PSC Industries Recalls Irrigating Bayonet Forceps Due to Labeling Errors
PSC Industries is recalling 125 units of Irrigating Bayonet Forceps because of typographical errors on the inner packaging labels.
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, but the source text explicitly states the issue is a labeling error that did not affect the Part or Lot numbers, fitting the rubric for minor labeling errors.
Plain-English summary
PSC Industries Inc is recalling 125 units of Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Model #20-0431. The recall involves a specific lot (023340) with an expiration date of 02/28/2017. The devices are sterile surgical instruments intended for electro-surgery for coagulation and irrigation of tissue.
The recall was initiated due to labeling errors on the inner Tyvek peel pouch. Specifically, the letter 'E' in the word 'Electrosurgical' was printed as an 'X', and the number '5' in the tip measurement was printed as a '0'. These errors affected the description and some text on the labels but did not alter the Part Number or Lot Number.
The affected units 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. Consumers and healthcare facilities should check their inventory for this specific model and lot number and stop using the devices if they match the recalled description.
The recalled product
- 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.…
- Manufacturer
- PSC Industries Inc
- Hazard
- Affected units
- 125
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: 20-0431I
- Lot Number: 023340
- Expiration Date: 02/28/2017.
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
Same manufacturer · PSC Industries Inc
See all →- LowPSC Industries Recalls Bipolar Bayonet Forceps Due to Packaging Labeling Error
FDA (Devices) · 2012-07-18
- LowPSC Industries Recalls Surgical Forceps Due to Labeling Errors
FDA (Devices) · 2012-07-18
- LowPSC Industries Recalls Button Switch Pen Electrodes Due to Labeling Errors
FDA (Devices) · 2012-07-18
- LowPSC Industries Recalls Button Switchpens Due to Labeling Errors
FDA (Devices) · 2012-07-18
- ModeratePSC Industries Recalls Misbranded Electrosurgical Bayonet Forceps
FDA (Devices) · 2012-07-18
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateOlsen Medical Recalls Bipolar Forceps Due to Sterile Seal Risk
FDA (Devices) · 2018-06-06
- LowPSC Industries Recalls Button Switchpens Due to Labeling Errors
FDA (Devices) · 2012-07-18
- ModerateCarefusion Bipolar Surgical Forceps Recalled for Missing Instructions
FDA (Devices) · 2022-12-14
- HighOlsen Medical Recalls Symmetry Monopolar Forceps Due to Sterile Seal Risk
FDA (Devices) · 2018-06-06
- ModerateSutter Swyng Non-Stick Bipolar Forceps Recalled for Incorrect Package Insert Labeling
FDA (Devices) · 2020-08-12
- LowPSC Industries Recalls Button Switch Pen Electrodes Due to Labeling Errors
FDA (Devices) · 2012-07-18