The Recall Desk
Agency classClass IIIOur severity:LowFDA (Devices)·Z-2545-2019·Announced 2019-09-25

CooperSurgical Recalls LEEP Return Patient Pads Due to Expiration Date Errors

CooperSurgical is recalling LEEP Return Patient Pads because the expiration dates on the outer boxes have the month and day reversed compared to the individual pouches.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The issue is a documentation/packaging error regarding expiration dates, which fits the criteria for a Low severity score.

Plain-English summary

CooperSurgical, Inc. is recalling 4,930 units of LEEP Return Patient Pads (Model # 6050Pl). These pads are used in electrosurgical procedures. The recall involves Lot # 201809125 and Lot # 201809135.

The recall was initiated due to a discrepancy between the expiration dates printed on the individual pouches inside the boxes and the expiration dates printed on the outer boxes. Specifically, the month and day were reversed on the outer boxes.

The affected products were distributed in the United States (including Alaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, and West Virginia) as well as in Canada, Colombia, Japan, and Malaysia. Consumers and healthcare providers should stop using the affected products and contact the manufacturer for instructions.

The recalled product

Product
LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
Manufacturer
CooperSurgical, Inc.
Category
Medical Device — Surgical Consumables
Hazard
Affected units
4,930

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 # 201809125 & 201809135

Distribution

Distributed nationwide across the United States.

The notice also names 42 states specifically:

Related recalls

Same manufacturer · CooperSurgical, Inc.

See all →

Same hazard · mis labeling

See all →

Similar recalls