Bausch & Lomb Stellaris Elite 25 GA Vit Cutter Recall: Back Cap Separates

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Recalling firmBausch & Lomb Inc3365 Tree Court Industrial Blvd · Saint Louis, MO 63122-6615

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Bausch & Lomb is recalling its Stellaris Elite 25 GA Vit Cutters (Model BL5628) because the back cap can separate from the device during use. This separation could lead to injury if the cutter is used without the cap securely attached.

Why it’s dangerous

The back cap can separate from the vitrectomy cutter during use, potentially causing the device to malfunction. This malfunction could lead to injury if the cutter is not properly secured to the surgical site.

Who’s affected

Surgical professionals who use the Bausch & Lomb Stellaris Elite 25 GA Vit Cutter (Model BL5628) are most at risk. Patients undergoing eye surgery with this device may be affected if the back cap separates.

How to tell if you have this one

Check for the model number BL5628 on the device. The product was sold with lot numbers V9301 through W1675, with expiration dates up to September 24, 2019.

Brand
Bausch & Lomb
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device for Cap Separation
Inspect the back cap to ensure it is securely attached to the cutter body. If it separates, stop using the device immediately.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The back cap can separate from the vitrectomy cutter during use, which could lead to injury if the device is not properly secured.

What model numbers are affected?

Model BL5628 with lot numbers V9301, V9401, V9708, W1019, and W1675.

How can I tell if my product is recalled?

Check for the model number BL5628 and lot numbers V9301 through W1675 on the device packaging or label.

Take action

Contact Bausch & Lomb

We’ve drafted a message you can send Bausch & Lomb to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-3271-2018 — Bausch & Lomb Bausch & Lomb

Hello,

I own a Bausch & Lomb that is covered by recall Z-3271-2018 from Bausch & Lomb.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-3271-2018 (August 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3271-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Bausch & Lomb Inc recalls Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.

Use caution until it’s fixed