LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
FDA Device Recall #Z-2545-2019 — Class III — August 19, 2019
Recall Summary
| Recall Number | Z-2545-2019 |
| Classification | Class III — Low risk |
| Date Initiated | August 19, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | CooperSurgical, Inc. |
| Location | Trumbull, CT |
| Product Type | Devices |
| Quantity | 4930 units |
Product Description
LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
Reason for Recall
Discrepancy between the correct expiration dates on the individual pouches inside the boxes and incorrect expiration dates on the outer boxes, where the month and day were reversed.
Distribution Pattern
USA: AK, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, & WV. Distribution US nationwide, Canada, Colombia, Japan, & Malaysia
Lot / Code Information
Lot # 201809125 & 201809135
Other Recalls from CooperSurgical, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2136-2025 | Class II | Endosee System Convenience Kit. Model Number: E... | Jun 11, 2025 |
| Z-2135-2025 | Class II | HSG Procedure Tray. Model Number: 6050T. Th... | Jun 11, 2025 |
| Z-2137-2025 | Class II | Endosee System Convenience Kit with IV Tube. Mo... | Jun 11, 2025 |
| Z-0687-2025 | Class II | Brand Name: K-Systems Product Name: G73 Dry Ba... | Nov 15, 2024 |
| Z-0688-2025 | Class II | Brand Name: K-Systems Product Name: G85 Mini I... | Nov 15, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.