SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000
Summary
The FDA issued a Class II for SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000 by Medline Industries, LP. Reason: The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if p.
Details
Source
Device Recall
External ID
Z-0921-2026
Action Date
2025-12-24
Status
Ongoing
Category
device
Product Description
SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000
Lot/Code Info: DYND04000, UDI-DI: 10193489191349(each), 20193489191346(case), Lot Number: 2023102590
Quantity Affected: 56 units
Reason for Recall
The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.
Distribution
US Nationwide distribution in the states CA, CO, IL, KS, and MI.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-13
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 208 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0921-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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