Medline Eye Surgery Convenience Kits Recalled Due to Weak Seal Risk
Medline is recalling 3,909 ophthalmic surgical convenience kits due to potentially weak or open seals on breather pouches that maintain product sterility. The seal defect could compromise the sterile contents during storage or use.
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: This Class II recall involves a risk-of-harm product—sterile surgical kits—where compromised packaging could jeopardize patient safety through sterility loss during eye surgery. However, no illnesses or injuries have been reported, and the hazard remains theoretical, making this High severity per the rubric.
Plain-English summary
Medline Industries, LP is recalling 3,909 ophthalmic surgical convenience kits distributed worldwide, including to the United States, Canada, Mexico, Panama, and the Virgin Islands. The recalled kits include 31 different models designed for various eye surgical procedures, including cataract surgery, vitrectomy, and ophthalmic plastic surgery procedures.
The recall is due to a potential for open or weak seals on breather pouches used to package the sterile instruments and supplies in these convenience kits. Breather pouches are designed to maintain sterility while allowing air exchange. Compromised seals could allow contamination of the sterile contents, which presents a risk if kits are used in surgical procedures.
The recall affects hospitals, surgical centers, and other healthcare facilities that use these Medline convenience kits for ophthalmic procedures. Specific model numbers and lot numbers are detailed in the FDA recall notice. No illnesses or injuries have been reported as of this recall announcement. Healthcare providers and patients should contact Medline or the FDA for instructions on verification and replacement of affected products.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number: DYNJ41097A; 2) PK EYE, Model Number: DYNJ60631B; 3) CATARACT PACK, Model Number: DYNJ80316A; 4) BASIC EYE PACK, Model Number: DYNJ63707C; 5) EYE PACK WITH ACCESSORY PACK, Model Number:
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- weak-seal
- compromised-sterility
- packaging-defect
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) DYNJ41097A
- UDI-DI: 10888277213487(each)
- 40888277213488(case)
- Lot Number: 24IBF244
- 2) DYNJ60631B
- UDI-DI: 10193489994421(each)
- 40193489994422(case)
- Lot Number: 24IBG352
- 3) DYNJ80316A
- UDI-DI: 10195327245221(each)
- 40195327245222(case)
- Lot Number: 24IBG593
- 4) DYNJ63707C
- UDI-DI: 10193489883503(each)
- 40193489883504(case)
- Lot Number: 24IBH027
- 5) DYNJ85284
- UDI-DI: 10195327486457(each)
- 40195327486458(case)
- Lot Number: 24IBH266
Distribution
Distributed nationwide across the United States.
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