Medline O.R. Scissors Recalled Due to Sterile Packaging Compromise Risk
Medline is recalling approximately 189,221 surgical scissors because they were manufactured without a tip protector, allowing them to break through sterile packaging and compromise product sterility.
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: FDA Class II recall involving risk-of-harm (compromised sterility on surgical instruments). No illnesses, injuries, or deaths have been reported, meeting the rubric criteria for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000. The scissors were manufactured without a tip protector, which can result in the scissors breaking through the semi-rigid plastic tray and compromising the sterility of the product.
The recall affects approximately 189,221 units distributed nationwide throughout the United States. Consumers and healthcare facilities should verify their inventory against the affected lot numbers: 23BBI031, 23BBK353, 23BBP830, 23BBQ676, 23BBR546, 23CBH009, 23CBL930, 23CBP165, 23BBS369, 23BBT718, 23CBV064, 23CBW834, 23CBV222, 23CBW020, and 23CBQ190.
The recalled product
- Product
- Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 189,221
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)
- Lot numbers and UDI numbers: 23BBI031
- 01100801968242291023BBI031
- 23BBK353
- 01100801968242291023BBK353
- 23BBP830
- 01100801968242291023BBP830
- 23BBQ676
- 01100801968242291023BBQ676
- 23BBR546
- 01100801968242291023BBR546
- 23CBH009
- 01100801968242291023CBH009
- 23CBL930
- 01100801968242291023CBL930
- 23CBP165
- 01100801968242291023CBP165
- 23BBS369
- 01100801968242291023BBS369
- 23BBT718
- 01100801968242291023BBT718
Distribution
Distributed nationwide across the United States.
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