Medline Surgical Scissors Recalled for Sterility Seal Defect
Medline O.R. scissors may have weak seals that compromise sterility, increasing risk of contamination and infection. Approximately 21,440 units from lot 2023052490 have been recalled nationwide.
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: FDA Class II medical device with potential for serious harm through contamination and infection. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Medline Industries has recalled O.R. scissors (5.5 inches, sterile, Item No. DYND04000) due to weak seals on the packaging. Approximately 21,440 units have been affected.
Weak seals may cause the sterile packaging to be breached without being visibly detectable to the user. This creates a risk that surgical instruments could become contaminated during storage or handling, potentially leading to infection when used in medical procedures.
Affected units are identified by Lot 2023052490 and have been distributed across the United States. Consumers who have these scissors should not use them and should contact Medline Industries for instructions on what to do next.
The recalled product
- Product
- O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterility-breach
- contamination
- infection
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)
- UDI: 10193489191349 (ea) 20193489191346 (case)
- Lot 2023052490
Distribution
Distributed nationwide across the United States.
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