CooperSurgical LEEP Loop Electrode Recalled for Outer Box Mislabeling
CooperSurgical is recalling LEEP Radius Loop Electrodes because the outer box is mislabeled with the wrong part number.
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 the hazard is a minor labeling error on the outer box without reported injuries or illnesses.
Plain-English summary
CooperSurgical, Inc. is recalling 595 units of LEEP Radius Loop Electrodes (Model R2010). The product is intended for the diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.
The recall was initiated because the outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode. The affected units are from Lot 159621 with an expiration date of 2017-05.
The affected units were distributed nationwide in the United States and internationally to Canada, Portugal, and Hong Kong. Consumers and healthcare providers should stop using the product and contact the manufacturer for instructions.
The recalled product
- Product
- CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- Affected units
- 595
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 (1)
- Lot 159621 Exp Date: 2017-05
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · CooperSurgical, Inc.
See all →- SevereCooperSurgical Recalls Neonatal Nasal CPAP Replacement Sets Due to Loose Tubing
FDA (Devices) · 2026-09-30
- SevereCooperSurgical Recalls Infant Nasal CPAP Tubing Due to Loose Connection Risk
FDA (Devices) · 2026-09-30
- HighEndosee system convenience trays label non-sterile iodine pouches as sterile
FDA (Devices) · 2025-07-30
- HighHSG procedure trays label non-sterile iodine pouches as sterile
FDA (Devices) · 2025-07-30
- HighEndosee convenience kits label non-sterile iodine pouches as sterile
FDA (Devices) · 2025-07-30
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
- HighCooperSurgical Wallach Loop Electrode recalled for incorrect packaging
FDA (Devices) · 2021-06-16
- LowCooperSurgical Recalls LEEP Return Patient Pads Due to Expiration Date Errors
FDA (Devices) · 2019-09-25
- ModerateCooperSurgical LEEP REDIKIT Recalled for Incorrect Lidocaine Concentration Labeling
FDA (Devices) · 2015-10-14
- ModerateCooperSurgical Recalls Mislabeled Os Finder Cervical Dilators
FDA (Devices) · 2020-07-15
- LowCooper Surgical Cube Pessary Recalled Due to Mislabeled Outer Packaging
FDA (Devices) · 2013-04-03
- LowCooper Surgical Cube Pessary Recalled for Mislabeled Outer Packaging
FDA (Devices) · 2013-04-03