FDA Device recall Z-3268-2018
Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/shipper
- FDA Device
- Class II
- terminated
- Published 2018-10-03
On 2018-10-03 the FDA classified a Class II recall of Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/shipper by Bausch And Lomb, citing the back cap separates from the body of the vitrectomy cutter.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3268-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-08 |
| Published | 2018-10-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Bausch And Lomb |
| Distribution | AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, WV |
Product
Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/shipper.
Reason
The back cap separates from the body of the vitrectomy cutter.
Identifiers
| code_info | Lot numbers V9300, exp. 10/17/2018; V9807, exp. 1/7/2019; W0019, exp. 2/5/2019; and W1468, exp. 8/26/2019, UDI 00757770058907. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3268-2018%22
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