Medline Iris Scissors Recalled Due to Detachable Tip Protector Risk
Medline is recalling 324,451 sterile iris scissors because the tip protector may detach, exposing a sharp point that could puncture sterile packaging and compromise instrument sterility.
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: This is an FDA Class II recall of surgical instruments that presents a risk of harm through potential sterility compromise. No injuries, infections, or adverse events have been reported; the hazard is theoretical based on the potential failure mode.
Plain-English summary
Medline Industries, LP is recalling 324,451 units of MEDLINE STERILE IRIS SCISSORS CVD/STD (Reference DYNJ04049) from worldwide distribution. These are 4.5-inch sterile curved iris scissors used in medical and surgical settings.
The scissors are being recalled because the tip protector may detach. When the protector falls off, it exposes the sharp tip of the scissors. This sharp tip could puncture the sterile barrier system of the packaging, creating holes that may not be immediately visible to the user.
These scissors were distributed worldwide, including to locations in the United States, Canada, Hong Kong, Taiwan, and Singapore. Affected devices are identified by UDI/DI 10080196847273 across all lot numbers. Healthcare facilities and providers who have received these scissors should stop using them and contact Medline Industries, LP for instructions on return or replacement.
The recalled product
- Product
- MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sharp-object
- sterility-compromise
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 10080196847273
- all lots
Distribution
Distributed nationwide across the United States.
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