CLASS II Device recall · Reported 18 Jul 2012 · FDA Enforcement Report

Irrigating Bayonet Forceps 8.25" Tips recalled by PSC Industries

PSC Industries is recalling Irrigating Bayonet Forceps 8.25" Tips, Electrosurgical Irrigating Bipolar Forceps, distributed nationwide in the US. The recall was initiated on 1 Jun 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/part Number: 20-0431I, Lot Number: 023340, Expiration Date: 02/28/2017.

Quantity recalled125 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1999-2012
FDA event ID: 61958
Recalling firm: PSC Industries, Louisville, KY
Classification: Class II
Status: Terminated
Recall initiated: 1 Jun 2012
FDA classified: 11 Jul 2012
Reported: 18 Jul 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

1 Jun 2012	Recall initiated by company
11 Jul 2012	Classified by FDA	+40 days
18 Jul 2012	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

Worldwide distribution: USA (nationwide) including states of: CA, CT, FL, GA, MD, MI, NC, OR, SC, and TX and countries of: Canada and Philippines.

Nationwide California Connecticut Florida Georgia Maryland Michigan North Carolina Oregon South Carolina Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

Model/part Number: 20-0431I, Lot Number: 023340, Expiration Date: 02/28/2017.

Where was it sold?

Worldwide distribution: USA (nationwide) including states of: CA, CT, FL, GA, MD, MI, NC, OR, SC, and TX and countries of: Canada and Philippines.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 61958

This product is part of a recall event; the main page for the event is Bayonet Forceps 7.-1/8 Non-Insulated Tips recalled by PSC Industries.

Reported	Class	Recall	Company	Reason	Where
18 Jul 2012	CLASS II	Bayonet Forceps 7.-1/8 Non-Insulated Tips recalled by PSC Industries	PSC Industries	Foreign Material	Nationwide
18 Jul 2012	CLASS II	Bayonet Forceps 7.75" Tips Non-Stick recalled by PSC Industries	PSC Industries	Labeling Errors	Nationwide
18 Jul 2012	CLASS II	Bayonet Forceps 8.5" Serrated Tips recalled by PSC Industries	PSC Industries	Labeling Errors	Nationwide
18 Jul 2012	CLASS II	Bayonet Forceps 7.-1/8 Insulated Tips recalled by PSC Industries	PSC Industries	Labeling Errors	Nationwide
18 Jul 2012	CLASS II	Bayonet Forceps 8.25 Tips, Sterile Single Use recalled by PSC Industries	PSC Industries	Sterility	Nationwide

More recalls from PSC Industries

All 8

Reported	Class	Recall	Company	Reason	Where
18 Jul 2012Device	CLASS II	Bayonet Forceps 8.25 Tips, Sterile Single Use recalled by PSC Industries	PSC Industries	Sterility	Nationwide
18 Jul 2012Device	CLASS II	Bayonet Forceps 7.-1/8 Insulated Tips recalled by PSC Industries	PSC Industries	Labeling Errors	Nationwide
18 Jul 2012Device	CLASS II	Bayonet Forceps 8.5" Serrated Tips recalled by PSC Industries	PSC Industries	Labeling Errors	Nationwide
18 Jul 2012Device	CLASS II	Button Switchpens, w/Extendable Needle Electrode Exposure recalled	PSC Industries	Labeling Errors	Nationwide
18 Jul 2012Device	CLASS II	Button Switchpens, w/Extendable Needle Electrode Exposure Single Use recalled	PSC Industries	Labeling Errors	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide