FDA Device recall Z-0113-2016
MAJ-1606 Instrument Channel Adaptor
- FDA Device
- Class II
- terminated
- Published 2015-10-14
On 2015-10-14 the FDA classified a Class II recall of MAJ-1606 Instrument Channel Adaptor by Olympus, citing small puncture marks in a sterile package for an accessory to an Olympus device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0113-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-11 |
| Published | 2015-10-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Olympus |
| Distribution | US |
Product
MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.
Reason
small puncture marks in a sterile package for an accessory to an Olympus device
Identifiers
| code_info | Models: Part number K10016901 is a package of 10 pieces, Part number K10007072 is a package of 100 pieces Part n…Models: Part number K10016901 is a package of 10 pieces, Part number K10007072 is a package of 100 pieces Part number K10016901: lot numbers 20115441, 20116536, Part number K10007072: lot numbers 20115441, 20116536 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0113-2016%22
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