sep 2023 · FDA Enforcement Report
Olympus Distal Attachment (in Olympus Disposable EMR Kit) recalled
Aomori Olympus is recalling Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the, distributed nationwide in the US. The recall was initiated on 27 Jul 2023 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-2522-2023
- FDA event ID
- 92784
- Recalling firm
- Aomori Olympus, Kuroishi, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Jul 2023
- FDA classified
- 7 Sep 2023
- Reported
- 13 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 27 Jul 2023 | Recall initiated by company | |
| 7 Sep 2023 | Classified by FDA | +42 days |
| 13 Sep 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
Product as listed by the FDA
Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
Which lots are affected?
(1)K-001: Lot Numbers: 5835330 0XI, 0YI, 12I, 14I, 15I, 16I, 17I, 26K, 27K, 28K, 29K, 2XK, 2YK, 2ZK, 31K, 32K. UDI: 4953170048562 (2) K-002 Lot Numbers: 5835430 0XI, 0YI, 12I, 13I, 14I, 16I, 17I, 27K, 2XK, 2YK, 2ZK 4953170048579 K-003 5835530 0XI, 0YI, 12I, 13I, 14I, 15I, 16I, 17I, 25K, 26K, 27K, 28K, 29K, 2XK, 2YK, 2ZK UDI:4953170048586 (3)K-004 Lot Numbers: 5835630 16I, 17I, 26K UDI: 4953170048593 (4)K-011 Lot Numbers: N2485230 0XI, 15I, 17I UDI: 4953170214035 (5) K-012 Lot Numbers: N2485330 16I, 17I UDI: 4953170214042
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
1 other product · FDA event 92784| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Reusable distal attachments recalled by Aomori Olympus Co | Aomori Olympus | Other | Nationwide |
More recalls from Aomori Olympus
All 113| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Reusable distal attachments recalled by Aomori Olympus Co | Aomori Olympus | Other | Nationwide |
| Device | CLASS II | Na-201sx-4021 Aspiration Needle Vizishot recalled by Aomori Olympus Co | Aomori Olympus | Sterility | Nationwide |
| Device | CLASS II | Injector Forcemax Lower recalled by Aomori Olympus Co | Aomori Olympus | Sterility | Nationwide |
| Device | CLASS II | Injector Forcemax Up 2.8mmch recalled by Aomori Olympus Co | Aomori Olympus | Sterility | Nationwide |
| Device | CLASS II | Needlemaster 4MMx Upper recalled by Aomori Olympus Co | Aomori Olympus | Sterility | Nationwide |
Other Surgical Instruments recalls
All 3,883| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hopkins Telescope 30¿ recalled by Karl Storz Endoscopy | Karl Storz Endoscopy | Packaging Defects | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 24" X 4" 1-Line, Yellow recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Mpr Single Use Tourniquet Cuff 15" 1 Line recalled by ASP Global | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Expressaire Disposable Tourniquet Cuff, 12" X 3.5" 1-Line (CS Plum recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 44" X 4" 2-Line, Green recalled | ASP Global | Device Malfunction | Nationwide |