Z-2342-2018Class II

Safety Sideport Knife 1.0mm 45, REF 378210

Name: Z-2342-2018 Safety Sideport Knife 1.0mm 45, REF 378210
Creator: Beaver Visitec
Published: 2018-05-14
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2018-05-14 / Terminated / root cause: manufacturing process

FDA source

Beaver Visitec began a recall of Safety Sideport Knife 1.0mm 45, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery on 2018-05-14. FDA classified it as Class II and gives the reason as "Blades are loose in handles and may fall out due to non cured epoxy". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2342-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-14
Posted: 2018-07-02
Terminated: 2021-06-08
Recalling firm: Becton Dickinson & Co
Product: Safety Sideport Knife 1.0mm 45, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery
Product code: EMF Knife, Surgical
Reason for recall: Blades are loose in handles and may fall out due to non cured epoxy
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On May 14, 2018, Beaver-Visitec International (BVI) issued PRODUCT RECALL NOTICES to customers. Customers were advised to take the following actions: -Inspect stock, quarantine and destroy product per internal procedures. -Complete and return the response form via email to [email protected] - Provide objective evidence of product destruction with BVI so that credit to customer accounts can be applied. Customers with questions may contact the firm by calling 866-906-8080.
Quantity in commerce: 1354 units
Distribution: US Nationwide in the states of CA, IA, CO, HI, IA, MD & TX
Product codes and lots: Lot Numbers: 6002436 & 6002663

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2342-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2342-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-02

Product code EMF

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)