Z-2545-2019Class III

LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures

Name: Z-2545-2019 LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures
Creator: CooperSurgical, Inc.
Published: 2019-08-19
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2019-08-19 / Terminated / root cause: packaging

FDA source

CooperSurgical, Inc. began a recall of LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures on 2019-08-19. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2545-2019
Classification: Class III
Status: Terminated
Initiated: 2019-08-19
Posted: 2019-09-16
Terminated: 2020-07-14
Recalling firm: CooperSurgical, Inc.
Product: LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: packaging
FDA 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 [email protected].
Quantity in commerce: 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
Product codes and lots: Lot # 201809125 & 201809135

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2545-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2545-2019	Class III	Terminated	Voluntary: Firm initiated	2019-09-25	2019-09-16

Product code GEI

K120476Class IIMacrolyte Dispersive ElectrodeConmed Corporation / cleared 2012-06-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)