Recalls / —

—#210922

Product

Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)

FDA product code

LRW — Scissors, General, Surgical

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

UDI-DI: 10080196847273 Lots 23GBV681 23HBD138 23IBF254 23LBJ787

Why it was recalled

Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

This is an expansion of recall RES 92881, which was originally initiated on April 30, 2024. Additional impacted customers were identified and notified on October 7, 2024. Customers were instructed to destroy any affected product on hand. The firm will issue credit for affected product.

Recalling firm

Firm

MEDLINE INDUSTRIES, LP Northfield

Address

3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern

US Nationwide distributions in the states of AL, AR, CO, CT, FL, IA, IN, KS, LA, MA, MO, NC, NY, OK, OR, RI, TN, TX, VA, WA, WY.

Timeline

Recall initiated

2024-10-21

Posted by FDA

2024-11-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #210922. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.