Z-1999-2012Class II

Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model...

Name: Z-1999-2012 Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model...
Creator: PSC Industries Inc
Published: 2012-06-01
License: https://open.fda.gov/license/

Olsen Medical / initiated 2012-06-01 / Terminated / root cause: labeling and UDI

FDA source

PSC Industries Inc began a recall of Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Each unit of this... on 2012-06-01. FDA classified it as Class II and gives the reason as "Firm officials reported to CIN-DO that for this device, in the labeling on the inner Tyvek peel pouch, the letter 'E' in Electrosurgical was turned into an 'X' and the number '5" of the (mm tips) was turned into a '0'...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1999-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-01
Posted: 2012-07-12
Terminated: 2015-09-15
Recalling firm: Olsen Medical
Product: Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Each unit of this sterile surgical device is packaged in a Tyvek peel pouch in boxes which contain five (5)Tyvek peel pouches per box. Bayonet Bipolar Irrigating Forceps are intended for use in electro-surgery for coagulation and irrigation of tissue.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Firm officials reported to CIN-DO that for this device, in the labeling on the inner Tyvek peel pouch, the letter 'E' in Electrosurgical was turned into an 'X' and the number '5" of the (mm tips) was turned into a '0'. This affected the description and some of the text of the labels. However, it did not t affect the Part Number and Lot Number on the label.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The firm, Olsen Medical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 5, 2012 to their customers via Certified mail along with representative labeling to illustrate the specific labeling issue associated with the various types and/or sizes of Bayonet Forceps surgical instruments that the customers received. The letter described the product, problem and actions to be taken. The letter instructed the customers to immediately examine their inventory for the presence of the suspect product and quarantine the product, if found; to discontinue use immediately and promptly call (800) 251-3000 for a 'Return Material Authorization (RMA) number; to complete and return the enclosed 'Recall Response Form' and fax the completed form to the fax number on the form or to send the completed form back to the recalling firm via parcel post, and for customers who may have further distributed the recalled product are asked to contact their (sub-account) customers and notify them of the recall. If you have any questions call (615) 964-5515 M-F 8:00 am - 5:00 pm CST.
Quantity in commerce: 125 units
Distribution: Worldwide distribution: USA (nationwide) including states of: CA, CT, FL, GA, MD, MI, NC, OR, SC, and TX and countries of: Canada and Philippines.
Product codes and lots: Model/part Number: 20-0431I, Lot Number: 023340, Expiration Date: 02/28/2017.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1999-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1994-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-11
Z-1995-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-11
Z-1996-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-11
Z-1997-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-11
Z-1998-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-11
Z-1999-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-11

Product code GEI

K885199Class II#500 Series Forceps W/cut/coagulate SwitchesOlsen Electrosurgical, Inc. / cleared 1989-01-13

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)