FDA Recalls Stradis Medical Surgical Scissors Due to Compromised Sterile Barrier
Stradis Medical is recalling NARMD MEDICAL DEPOT Iris Curved Scissors (Part Number ZZ-0697) because the sterile barrier may be compromised, potentially exposing patients to contamination during surgical procedures.
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 risk-of-harm product (surgical scissors) where the compromised sterile barrier could lead to patient contamination during use. No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed harm, placing this at Score 3 per the rubric.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697, a surgical instrument used in medical procedures.
The sterile barrier of the affected units may be compromised. Surgical instruments rely on an intact sterile barrier to ensure they remain free from contamination. If the barrier is compromised, these scissors may introduce contamination when used in sterile surgical fields.
The recall affects 50 units with lot numbers 22026482044 and 22152487922 (UDI/DI: M752ZZ06970), distributed nationwide in South Carolina.
Healthcare facilities that received this product should immediately quarantine the affected units and contact Stradis Medical. These scissors should not be used in any sterile procedures until the sterile barrier integrity has been verified or the units have been replaced.
The recalled product
- Product
- NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 50
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)
- SKU/Part Number: ZZ-0697
- Lots: 22026482044 and 22152487922 UDI/DI: M752ZZ06970
Distribution
Part of a larger recall action
This product is one of 3 recalled by Stradis Medical, LLC dba Stradis Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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