Surgical Cataract Kits Recalled for Defective Breather Pouch Seals
Medline has recalled Bausch + Lomb cataract surgical kits due to breather pouches with seal openings that could compromise sterility. Affected kits were distributed nationwide.
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 3/5 (High).
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: This is a risk-of-harm product where the hazard—compromised sterile barrier in surgical instruments—is real but no illness or injury has been reported. The defect presents a theoretical risk of surgical site contamination without documented clinical consequences.
Plain-English summary
Medline Industries has recalled Bausch + Lomb Cataract Tray kits (Reference LYN023FACTB) due to breather pouches with openings in the seal. The defect could compromise the sterility of the surgical instruments contained within the kit.
The recall affects 28 kits distributed nationwide across California, Minnesota, North Carolina, New York, Oklahoma, Pennsylvania, Tennessee, and Texas. Affected kits are identified by Lot Number 22DBM506.
Healthcare providers should discontinue use of affected kits immediately and contact Medline for further guidance.
The recalled product
- Product
- BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgical procedures.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Affected units
- 28
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) 10889942339730
- Lot Number 22DBM506
Distribution
Part of a larger recall action
This product is one of 13 recalled by MEDLINE INDUSTRIES, LP - Northfield 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.
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