Z-1539-2018Class II

WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free...

Name: Z-1539-2018 WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free...
Creator: Beaver-Visitec International Inc.
Published: 2018-02-26
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2018-02-26 / Terminated / root cause: manufacturing process

FDA source

Beaver-Visitec International Inc. began a recall of WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that can be used as a precise... on 2018-02-26. FDA classified it as Class II and gives the reason as "Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip". 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-1539-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-26
Posted: 2018-04-27
Terminated: 2019-01-28
Recalling firm: Becton Dickinson & Co
Product: WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedures.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On February 26, 2018, Beaver Visitec International Inc. emailed Product Recall Notices to affected customers. The letter identified the affected device and the reason for the recall. Customers were instructed to destroy affected product, provide evidence of the destruction, and complete a customer response form. Customers will receive a credit. Customers with questions regarding the recall may contact Customer Service at (866)906-8080.
Quantity in commerce: 110 total products
Distribution: Distributed to the states of OH, NY, FL, MN, and KS.
Product codes and lots: Lot numbers: 6000292 exp. 7/25/20 and 6000540 exp. 08/30/20 UDI: 30886158014899

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1539-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1539-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-04-27

Product code GEI

K911160Class IIMentor(r) Wet-Field(r) II Ac Coagulator, 22-1305Mentor O & O, Inc. / cleared 1991-05-02

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)