Medline Eye and Cataract Kits Recalled for Potential Sterility Breach
Medline is recalling 2,080 eye and cataract preop kits due to packaging defects that may compromise sterility, posing a risk of microbial contamination.
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 source text explicitly states that potential health consequences include hospitalization and that severe infection could become life-threatening, which aligns with the rubric criteria for a score of 4 (Severe) involving significant injury or hospitalization reports.
Plain-English summary
Medline Industries, LP is recalling 2,080 units of Eye Kits and Cataract Preop Kits distributed nationwide in the United States. The affected products include specific model numbers and lot numbers of EYE KIT and CATARACT PREOP KIT convenience kits.
The recall was initiated because the kits contain BD ChloraPrep Clear and FREPP Clear applicators that have a potential breach of sterility in the packaging. Wrinkles in the paper lidding may extend to the seal area, which could compromise the sterile barrier. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination.
Potential health consequences range from no injury to localized infection or more serious infections requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly for critically ill or immunocompromised patients, severe infection could become life-threatening. Consumers should check their inventory for the specific model numbers and lot numbers listed in the recall notice and stop using the affected kits.
The recalled product
- Product
- Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, Model Number: DYKM2751A; 3) CATARACT PREOP KIT, Model Number: DYKS1583A; 4) CATARACT PREOP KIT, Model Number: DYKS1583B
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 2,080
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 (20)
- 1) DYKM2751
- UDI-DI: 10198459118395(each)
- 40198459118396(case)
- Lot Number: 24LBQ727
- 2) DYKM2751
- Lot Number: 24JBB775
- 3) DYKM2751A
- UDI-DI: 10198459313301(each)
- 40198459313302(case)
- Lot Number: 25KMD727
- 4) DYKS1583A
- UDI-DI: 10198459146640(each)
- 40198459146641(case)
- Lot Number: 24KBP388
- 5) DYKS1583A
- Lot Number: 24JBA739
- 6) DYKS1583B
- UDI-DI: 10198459292699(each)
- 40198459292690(case)
- Lot Number: 25DBM037
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Medline Industries, LP
See all →- ModerateMedline Recalls Convenience Kits Containing CONMED AirSeal Access Ports
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to overpressure alerts
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alerts
FDA (Devices) · 2026-10-21
- SevereMedline surgical kits recalled for non-conforming cannula components
FDA (Devices) · 2026-10-21
Same hazard · microbial contamination
See all →- SevereMedtronic Recalls Grafton DBM Allografts Due to Donor Microbial Presence
FDA (Devices) · 2026-10-21
- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- CriticalOptimal Balance Pharmacy Recalls Contaminated Glutathione Injection Vials
FDA (Drugs) · 2026-09-09
Similar recalls
- HighMedline Pre-Op Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Colorectal Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline C-Section Prep Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Arterial Line Insertion Kits Recalled for Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Recalls Cataract Preop Kits with Potentially Contaminated Applicators
FDA (Devices) · 2026-09-09