PSC Industries Recalls Surgical Forceps Due to Labeling Errors
PSC Industries is recalling 40 units of Model #20-1360K surgical forceps because of typos in the inner packaging labels. The errors did not affect the part or lot numbers.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states that the defect is a labeling error that did not affect the Part Number or Lot Number, and no injuries or illnesses are reported. This aligns with the rubric for cosmetic defects or documentation issues.
Plain-English summary
PSC Industries Inc is recalling 40 units of Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K. The recall involves Lot Number 023420 with an expiration date of 2/28/2017. The devices were distributed worldwide, including nationwide in the United States and in Canada and the Philippines.
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 source text does not specify instructions for consumers or healthcare providers on how to handle the recalled units, nor does it report any illnesses or injuries associated with the labeling defects.
The recalled product
- Product
- Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords…
- Manufacturer
- PSC Industries Inc
- Hazard
- Affected units
- 40
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: 20-1360K
- Lot Number: 023420
- Expiration Date: 2/28/2017.
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 Button Switch Pen Electrodes Due to Labeling Errors
FDA (Devices) · 2012-07-18
- ModeratePSC Industries Recalls Irrigating Bayonet Forceps 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
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
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
- ModerateSutter Swyng Non-Stick Bipolar Forceps Recalled for Incorrect Package Insert Labeling
FDA (Devices) · 2020-08-12
- LowPSC Industries Recalls Button Switchpens Due to Labeling Errors
FDA (Devices) · 2012-07-18
- HighOlsen Medical Recalls Symmetry Monopolar Forceps Due to Sterile Seal Risk
FDA (Devices) · 2018-06-06
- ModerateBipolar Forceps Recall Due to Incomplete Instructions for Use
FDA (Devices) · 2022-12-14
- HighBipolar Surgical Forceps Recalled for Incomplete Instructions for Use
FDA (Devices) · 2022-12-14
- HighSurgical Bipolar Forceps Recall: Incomplete Instructions for Use
FDA (Devices) · 2022-12-14