Bausch + Lomb Ophthalmic Surgical Kits Recalled for Sterile Packaging Defect
Medline Industries is recalling 800 Bausch + Lomb Basic Ophthalmic surgical kits (Lot 22DBN365) for defective breather pouch seals. Opened seals in the packaging compromise the sterile conditions required for surgical procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall for defective sterile packaging on surgical kits. While no injuries or illnesses have been reported, compromised seal integrity on sterile surgical equipment poses a risk of surgical site contamination, meeting the criteria for High-severity classification per the rubric.
Plain-English summary
Medline Industries is recalling 800 units of the Bausch + Lomb Basic Ophthalmic Pack (Reference LYN023BSBLB, Lot Number 22DBN365) distributed nationwide. The recalled kits were distributed in California, Minnesota, North Carolina, New York, Oklahoma, Pennsylvania, Tennessee, and Texas.
The recall was initiated after Medline received complaints that some breather pouches within the sterile surgical kits show openings in the seal. These seal defects compromise the sterile barrier protection that is essential for surgical use.
Anyone who received these surgical kits should take them out of service. Medline Industries should be contacted regarding replacement options or product return procedures.
The recalled product
- Product
- BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used in surgical procedures.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kit
- Hazard
- seal-defect
- contamination-risk
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 (2)
- GTIN (01) 10889942336241
- Lot Number 22DBN365
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- SevereMedline angiography and radiology convenience kits recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
FDA (Devices) · 2026-07-01
- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- SevereMedical Device Surgical Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01