PSC Industries Recalls Misbranded Electrosurgical Bayonet Forceps
PSC Industries is recalling 5 units of Model #41604 Bayonet Forceps because the label incorrectly states the tip size is 0.5mm when it is actually 1.0mm.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (misbranding) regarding tip size. Per the rubric, minor labeling errors and Class II recalls without reported injuries or hospitalizations fall under the Moderate severity category.
Plain-English summary
PSC Industries Inc is recalling 5 units of Electrosurgical Monopolar Reusable Bayonet Forceps, Model #41604. The recall is due to misbranding, as the product label states the tip size is 0.5mm, but the actual tip size measures 1.0mm.
The affected devices are packaged in non-sterile small plastic tubes and are intended for use in cutting and coagulating tissue during surgical procedures. The specific lot numbers involved are 019737 and 021578.
The products were distributed worldwide, including nationwide in the United States (specifically CA, CT, FL, GA, MD, MI, NC, OR, SC, and TX) and in Canada and the Philippines. Users should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- PSC Industries Inc
- Hazard
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model/part Number: 41604
- Lot Number: 019737
- and 021578.
Distribution
Part of a larger recall action
This product is one of 6 recalled by PSC Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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