Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife
Summary
The FDA issued a Class II for Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsu by SSC- Surgical Specialties Corporation. Reason: 3.0mm surgical knives labeled and packaged as 2.2mm surgical knives..
Details
Source
Device Recall
External ID
Z-2309-2026
Action Date
2026-06-10
Status
Ongoing
Category
device
Product Description
Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife
Lot/Code Info: UDI-DI 00848782027514; Lot Number FA22CHQ
Quantity Affected: 1818 units
Reason for Recall
3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.
Distribution
Worldwide - US Nationwide distribution in the states of Texas, Utah, Michigan and the countries of Turkey, Germany, Romania, Poland, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-23
Company
Chula Vista, CA
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 169 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (SSC- Surgical Specialties Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SSC- Surgical Specialties Corporation have FDA actions?
This is the only FDA action we have on record for SSC- Surgical Specialties Corporation in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2309-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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