Z-1957-2019Class II

E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then...

Name: Z-1957-2019 E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then...
Creator: Richard Wolf Medical Instruments Corp.
Published: 2019-05-23
License: https://open.fda.gov/license/

Richard Wolf Medical Instruments Corp. / initiated 2019-05-23 / Terminated / root cause: packaging

FDA source

Richard Wolf Medical Instruments Corp. began a recall of E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged... on 2019-05-23. FDA classified it as Class II and gives the reason as "E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1957-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-23
Posted: 2019-06-13
Terminated: 2020-08-04
Recalling firm: Richard Wolf Medical Instruments Corp.
Product: E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and/or therapy in various medical disciplines such as urology and gynecology.
Product code: HIH Hysteroscope (And Accessories)
Reason for recall: E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Richard Wolf Medical Instruments, Corp. notified customers on 05/23/2019 via "Urgent Safety Information: Recall" letter. Instructions included to examine distribution reports and stock immediately to determine if any affected devices are on hand, quarantine any affected devices, advise customers of the recall if affected devices were further distributed, and scrap all affected devices on site. Customers were also instructed to complete and return the Answer form provided with the notification letter. An updated "Urgent Safety Information: Recall" letter was sent via email on 06/07/2019 to customers. The letter contained an update to include the hazard and risk. Instructions to customers remained the same as in the original letter.
Quantity in commerce: 5 boxes (5 electrodes each)
Distribution: US nationwide distribution in the states of South Carolina, Rhode Island, and Missouri.
Product codes and lots: Product Number: 8416.0305; Batch Number: 1390827; Expiration Dates 10/15/2023 and 03/11/2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1957-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1957-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-17	2019-07-10

Product code HIH

K980302Class IIWorking Elements, Resectoscope Sheaths, Electrodes, Obturators, EndoscopesRichard Wolf Medical Instruments Corp. / cleared 1998-07-20

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)