Medline Iris Scissors Recalled for Potential Sterility Barrier Compromise
Medline is recalling 69,611 single-use iris scissors because the tip protector may fall off during packaging, compromising the sterile barrier. Affected units were distributed nationwide to 20 states.
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 Class II recall of medical devices where the sterile barrier may be compromised, posing an infection risk if non-sterile instruments are used in clinical settings. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury are scored at 3.
Plain-English summary
Medline Industries is recalling 69,611 single-use iris scissors (Model DYNJ04049 for cases, DYNJ04049H for individual units) due to a sterility risk.
The tip protector may fall off within the packaging, which could compromise the sterile barrier system and result in loss of sterility. This poses a potential infection risk if non-sterile scissors are used in clinical settings.
The recalled scissors were distributed nationwide to healthcare facilities in 20 states: Alabama, Arkansas, Colorado, Connecticut, Florida, Iowa, Indiana, Kansas, Louisiana, Massachusetts, Missouri, North Carolina, New York, Oklahoma, Oregon, Rhode Island, Tennessee, Texas, Virginia, Washington, and Wyoming. Affected lot numbers are 23GBV681, 23HBD138, 23IBF254, and 23LBJ787.
Healthcare providers and facilities should immediately stop using the recalled scissors and contact Medline Industries for instructions on returns or replacements.
The recalled product
- Product
- Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 69,611
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 (1)
- UDI-DI: 10080196847273 Lots 23GBV681 23HBD138 23IBF254 23LBJ787
Distribution
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