Richard Wolf Recalls E-Line Cutting Electrode Due to Incorrect Product Packaging
Richard Wolf Medical Instruments Corp. is recalling E-Line Cutting Electrodes because some packages contain the wrong electrode type.
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 minor labeling/packaging error where the wrong product type is included, without reported injuries or illnesses.
Plain-English summary
Richard Wolf Medical Instruments Corp. is recalling E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile (Product Number 8416.0305). The recall is due to a packaging error where some packages labeled as E-Line Cutting Electrode 8416.0305 actually contain an E-Line Hook Electrode 8416.09 instead of the intended cutting electrode.
The affected products were distributed in the United States, specifically in South Carolina, Rhode Island, and Missouri. The recalled items are identified by Batch Number 1390827 and have expiration dates of 10/15/2023 and 03/11/2024. Each box contains five packaged electrodes.
Healthcare providers and patients should stop using the affected electrodes and contact Richard Wolf Medical Instruments Corp. for instructions on returning the product. This recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue.…
- Manufacturer
- Richard Wolf Medical Instruments Corp.
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)
- Product Number: 8416.0305
- Batch Number: 1390827
- Expiration Dates 10/15/2023 and 03/11/2024
Distribution
Related recalls
Same manufacturer · Richard Wolf Medical Instruments Corp.
See all →- HighRichard Wolf Conical Portio Adapter Recall Due to Weld Defect
FDA (Devices) · 2016-08-31
- ModerateRichard Wolf Vesa 75/100 Adaptation Recalled for Missing Rivets
FDA (Devices) · 2016-03-23
- HighRichard Wolf Reusable Rotary Blade Recalled for Weak Welds
FDA (Devices) · 2016-02-17
- HighRichard Wolf Reusable Rotary Blade Recall Due to Weak Welds
FDA (Devices) · 2016-02-17
- HighRichard Wolf Reusable Rotary Blade Recalled for Weak Welds
FDA (Devices) · 2016-02-17
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
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateRichard Wolf Recalls S(a)line Resectoscope Vaporization Electrodes Due to Packaging Error
FDA (Devices) · 2013-11-13
- HighMislabeled Cutting Electrode May Contain Wrong Electrode Type
FDA (Devices) · 2021-08-18
- ModerateKarl Storz Cutting Electrode Recall Due to Packaging Damage
FDA (Devices) · 2013-05-22
- HighRichard Wolf Recalls Hulka Clip Tubal Occluding Device Lot 51000232
FDA (Devices) · 2014-10-15
- ModerateKarl Storz Cutting Electrodes Recalled for Packaging Damage
FDA (Devices) · 2013-05-22
- ModerateKarl Storz VaporCut Electrode Recalled for Packaging Damage
FDA (Devices) · 2013-05-22