Z-2309-2026Class II

Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife

Name: Z-2309-2026 Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife
Creator: SSC- Surgical Specialties Corporation
Published: 2026-04-23
License: https://open.fda.gov/license/

SSC- Surgical Specialties Corporation / initiated 2026-04-23 / Open, Classified / root cause: labeling and UDI

FDA source

SSC- Surgical Specialties Corporation began a recall of Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife on 2026-04-23. FDA classified it as Class II and gives the reason as "3.0mm surgical knives labeled and packaged as 2.2mm surgical knives". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2309-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-23
Posted: 2026-06-04
Recalling firm: SSC- Surgical Specialties Corporation
Product: Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife
Product code: HNN Knife, Ophthalmic
Reason for recall: 3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: On August 22, 2026, Surgical Specialties Corp. (subsidiary of Corza Medical) issued a Urgent Medical Device recall notification via E.Mail to affected consignees. Surgical Specialties ask consignees to take the following actions: 1. Immediately examine your inventory and quarantine product subject to recall. We request the return of any affected product that may still be in your inventory. We will replace the product 2. Recall Acknowledgement & Receipt Please complete and return the attached Medical Device Recall Acknowledgement & Receipt form as soon as possible to [email protected]. 3. To initiate a return, contact [email protected] to process the request. 4. If you have any questions related to product quality, contact us at [email protected].
Quantity in commerce: 1818 units
Distribution: Worldwide - US Nationwide distribution in the states of Texas, Utah, Michigan and the countries of Turkey, Germany, Romania, Poland, United Kingdom.
Product codes and lots: UDI-DI 00848782027514; Lot Number FA22CHQ

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2309-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2309-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-06-04

Product code HNN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)