Medline Sterile Iris Scissors Recall Due to Detachable Tip Protector
Medline is recalling 67,811 units of sterile iris scissors because the tip protector may detach during use. The recall affects units distributed nationwide and internationally.
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 medical device where the potential for the tip protector to detach during surgical use could affect sterile field integrity and clinical safety. The source reports no injuries or illnesses, and the hazard is explicitly described as a potential rather than a documented occurrence, placing it at most at a score of 3 per the rubric.
Plain-English summary
Medline Industries, LP is recalling 67,811 units of MEDLINE STERILE IRIS SCISSORS (Model DYNJ04049/DYNJ04049H) due to the potential for the tip protector to fall off the 4.5-inch curved scissor blades.
The affected product was distributed worldwide, including throughout the United States, Singapore, and Canada. The recall involves specific lot numbers: 23GBV681, 23HBD138, 23IBF254, and 23LBJ787.
A detached tip protector during surgical use could compromise the sterile field or create other risks in clinical settings. This is an FDA Class II recall.
Customers who have purchased these scissors should stop using them and contact Medline Industries for instructions on returning the product.
The recalled product
- Product
- MEDLINE STERILE IRIS SCISSORS CVD/STD REF DYNJ04049 (case) and DYNJ04049H (individual unit)
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 67,811
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 (5)
- UDI/DI 10080196847273
- Lot Numbers: 23GBV681
- 23HBD138
- 23IBF254
- 23LBJ787
Distribution
Distributed nationwide across the United States.
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