Medline wire cut scissors may have weak seal compromising sterility
Medline Industries is recalling 800 units of 4.5-inch wire cut scissors due to a weak seal that could compromise sterility if it fails during use or storage.
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 Class II FDA medical device recall with no reported illnesses or injuries. The hazard is a potential sterility breach on surgical instruments, which represents a risk-of-harm to patients but has not resulted in documented patient harm. Per the rubric, recalls with theoretical hazards and no reported injuries score at most 3.
Plain-English summary
Medline Industries is recalling 800 units of its 4.5-inch wire cut scissors (Product Code DYND04006, Lot Number 2023031390) because the product may have a weak seal that could result in a breach of sterility if the seal fails.
According to the manufacturer, the weak seal is not easily detectable by all users, meaning affected products could potentially be used without awareness that sterility has been compromised. For surgical instruments, loss of sterility could pose a risk during medical procedures.
The affected scissors were distributed worldwide, including throughout the United States, Panama, and Canada. Users who have received this product should stop using it and contact Medline Industries for instructions regarding replacement or proper handling.
The recalled product
- Product
- MEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 800
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 40884389097350 (case) 10884389097359 (each)
- Lot Numbers: 2023031390
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 29 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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