Bausch + Lomb Stellaris Elite Vit Cutter Back Cap Separation Recall
Bausch & Lomb is recalling Stellaris Elite 20 GA Vit Cutters because the back cap may separate from the body of the device.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a structural defect in a medical device used during surgery is rated as Severe (4) due to the potential for significant injury.
Plain-English summary
Bausch & Lomb Inc is recalling the Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm. The recall involves 33 cases of the device, which is packaged in sterile pouches. The affected lot numbers are V9400, W1439, and W1467.
The recall was initiated because the back cap separates from the body of the vitrectomy cutter. This defect poses a risk of harm to patients or healthcare providers during use.
Distribution was made to 26 U.S. states and 17 foreign countries. There was government distribution but no military distribution. Users should stop using the affected devices and contact Bausch & Lomb for instructions on return or replacement.
The recalled product
- Product
- Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper.
- Manufacturer
- Bausch & Lomb Inc
- Hazard
- Affected units
- 33
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot numbers V9400
- exp. 11/6/2018
- W1439
- exp. 8/19/2019
- and W1467
- exp. 8/26/2019
- UDI 00757770058891.
Distribution
Part of a larger recall action
This product is one of 13 recalled by Bausch & Lomb Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 13 products in this recall →Related recalls
Same manufacturer · Bausch & Lomb Inc
See all →- HighBausch + Lomb Stellaris Elite Vit Cutter Back Cap Separation Recall
FDA (Devices) · 2018-10-03
- HighBausch + Lomb Stellaris Elite Vit Cutter Recall Due to Cap Separation
FDA (Devices) · 2018-10-03
- HighBausch + Lomb Stellaris Elite Vit Cutter Recall for Back Cap Separation
FDA (Devices) · 2018-10-03
- HighBausch + Lomb Stellaris Elite Vit Cutter Recall for Cap Separation
FDA (Devices) · 2018-10-03
- HighBausch + Lomb Stellaris Elite Vit Cutter Recall Due to Cap Separation
FDA (Devices) · 2018-10-03
Same hazard · structural defect
See all →- SevereSubaru Recalls 2026 Forester and Crosstrek for Ball Joint Defect
NHTSA · 2026-10-19
- Severe
- SevereVolvo Recalls 2025-2026 VNL Trucks for Loose Structural Bolts
NHTSA · 2026-10-15
- Severe
- Severe
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