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

Bayonet Forceps 5" Serrated Tips Electrosurgical/Monopolar recalled

PSC Industries is recalling Bayonet Forceps 5" Serrated Tips Electrosurgical/Monopolar Forceps/Reusable, 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: 41604, Lot Number: 019737, and 021578.

Quantity recalled5 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-1995-2012
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: Labeling Errors
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 their Electrosurgical Monopolar Reusable Bayonet Forceps are misbranded in that the label states that the tip size is: (0.5mm) when the tip size actually measures (1.0mm).

Product as listed by the FDA

Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes. Monopolar Reusable Forceps - are intended for use in cutting and coagulating tissue during surgical procedures.

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

Is Bayonet Forceps 5" Serrated Tips Electrosurgical/Monopolar Forceps/Reusable recalled?

Yes. PSC Industries recalled Bayonet Forceps 5" Serrated Tips Electrosurgical/Monopolar Forceps/Reusable on 1 Jun 2012. The recall is Class II and its status is Terminated. Recall number Z-1995-2012.

Why was it recalled?

Which lots are affected?

Model/part Number: 41604, Lot Number: 019737, and 021578.

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.

More recalls from PSC Industries

All 8

Reported	Class	Recall	Company	Reason	Where
18 Jul 2012Device	CLASS II	Bayonet Forceps 25 Tips, Sterile Single Use Surgical/Bipolar Forceps recalled	PSC Industries	Sterility	Nationwide
18 Jul 2012Device	CLASS II	Bayonet Forceps -1/8 Insulated 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	Irrigating Bayonet Forceps 25" Tips recalled by PSC Industries	PSC Industries	Sterility	Nationwide
18 Jul 2012Device	CLASS II	Button Switchpens, w/Extendable Needle Electrode Exposure Single Use recalled	PSC Industries	Labeling Errors	Nationwide

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