FDA Medical Device Recalls (openFDA)
CooperSurgical, Inc.: LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
- Recall number
- Z-2545-2019
- Recalling firm
- CooperSurgical, Inc.
- Product
- LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
- Status
- Terminated
- Initiated
- 2019-08-19
- Posted
- not on file
- Terminated
- 2020-07-14
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- Firm sent letter 8/19/2019. 1. Please discard the outer master 10- pack box containing barcode label . 2. Keep the individual seal pouches with correct expiration date. 3. Complete and return the acknowledgement and receipt form. 4. To return the product, Qurantine the affected product, complete and retun the acknowledegment and receipt form to CooperSurgical. If you have additional questions, please contact a CooperSurgical Product Surveillance representative at 203.601.5200 Ext. 3300 or email us at recall@coopersurgical.com.
- Quantity
- 4930 units
- Distribution
- 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, serial or model codes
- Lot # 201809125 & 201809135
- 510(k) numbers
- ["K120476"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 1216677
- Firm city
- Trumbull
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28