Medline Contro-Bulb Syringe Recalled for Potential Sterile Barrier Breach
Medline is recalling 4,831 Contro-Bulb Syringes due to potential sterile barrier breach during transportation. The recall affects two lot numbers and applies nationwide.
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 with no reported illnesses or injuries. The potential sterile barrier breach on a medical device presents contamination risk but no confirmed harm; this qualifies as a 'risk-of-harm product where injury has not yet been reported' per FDA rubric.
Plain-English summary
Medline Industries, LP is recalling 4,831 units of the Contro-Bulb Syringe (REF DYND20125), a bulb irrigation syringe. The recall was issued after packaging material was updated and subsequent testing indicated the potential for the sterile barrier to be breached during transportation.
The affected syringes are distributed nationwide across the United States and are identified by lot numbers 96922110001 and 96923100001. Product identifiers include UDI/DI 40080196031765 (case level) and 10080196031764 (unit level).
A breached sterile barrier would compromise the device's safety for medical use. Facilities and users who have syringes with the affected lot numbers should verify their inventory against this recall. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 4,831
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/DI 40080196031765 (case)
- 10080196031764 (unit) Lot Numbers: 96922110001 and 96923100001
Distribution
Distributed nationwide across the United States.
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