Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips… recallZ-1995-2012 · PSC Industries Inc · initiated Jun 1, 2012
Class II Terminated All recalls posted in July 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from PSC Industries Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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).
FDA root cause category: Labeling mix-ups
What the company is doing
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.
Recall details
- Recall number
- Z-1995-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 1, 2012
- Posted by the FDA
- Jul 12, 2012
- Recalling firm
- PSC Industries Inc
- Quantity
- 5 units
- Product code
- GEI
- FDA submissions
- K982705
- 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 description
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.
Code information (models, lots, serial numbers)
Model/part Number: 41604, Lot Number: 019737, and 021578.
Other devices under the same FDA submission
1 device cleared under K982705 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Symmetry Olsen 90-8012Aspen Surgical Products, Inc. · Electrosurgical, Cutting & Coagulation & Accessories1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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